ArticlePDF Available

Abstract and Figures

Objective This study assesses the effectiveness of face‐to‐face group positive psychotherapy for cancer survivors (PPC) compared to its online adaptation, online group positive psychotherapy for cancer survivors (OPPC), which is held via videoconference. A two‐arm, pragmatic RCT was conducted to examine the effects of both interventions on emotional distress, posttraumatic stress (PTSS) and posttraumatic growth (PTG) among cancer survivors and analyze attrition to treatment. Methods Adult women with a range of cancer diagnoses were invited to participate if they experienced emotional distress at the end of their primary oncological treatment. Emotional distress, PTSS and PTG were assessed at baseline, immediately after treatment and three months after treatment. Intention‐to‐treat analyses were carried out using general linear mixed models to test the effect of the interventions overtime. Logistic regressions were performed to test differential adherence to treatment and retention to follow‐up. Results A total of 269 individuals participated. The observed treatment effect was significant in both modalities, PPC and OPPC. Emotional distress (b = − 2.24, 95%CI = ‐3.15‐ −1.33) and PTSS (b = − 3.25, 95%CI = ‐4.97‐ −1.53) decreased significantly over time, and PTG (b = 3.08, 95%CI = 0.38‐5.78) increased significantly. Treatment gains were sustained across outcomes and over time. Analyses revealed no significant differences between modalities of treatment, after adjusting for baseline differences, finding that OPPC is as effective and engaging as PPC. Conclusions The OPPC treatment was found to be effective and engaging for female cancer early survivors. These results open the door for psycho‐oncology interventions via videoconference, which are likely to lead to greater accessibility and availability of psychotherapy. This article is protected by copyright. All rights reserved.
Content may be subject to copyright.
For Peer Review
1
TITLE: VIDEO CONFERENCE vs. FACE-TO-FACE GROUP PSYCHOTHERAPY FOR
DISTRESSED CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL
Positive psychotherapy for distressed cancer survivors
AUTHORS: María Lleras de Frutos1,2,Joan Carles Medina3,4, Jaume Vives5, Anna Casellas-
Grau6,7,Jose Luis Marzo8,Josep M. Borràs3,9, Cristian Ochoa-Arnedo1, 2,3
1. Psycho-Oncology Department and ICOnnecta’t e-health program, InstitutCatalàd'Oncologia,
L’Hospitalet de Llobregat, Barcelona, Spain
2. Clinical Psychology and Psychobiology Department, Universitat de Barcelona, Barcelona,
Spain
3. Institut d’Investigació Biomèdica de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
4. Department of Psychology and Educational Sciences, Universitat Oberta de Catalunya,
Barcelona, Spain
5. Department of Psychobiology and Methodology of Health Sciences and Sport Research
Institute, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Barcelona, Spain
6. Psychosocial Observatory in Cancer, Institut Català d'Oncologia. L'Hospitalet de Llobregat,
Barcelona, Spain.
7. Universitat de Vic - Universitat Central de Catalunya.
8. Universitat de Girona, Girona, Spain
9. DepartmentofClinical Science, Universitat de Barcelona, Barcelona, Spain
Corresponding author:
Cristian Ochoa Arnedo, PhD, Clinical Psychologist
Psycho-Oncology and ICOnnecta’t e-health program, Duran I Reynals Hospital, Catalan Institute of
Oncology
Av. Gran Via de l’Hospitalet, 199-203, L’Hospitalet de Llobregat, 08908 Barcelona, Spain
Tel.: (+34) 93 335 70 11 (ext. 3821); fax: (+34) 93 260 71 81
Email: cochoa@iconcologia.net
Page 1 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
2
ORCID
C. Ochoa: https://orcid.org/0000-0002-4508-0951
M. Lleras: https://orcid.org/0000-0002-7767-1625
J.C. Medina: https://orcid.org/0000-0002-4550-2157
J. Vives: https://orcid.org/0000-0001-5412-7275
A. Casellas-Grau: https://orcid.org/0000-0003-2919-0509
JM. Borras: https://orcid.org/0000-0002-5981-4047
ABSTRACT
Objective: This study assesses the effectiveness of face-to-face group positive psychotherapy for
cancer survivors (PPC) compared to its online adaptation, online group positive psychotherapy for
cancer survivors (OPPC), which is held via videoconference. A two-arm, pragmatic RCT was
conducted to examine the effects of both interventions on emotional distress, posttraumatic stress
(PTSS) and posttraumatic growth (PTG) among cancer survivors and analyze attrition to treatment.
Methods: Adult women with a range of cancer diagnoses were invited to participate if they
experienced emotional distress at the end of their primary oncological treatment. Emotional distress,
PTSS and PTG were assessed at baseline, immediately after treatment and three months after
treatment. Intention-to-treat analyses were carried out using general linear mixed models to test the
effect of the interventions overtime. Logistic regressions were performed to test differential
adherence to treatment and retention to follow-up.
Results: A total of 269 individuals participated. The observed treatment effect was significant in both
modalities, PPC and OPPC. Emotional distress (b=-2.24, 95%CI=-3.15– -1.33) and PTSS (b=-3.25,
95%CI=-4.97– -1.53) decreased significantly over time, and PTG (b=3.08, 95%CI=0.38–5.78)
increased significantly. Treatment gains were sustained across outcomes and over time. Analyses
revealed no significant differences between modalities of treatment, after adjusting for baseline
differences, finding that OPPC is as effective and engaging as PPC.
Conclusions: The OPPC treatment was found to be effective and engaging for female cancer early
survivors. These results open the door for psycho-oncology interventions via videoconference, which
are likely to lead to greater accessibility and availability of psychotherapy.
Keywords: cancer; oncology; survivors; videoconference; group videoconference; online group
psychotherapy; positive psychotherapy; psycho-oncology intervention; e-Health
Page 2 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
3
1. BACKGROUND
Cancer incidence is expected to increase, as is the number of patients who are successfully
treated(1). However, higher survival rates do not necessarily imply greater well-being, since several
studies show that cancer survivors have more functional limitations, risk of psychosocial problems
and emotional suffering, work-related challenges, and fears about their health than non-cancer
patients(2,3). All these consequences may lead to poorer quality of life (QoL), less adherence to
oncological treatments, lower overall survival, via less adoption of healthy lifestyles and self-care
practices when it is not treated(4–6). Although it has been shown that psycho-oncological
interventions can improve psychological adjustment, health-related QoL, emotional distress and
prevent fear of recurrence(7,8), access is far from universal. In addition to a shortage of psycho-
oncologists in national health systems, several factors may limit availability, such as: poor early
detection, long waiting times and work, mobility or time restrictions(9).
Manualized psycho-oncological treatments for emotional distress are structured as regular stage-
oriented, face-to-face interventions. They typically focus on the initial stages of cancer (i.e.,
diagnosis and active oncological therapies)(10), palliative advanced phases(11) or extended
survivorship after treatment(12). However, few studies have designed and tested specific
interventions for early survivorship, at the end of oncological primary interventions and the return to
everyday life(13). Indeed, at this transition, chronic and delayed distress trajectories converge in a
large number of survivors (30–40%)(14). Consequently, this as a suitable moment to implement
psychological treatments(5,8,13). A study on positive psychotherapy for cancer survivors
(PPC)(13,15) is one of the few that have analyzed and manualized psychological treatments to
facilitate this transition. PPC is designed to offer accurate, proper psychosocial care combining stress
management and emotional regulation (early-stage-oriented(10)) with posttraumatic growth (PTG)
facilitation via a meaning-making, existential approach (advanced-stage-oriented(11)).Group PPC
proposes that psychosocial treatment in cancer should be tailored and focus on the stress-growth
balance(13). Hence, the basic aim of PPC is to facilitate PTG and work on positive resources such as
positive emotions, strengths and personal meanings, to reduce emotional distress and posttraumatic
stress symptoms (PTSS). The first clinical trial of face-to-face PPC groups vs. treatment as usual and
waiting lists showed promising preliminary results for its efficacy to reduce distress(15). Similarly, a
recent randomized controlled trial (RCT)(16), which compared PPC groups with cognitive-
behavioral stress management groups(10), also demonstrated better PPC results.
Considering the limited access to psycho-oncology services, and the broad availability of health-
Page 3 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
4
related resources on the internet(17), online psychosocial treatments are a feasible, acceptable
alternative that has the potential to solve some of aforementioned obstacles(17,18). In psycho-
oncology settings, treatments are normally focused on patients with high emotional distress and are
preferably conducted through synchronous communication, although a wide range of options exists,
usually through the adaptation of face-to-face treatments(19,20). Some reviews have highlighted the
advantages of online psychosocial resources(17,18), including the possibility of overcoming
geographical barriers, avoiding the interpersonal discomfort associated with attending face-to-face
settings, or reducing the feeling of being overwhelmed that may be triggered by over-expression or
interactions with therapists or other patients. However, disadvantages are also described, such as loss
of non-verbal information(21) and high attrition rates(21,22). Attrition has been underlined as a
significant methodological problem in assessments of intervention effectiveness. It must be
considered in all e-health trials to prevent reduction in their power(21,22). Eysenbach(22) described
two types of attrition processes: non-usage attrition (i.e., low adherence), which describes the
phenomenon of no longer using the application; and dropout attrition (i.e., loss to follow-up or low
retention), which refers to not completing the follow-up measures.
The introduction of psycho-oncological interventions through videoconferences is an example of
contemporary solutions in practice, which offers most e-Health advantages while preventing
communication limitations, increasing engagement and even reporting slightly greater effectiveness
than face-to-face intervention in outpatient settings(20,23). Videoconferences may not replace
personal contact, but they do make synchronous treatment with a clinician possible and enhance
verbal and non-verbal communication, almost like face-to-face interventions. In cancer patients,
feasibility and acceptance has been proven for individual interventions(24) and pilot videoconference
groups are starting to appear(20,25). Despite these promising results, we have not found any
randomized clinical trials that compare the effectiveness and specific attrition rates of a synchronous
videoconference psycho-oncological group treatment for distress cancer survivors.
This study examines the impact of an online positive psychotherapy in cancer (OPPC) group, held
via videoconference, in comparison to its face-to-face PPC group counterpart. This research expands
the evidence of positive psychotherapy and e-health psycho-oncology interventions for survivors
through a pragmatic RCT to compare the effects of both interventions on distress, PTSS and PTG
among cancer survivors. We expect OPPC to be superior in this cancer-stage outpatient survivors
sample, given the advantages for videoconference interventions, including: the possibility of
overcoming geographical barriers, preventing other online communication limitations (enhancing
verbal and non-verbal communication), reducing the feeling of being overwhelmed that may be
Page 4 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
5
triggered by over-expression or interactions with therapists or other patients, therefore giving the
opportunity to increase engagement. It also analyzes attrition to treatment in terms of dropout
attrition and non-usage attrition.
2. METHODS/DESIGN
a. Study design
This pre-registered study (NCT03010371) included two consecutive clinical trials to compare 1)
face-to-face PPC vs. stress-management(16), and 2) face-to-face PPC vs. online PPC. The present
paper covers the second trial, in which a two-arm, pragmatic RCT was conducted within the routine
practice of public health centers. The pragmatic design was chosen for its potential to improve the
internal-external validity balance, and its suitability within settings where strict randomization or
concealment is not always clinically possible or acceptable(26).
b. Participants
Women with a range of cancer diagnoses were recruited between January 2016 and January 2019.
This was due to the high prevalence of high emotional distress between female breast cancer
survivors, thus favoring group homogeneity. In order to use the PPC protocol in their validated
population and guarantee group homogeneity of the sample, the trial was focused only on female
participants. They were referred, in clinical real-life settings and according to routine criteria, by
medical oncologists or nurses to the psycho-oncology unit if they presented emotional distress at the
end of their primary treatment. The psycho-oncologist carried out a face-to-face interview and
patients were asked to answer an online sociodemographic questionnaire and clinical instruments
(e.g. HADS administration). If patients met the inclusion criteria, they were invited to participate in
the study. Medical information was selected from medical histories with permission. Inclusion
criteria were: (a) age 18 years, (b) primary oncological treatment (i.e., surgery, chemotherapy,
radiotherapy) completed, (c) disease-free or clinically stable, (d) ≥10 on the Hospital Anxiety and
Depression Scales (HADS) total score, (e) access to high-speed internet and (f) competence to
understand and read Spanish. We excluded patients if they (a) reported any current severe mental
disorders or (b) any major concurrent medical disease that seriously affected their cognitive
performance. Participants were assessed at baseline (T0), immediately after treatment (T1) and three
months after treatment (T2). The study was conducted according to the latest version of the
Declaration of Helsinki. Approval was given by our hospital’s Ethics Committee (PR104/13) and all
participants signed an informed consent form.
c. Procedure
Page 5 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
6
Participants were recruited at the healthcare centers of a comprehensive cancer network in
Barcelona. Two clinical psychologists, experts in PPC, conducted or supervised the group processes.
According to our pragmatic RCT design, which was conducted within the Spanish national health
system, we aimed to provide a service to as many users as possible. Therefore, a computer-generated
randomization table with random separate allocation was prepared. After assessment, the two
modalities were described to the patients and they were encouraged to accept randomization.
However, those who showed a strong preference for one of the two options were allocated to their
treatment of choice, while all other participants were randomized. This decision entailed some risk of
bias, but may control for baseline differences in patient and clinician motivation and outcome
expectations(27). Moreover, it was decided that any between-group difference in sociodemographic
or clinical characteristics at baseline would be statistically controlled in the analyses.
Instruments
Psychological distress. HADS(28) measures anxiety and depression in people with physical illnesses,
and its overall score may be interpreted as a measure of psychological distress. Costa-Requena, Pérez
Martín, Salamero Baró, & Gil Moncayo(29) validated the tool in a Spanish sample of oncology
outpatients, with their results showing good reliability (α=.82 and α=.84 for the anxiety and
depression subscales, respectively). In our samples, similar internal consistencies were obtained
(α=.8479 for the anxiety and α=.824 for the depression scales). A score of 10 or more on HADS
total scale resulted useful for screening significant distress in a Spanish sample(29), and a change of
≥2 points has been used as a cut-off point to assess the clinical change(30).
PTSS. The Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C; 31) is a self-report that
covers the diagnostic criteria for posttraumatic stress disorder from the Diagnostic and Statistical
Manual of Mental Disorders(32). In the current sample, the total score of the PCL-C was used, which
obtained good reliability (α=.90), parallel to the Spanish validation (α=.90)(33) where a
recommended cut-o score of 44 is used to detect clinical case(33).
PTG. The Posttraumatic Growth Inventory (PTGI; 34) assesses positive changes experienced after
trauma. In this study, the total score was used, showing good reliability (α=.94) similar to that
obtained by Costa-Requena, Luis, & Moncayo(35) in the Spanish validation (α=.95).
Treatment integrity. Adherence to the protocol and therapists’ competence was assessed with an ad-
hoc questionnaire adapted and summarized from the Revised Cognitive Therapy Scale (CTS-R; 36,
37). The ad-hoc questionnaire adaptation is a summary of its more clinically relevant dimensions:
agenda (sequence of modules and tasks), conceptual integration, appropriate positive feedback,
application of positive change methods and homework tasks.
d. Interventions
Page 6 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
7
Face-to-face group positive psychotherapy for cancer survivorship (PPC)
PPC is a therapist-led group program aimed at facilitating PTG through psychotherapeutic methods
associated with the development of positive life changes after cancer. PPC is an evidence-based face-
to-face treatment consisting of 12 weekly group sessions of 90–120 minutes. Each group was
comprised of 8–12 patients, and sessions were spread across four modules, each with different
lengths and aims(15).
Online group positive psychotherapy for cancer survivorship (OPPC)
OPPC is identical to group PPC in content, but different in its delivery. OPPC is a videoconference
psycho-oncological treatment attended through an internet-enabled device from home, consisting of
11 weekly online group sessions of 90–120 minutes. The12th session is conducted in person due to
the request of patients participating in pilot OPPC groups and the review of the scientific literature,
in which cancer survivors express their need to maintain face-to-face contact at some point during
treatment or therapeutic follow-up(17). Participants who could not participate in person during the
last session (i.e., individuals who live very far from the hospital), were connected via
videoconference to this session. Headsets and webcams were provided when needed.
Participants logged in on a secure platform (ViTAM®), and in collaboration with the University of
Girona (UdG), participants could see, hear and interact in real time with all other group members and
the therapist simultaneously during the intervention. ViTAM® uses new Web-RTC (real-time
communication) technology, which allows direct connection and minimizes delays. Technical
support was provided by the UdG. However, given the ViTAM® constraints, the other main
difference was group size, with OPPC clusters formed of 5–6 patients. In all cases, the information
flows were encrypted to protect confidentiality(38).
e. Data analyses
Baseline differences between participants randomized, and those who preferred allocation to each
treatment modality were examined with chi-squared and Student’s t tests. The same analyses were
conducted between both therapy groups. In addition, we estimated treatment integrity using the T
index, which allows the use of ordinal scales. In this case, agreement was defined as identical scores
on an item using a7-point scale. Logistic regressions were performed to test differential adherence to
treatment and retention to follow-up. Missingness at baseline and variables that differed between
groups at baseline were controlled for (i.e., age, education and work status).
Intention-to-treat (ITT) analyses were performed using general linear mixed models (LMMs) to test
the effect of interventions (i.e., PPC and OPPC) on distress (HADS total score, and anxiety and
depression subscales), post-traumatic stress (PCL-C) and post-traumatic growth (PTGI) overtime
(T0, T1 and T2). Little’s MCAR test indicated that data were missing completely at random (2[248]
Page 7 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
8
= 207.67, p=.97). Since MCAR can be assumed and since maximum likelihood (ML) was the
estimation method, no missing data imputation was applied. Akaike’s Information Criterion (AIC)
and Likelihood ratio test were used, respectively, in non-nested and nested models, to guide the
modeling process. Visual inspection of residual plots did not reveal any obvious deviation from
homoscedasticity or normality.
The modeling process began with the most meaningful model close to the null. In the study, this was
the unconditional model with time as a linear fixed effect and the intercept as a random effect.
Afterwards, time was tested as a random effect. A conditional model with intervention (i.e., PPC and
OPPC) as a fixed effect was then tested and finally the interaction of the intervention with time was
entered into the model. The final model included random intercepts, and intervention, time and
control variables (i.e., age, education and work status) as fixed effects. Covariance structures that
best fitted the data were diagonal for level 1, and identity for level 2, as the only significant random
effect was the intercept. Pairwise comparisons were conducted between post-intervention and
follow-up scores with respect to the baseline, while additional LMMs were run controlling for
baseline scores to discard their influence on the results.
For all outcomes, 95% confidence intervals were calculated based on estimates and standard errors.
Statistical analyses were performed using IBM SPSS for Windows, Version 24.0(39).
3. RESULTS
a. Participant characteristics
A total of 289 individuals were assessed for eligibility (see the flow diagram in Figure 1). Before
randomization, 44 participants wanted to be allocated either to the PPC group (n=28) or the OPPC
group (n=16), while the 225 remaining individuals were randomized. During the course of the
therapy, 54 participants opted out of the study, while 50 opted out at follow-up. A final sample of
269 participants was analyzed. Individuals who accepted randomization, those who preferred PPC
and those who opted for OPPC were compared in terms of their social, demographic and clinical
characteristics. The only significant difference found between them was age (F=8.78,p<.001), since
participants who requested to receive OPPC were clearly younger (M=43.13, SD=8.30) than those
who preferred PPC (M=54.04, SD=9.00), with participants accepting randomization falling in-
between (M=49.92, SD=8.23). All other features (i.e., civil status, education level, work status,
psychiatric diagnosis, oncological diagnosis, cancer stage) as well as mean scores in the HADS,
PCL-C and PTGI did not significantly differ between groups.
Sociodemographic and clinical characteristics at base line of ITT participants in each therapy group
finally conformed can be seen in Table 1. Individuals in the PPC and the OPPC groups differed in
Page 8 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
9
terms of their mean age again, but also in their education level and work status, and in the mean on
the HADS depression subscale and the total scores. In contrast, treatment integrity was similar
between interventions, with a mean T index of 5.6 for PPC and of 5.7 for OPPC.
----Insert Figure 1.
----Insert Table 1.
b. Treatment attrition
Analyses did not reveal significant differences between interventions in attrition, either for
participants’ adherence during the intervention (b=-0.517, p=.182, 95%CI=-1.277 - 0.243) or for
retention at follow-up (b=0.316, p=.143, 95%CI=-0.107 - 0.738).
c. Effect of PPC and OPPC over time
Given the significant baseline differences that were found, the estimated treatment effects of the final
LMMs on the dependent variables were adjusted for age, education and work status.
The LMM of the effect of treatment on the HADS total score showed a significant variance in
intercepts across participants (Var(u0j) = 32.40, p<.001). Time yielded a significant fixed effect (b=-
2.24, p<.001, 95%CI=-3.15– -1.33), which showed an overall decrease in scores between baseline
and follow-up (see Figure 2), but no significant fixed effect of therapy (PPC vs. OPPC) was found
(b=1.36, p=.163, 95%CI=-0.55 – 3.27).
----Insert Figure 2.
Significant variances in intercepts were also found for the effect of treatment on HADS anxiety
(Var(u0j)=8.32, p=.003) and HADS depression (Var(u0j)=11.69, p<.001), while no significant time-
related variation in slopes was found. No significant fixed effect of therapy was found for HADS
anxiety (b=0.47, p=.387, 95%CI=-0.60 – 1.55) or HADS depression (b=0.94, p=.09, 95%CI= -0.15
– 2.03), but scores significantly decreased between baseline and follow-up, both for anxiety (b=-
1.27, p< .001, 95%CI=-1.85– -0.69) and depression (b=0.93, p=.001, 95%CI=-1.46– -0.39).
Despite the differences in HADS total and depression scores at baseline, once age, education and
work status variables had been controlled, such differences were no longer significant (HADS total,
mean difference =-1.35, p=.198; HADS depression, mean difference =-.89, p=.144). Furthermore,
we checked for possible differences between the above results and those from baseline-adjusted
Page 9 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
10
models. The same results were obtained, which highlighted the non-significant effect of treatment
modality.
The analysis of the effect of treatment on PCL-C showed significant variance in intercepts across
participants, Var(u0j)=79.75, p=.01, but no significant time-related variation in slopes was found.
Regarding fixed effects, PCL-C scores significantly decreased between baseline and follow-up (b=-
3.25, p< .001, 95%CI=-4.97– -1.53) (see Figure 2), but no statistical difference between treatments
was found (b=1.20, p=.693, 95%CI=-2.20 – 4.60).
Regarding PTGI (see Figure 2), the LMM testing the effect of treatment yielded significant variance
in intercepts across participants, Var(u0j)=337.19, p<.001, but not in slopes. Once again, the scores
significantly improved between baseline and follow-up (b=3.08, p=.025, 95%CI=0.38–5.78), with
the difference between treatments lacking significance (b=-0.59, p=.841, 95%CI=-6.40 – 5.22).
Table 2 shows the mean differences between baseline and both post-treatment and follow-up scores
in all outcomes. Please note that, differently to the LMMs reported above, these values are based on
models including interaction between intervention and time to allow the reporting of adjusted
estimations, and are only provided for descriptive purposes. The data that support the findings of this
study are available on request from the corresponding author. The data are not publicly available due
to privacy or ethical restrictions.
----Insert Table 2.
4. DISCUSION
This study addresses the urgent need to facilitate access to psycho-oncological treatments for
distressed cancer survivors, proving the effectiveness of online modalities and users’ engagement. To
our knowledge, this is the first RCT that provides evidence for the effectiveness of a synchronous
psycho-oncological, therapist-led, videoconference intervention among cancer distressed survivors.
The observed treatment effect can be regarded as clinically significant in both modalities, PPC and
OPPC. Indeed, LMMs proved that they significantly reduced emotional distress and PTSS, and
significantly increased PTG over time. In addition, treatment gains were sustained across outcomes
and over time.
In contrast, no significant differences were found between arms, either in attrition, integrity or
effectiveness, after adjusting for baseline differences. Similar adherence and retention rates between
PPC and OPPC may be related to videoconference therapies led by a recognizable health
Page 10 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
11
professional. In this sense, videoconference therapies may show lower attrition than other
asynchronous or written synchronous e-health interventions(21,22).
When compared to PPC, it was clear that OPPC was equally efficacious in reducing anxiety,
depression, and PTSS. It also facilitated PTG after the results were adjusted for age, education level
and work status, although PPC might outperform OPPC immediately after the intervention when
interaction is entered into the LMM, as suggested by results on Table 2. These results determine that
videoconference stage-oriented OPPC is not superior to PPC. However, it promotes not only distress
and stress reduction like other early-stage psycho-oncology interventions(10), but also facilitates
positive meaning-making responses such as PTG, in line with findings from previous studies on
face-to-face positive psychotherapy for cancer survivors(40). These results are relevant because
some studies highlight the need to guarantee access to psycho-oncological treatments for distressed
cancer survivors in this critical transition between the end of primary cancer treatments and return to
daily life(5,8,13).
Despite the proliferation of online interventions in response to this challenge(18), few studies have
focused on the effectiveness of synchronous communication(41). This study moves beyond testing
videoconference feasibility, which has already been proven(20,25), and analyzes effectiveness and
engagement. The relevant clinical results for OPPC open the door for an exponential increase in the
offer of psycho-oncology interventions via videoconference, which is likely to lead to an
improvement in psychotherapy accessibility and availability. This new situation is expected to
overcome existing geographical barriers and mobility limitations, and to provide an alternative to
avoid the interpersonal discomfort that may be felt in face-to-face settings(17,18).
a. Study limitations
Results from this RCT should be interpreted cautiously since, as a pragmatic RCT, there are some
limitations that need to be considered. The respect for patient treatment preferences may have partly
biased the results, although it also brings them closer to real-world clinical practice. This study does
not include a non-treatment control group because we focused on comparing treatment delivery
modalities. However, this intervention has been compared to a waiting list control group in a
previous study(15) and to other evidence-based interventions(16) with better results. Differences
found between-group at baseline were statistically controlled in the analyses. Other limitations were
the difference in the number of individuals in each group, as there were 10–12 patients in PPC and
5–6 in OPPC groups. These differences may affect the results as group sizes, not just modality, could
influence group evolution, alliance or commitment.
Page 11 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
12
b. Clinical implications
This study supports OPPC, which was found to be an efficacious psycho-oncological treatment for
female cancer survivors. Our promising results should encourage the extension and adaptation of
OPPC to men, mixed groups, adolescents or young adults, especially considering the significantly
younger age of those participants who requested to receive OPPC in our study. Furthermore, future
research may also focus on describing online group factors(42), or whether combined face-to-face
and online modes are more suitable and effective(43).
FUNDING SOURCES
We thank CERCA Programme Generalitat de Catalunya for institutional support. This study has
been funded by Instituto de Salud Carlos III through the project (FIS PI15/01278) Co funded by
European Regional Development Fund. ERDF, “a way to build Europe” //FONDOS FEDER “una
manera de hacer Europa.” Grup de recerca consolidat: Recerca en serveis sanitaris en cáncer.
2017SGR00735. This work was supported by the Grant PGC2018-100675-B-I00, Spanish Ministry
of Science, Innovation and Universities (Spain).
Conflict of interests. The authors declare no conflict of interests.
Trial registration. Registered at ClinicalTrials.gov with identification number NCT03010371.
REFERENCES
1. Malvezzi M, Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, et al. ’0. Ann Oncol
Off J Eur Soc Med Oncol. 2019;30(5):781–7.
2. Swartzman S, Booth JN, Munro A, Sani F. Posttraumatic stress disorder after cancer diagnosis
in adults: A meta-analysis. Depress Anxiety. 2017;34(4):327–39.
3. Hansen JA, Feuerstein M, Calvio LC, Olsen CH. Breast cancer survivors at work. J Occup
Environ Med. 2008;50(7):777–84.
4. Brown LF, Kroenke K, Theobald DE, Wu J, Tu W. The association of depression and anxiety
with health-related quality of life in cancer patients with depression and/or pain.
Psychooncology [Internet]. 2010;19(7):734–41. Available from:
http://doi.wiley.com/10.1002/pon.1627
5. Syrowatka A, Motulsky A, Kurteva S, Hanley JA, Dixon WG, Meguerditchian AN, et al.
Predictors of distress in female breast cancer survivors: a systematic review. Vol. 165, Breast
Cancer Research and Treatment. Springer New York LLC; 2017. p. 229–45.
Page 12 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
13
6. Giese-Davis J, Collie K, Rancourt KMS, Neri E, Kraemer HC, Spiegel D. Decrease in
depression symptoms is associated with longer survival in patients with metastatic breast
cancer: A secondary analysis. J Clin Oncol. 2011;29(4):413–20.
7. Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of psycho-oncologic
interventions on emotional distress and quality of life in adult patients with cancer: Systematic
review and meta-analysis. J Clin Oncol. 2013;31(6):782–93.
8. Tauber NM, O’Toole MS, Dinkel A, Galica J, Humphris G, Lebel S, et al. Effect of
Psychological Intervention on Fear of Cancer Recurrence: A Systematic Review and Meta-
Analysis. J Clin Oncol. 2019 Sep 18;JCO.19.00572.
9. Travado L, Reis JC, Watson M, Borràs J. Psychosocial oncology care resources in Europe: a
study under the European Partnership for Action Against Cancer (EPAAC). Psychooncology.
2017;26(4):523–30.
10. Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, et al. Cognitive-
behavioral stress management intervention decreases the prevalence of depression and
enhances benefit finding among women under treatment for early-stage breast cancer. Heal
Psychol [Internet]. 2001;20(1):20–32. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/11199062
11. Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, et al. Pilot randomized
controlled trial of individual meaning-centered psychotherapy for patients with advanced
cancer. J Clin Oncol [Internet]. 2012;30(12):1304–9. Available from: www.jco.org
12. van de Wal M, Thewes B, Gielissen M, Speckens A, Prins J. Efficacy of Blended Cognitive
Behavior Therapy for High Fear of Recurrence in Breast, Prostate, and Colorectal Cancer
Survivors: The SWORD Study, a Randomized Controlled Trial. J Clin Oncol. 2017
Jul;35(19):2173–83.
13. Ochoa Arnedo C, Casellas-Grau A. Positive Psychotherapy in Cancer: Facilitating
Posttraumatic Growth in Assimilation and Accommodation of Traumatic Experience. In:
Martin CR, Preedy VR, Patel VD, editors. Comprehensive Guide to Post-Traumatic Stress
Disorder. New York: Springer Verlag; 2016. p. 2133–49.
14. Brédart A, Merdy O, Sigal-Zafrani B, Fiszer C, Dolbeault S, Hardouin JB. Identifying
trajectory clusters in breast cancer survivors’ supportive care needs, psychosocial difficulties,
and resources from the completion of primary treatment to 8 months later. Support Care
Page 13 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
14
Cancer. 2016 Jan 1;24(1):357–66.
15. Ochoa C, Casellas-Grau A, Vives J, Font A, Borràs J-M. Positive psychotherapy for distressed
cancer survivors: Posttraumatic growth facilitation reduces posttraumatic stress. Int J Clin
Heal Psychol [Internet]. 2017 Jan;17(1):28–37. Available from:
https://linkinghub.elsevier.com/retrieve/pii/S1697260016300552
16. Ochoa-Arnedo C, Casellas-Grau A, Lleras de Frutos M, Medina JC, Vives J. Stress
management or posttraumatic growth facilitation to diminish distress in Cancer Survivors? A
Randomized Control Trial. J Posit Psychol. 2020; doi:10.1080/17439760.2020.1765005
17. Lleras de Frutos M, Casellas-Grau A, Sumalla EC, Gracia M, Borràs JM, Ochoa Arnedo C. A
systematic and comprehensive review of internet use in cancer patients: Psychological factors.
Psychooncology [Internet]. 2019;(abril):1–10. Available from:
https://onlinelibrary.wiley.com/doi/abs/10.1002/pon.5194
18. Leykin Y, Thekdi SM, Shumay DM, Muñoz RF, Riba M, Dunn LB. Internet Interventions for
Improving Psychological Well-Being in Psycho-Oncology: Review and Recommendations.
2012;21(9):1016–25.
19. Stephen J, Rojubally A, Linden W, Zhong L, Mackenzie G, Mahmoud S, et al. Online support
groups for young women with breast cancer: a proof-of-concept study. Support Care Cancer
[Internet]. 2017;25(7):2285–96. Available from: http://link.springer.com/10.1007/s00520-017-
3639-2
20. Zernicke KA, Campbell TS, Speca M, McCabe-Ruff K, Flowers S, Carlson LE. A
Randomized Wait-List Controlled Trial of Feasibility and Efficacy of an Online.
Journals@Ovid Full TextPsychosomatic Med. 2014;76(4):257–67.
21. Gorlick A, Bantum EOC, Owen JE. Internet-based interventions for cancer-related distress:
Exploring the experiences of those whose needs are not met. Psychooncology.
2014;23(4):452–8.
22. Eysenbach G. The Law of Attrition. J Med Internet Res [Internet]. 2005;7(1):1. Available
from: http://www.jmir.org/2005/1/e11/
23. Zilliacus EM, Meiser B, Lobb EA, Kelly PJ, Barlow-Stewart K, Kirk JA, et al. Are
videoconferenced consultations as effective as face-to-face consultations for hereditary breast
and ovarian cancer genetic counseling? Genet Med. 2011;13(11):933–41.
24. Yanez B, Mcginty HL, Mohr DC, Begale MJ, Dahn JR, Flury SC, et al. Feasibility,
Page 14 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
15
acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for
racially diverse men with advanced prostate cancer. Cancer [Internet]. 2015;1–9. Available
from:
http://www.embase.com/search/results?subaction=viewrecord&from=export&id=L605950937
25. Sansom-Daly UM, Wakefield CE, Bryant RA, Patterson P, Anazodo A, Butow P, et al.
Feasibility, acceptability, and safety of the Recapture Life videoconferencing intervention for
adolescent and young adult cancer survivors. Psychooncology. 2019;28(2):284–92.
26. Hotopf M. The pragmatic randomised controlled trial. Adv Psychiatr Treat [Internet]. 2002
Sep 2;8(5):326–33. Available from:
https://www.cambridge.org/core/product/identifier/S1355514600010889/type/journal_article
27. Ward E, King M, Lloyd M, Bower P, Sibbald B, Farrelly S, et al. Randomised controlled trial
of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care
for patients with depression. I: Clinical effectiveness. BMJ [Internet]. 2000 Dec
2;321(7273):1383–8. Available from:
http://www.bmj.com/cgi/doi/10.1136/bmj.321.7273.1383
28. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand
[Internet]. 1983 Jun;67(6):361–70. Available from: http://doi.wiley.com/10.1111/j.1600-
0447.1983.tb09716.x
29. Requena GC, Martín XP, Baró MS, Moncayo FLG. Discriminación del malestar emocional en
pacientes oncológicos utilizando la escala de ansiedad y depresión hospitalaria (hads).
Ansiedad y Estres. 2009;15(2–3):217–29.
30. Vaganian L, Bussmann S, Gerlach AL, Kusch M, Labouvie H, Cwik JC. Critical
consideration of assessment methods for clinically significant changes of mental distress after
psychooncological interventions. Int J Methods Psychiatr Res. 2020;(January):1–7.
31. Weathers FW, Litz BT, Herman JA, Huska JA, Keane TM. The PTSD Checklist (PCL):
Reliability, validity and diagnostic utility. In: 9th Annual Conference of the ISTSS. San
Antonio, TX; 1993.
32. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders
[Internet]. (4th ed., text rev.). Washington, DC; 2000. 607–614 p. Available from:
https://linkinghub.elsevier.com/retrieve/pii/B0126574103004578
33. Costa-Requena G, Gil F. Posttraumatic stress disorder symptoms in cancer: psychometric
Page 15 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
16
analysis of the Spanish Posttraumatic Stress Disorder Checklist-Civilian version.
Psychooncology. 2010 May;19(5):500–7.
34. Tedeschi RG, Calhoun LG. The posttraumatic growth inventory: Measuring the positive
legacy of trauma. J Trauma Stress. 1996 Jan;9(3):455–71.
35. Costa-Requena G, Gil Moncayo FL. CRECIMIENTO POSTRAUMÁTICO EN PACIENTES
ONCOLÓGICOS. Análisis y Modif Conduct [Internet]. 2007 Jun 1;33(148):148. Available
from:
http://rabida.uhu.es/dspace/bitstream/handle/10272/5843/Crecimiento_postraumatico_en_paci
entes_oncologicos.pdf;sequence=2
36. James IA, Blackburn I-M, Reichelt, F K. Manual of the Revised Cognitive Therapy Scale
(CTSR). Newcastle Cogn Behav Ther [Internet]. 2001;431–46. Available from:
https://www.ed.ac.uk/files/atoms/files/ctsrmanual.pdf
37. Blackburn I, James IA, Milne DL, Reichelt FK, Garland A, Baker C, et al. Cognitive Therapy
Rating Scale for observers. 2000;(August).
38. Gasparini CD, Torres-Padrosa V, Boada I, Marzo JL. Videoconferencing in eHealth:
Requirements, integration and workflow. 2013 IEEE 15th Int Conf e-Health Networking,
Appl Serv Heal 2013. 2013;(Healthcom):201–6.
39. IBM Corporation. IBM SPSS Statistics for Windows, version 24.0. Armonk, NY: IBM Corp.;
2016.
40. Casellas-Grau A, Font A, Vives J. Positive psychology interventions in breast cancer. A
systematic review. Psychooncology [Internet]. 2014 Jan;23(1):9–19. Available from:
http://doi.wiley.com/10.1002/pon.3353
41. Freeman LW, White R, Ratcliff CG, Sutton S, Stewart M, Palmer JL, et al. A randomized trial
comparing live and telemedicine deliveries of an imagery-based behavioral intervention for
breast cancer survivors: Reducing symptoms and barriers to care. Psychooncology.
2015;24(8):910–8.
42. McGill BC, Sansom-Daly UM, Wakefield CE, Ellis SJ, Robertson EG, Cohn RJ. Therapeutic
Alliance and Group Cohesion in an Online Support Program for Adolescent and Young Adult
Cancer Survivors: Lessons from “recapture Life.” J Adolesc Young Adult Oncol.
2017;6(4):568–72.
43. Burm R, Thewes B, Rodwell L, Kievit W, Speckens A, Van De Wal M, et al. Long-term
Page 16 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
17
efficacy and cost-effectiveness of blended cognitive behavior therapy for high fear of
recurrence in breast, prostate and colorectal Cancer survivors: Follow-up of the SWORD
randomized controlled trial. BMC Cancer. 2019 May 16;19(1).
Page 17 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
18
Table 1. Baseline sociodemographic and clinical characteristics of participants
Statistics
PPC
(n= 145)
OPPC
(n= 124)
t
p
Age M (SD)
52.17 (8.36)
47.34 (8.05)
4.80
<.001
Civil status n (%)
.630
Single
7 (4.8)
9 (7.3)
Married
102 (70.3)
89 (71.8)
Divorced/Separated
25 (17.2)
19 (15.3)
Widow
9 (6.2)
7 (5.6)
Unknown
2 (1.4)
0 (0.0)
Education n (%)
.001
Primary
49 (33.8)
29 (23.4)
Secondary
57 (39.3)
52 (41.9)
Tertiary
27 (18.6)
42 (33.9)
Unknown
12 (8.3)
1 (0.8)
Work status n (%)
<.001
Passive
16 (11)
8 (6.5)
Active
11 (7.6)
24 (19.4)
Retired
24 (16.6)
22 (17.7)
Occupational disability
7 (4.8)
18 (14.5)
Work leave
73 (50.3)
49 (39.5)
Unknown
14 (9.7)
3 (2.4)
Psychiatric diagnosis n (%)
.324
Yes
115 (79.3)
89 (71.8)
No
26 (17.9)
29 (23.4)
Unknown
4 (2.8)
6 (4.8)
Oncological diagnosis n (%)
.648
Breast
118 (81.4)
101 (81.5)
Others
26 (17.9)
23 (18.5)
Unknown
1 (0.7)
0 (0.0)
Stage n (%)
.221
0
10 (6.9)
3 (2.4)
I
55 (37.9)
38 (30.6)
II
41 (28.3)
53 (42.7)
III
26 (17.9)
19 (15.3)
IV
7 (4.8)
5 (4.0)
N/A
1 (0.7)
1 (0.8)
Unknown
5 (3.4)
5 (4.0)
HADS M (SD)
Total
Anxiety
Depression
21.21 (7.26)
12.36 (4.10)
9.06 (4.25)
19.23 (7.31)
11.59 (4.06)
7.67 (4.38)
2.00
1.35
2.26
.047
.178
.025
PCL-CM (SD)
53.33 (12.95)
52.02 (12.81)
0.75
.454
PTGIM (SD)
50.04 (21.26)
52.32 (23.66)
-0.74
.459
Note. PPC = Positive Psychotherapy for Cancer; OPPC = Online Positive Psychotherapy for Cancer;
HADS = Hospital Anxiety and Depression Scales; PCL-C = Posttraumatic Stress Disorder Checklist-
Civilian version; PTGI = Posttraumatic Growth Inventory
Page 18 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
19
Table 2. Mean differences (95%CI) at post-treatment and follow-up with respect to baseline scores in all outcomes measured
Post-treatment
3-month follow-up
PPC
p
OPPC
p
PPC
p
OPPC
p
HADS total
-0.75 (-1.84 – 0.34)
.178
-1.57 (-2.61 – -0.53)
.003
-2.58 (-3.90 – -1.26)
<.001
-1.97 (-3.22 – -0.72)
.002
Anxiety
-0.45 (-1.14 – 0.20)
.170
-0.88 (-1.52 – -0.24)
.007
-1.32 (-2.17 – -0.47)
.002
-1.23 (-2.02 – -0.43)
.003
Depression
-0.21 (-0.93 – 0.52)
.573
-0.71 (-1.40 – -0.02)
.042
-1.12 (-1.91 – -0.33)
.006
-0.78 (-1.51 – -0.05)
.035
PCL-C
-0.55 (-2.52 – 1.41)
.579
-2.18 (-4.06 – -0.30)
.023
-2.60 (-5.10 – -0.10)
.042
-3.87 (-6.23 – -1.51)
.001
PTGI
5.35 (1.75 – 8.94)
.004
2.03 (-1.36 – 5.43)
.239
3.31 (-0.65 – 7.26)
.101
2.82 (-0.87 – 6.51)
.133
Note. PPC = Positive Psychotherapy for Cancer; OPPC = Online Positive Psychotherapy for Cancer; HADS = Hospital Anxiety and Depression
Scales; PCL-C = Posttraumatic Stress Disorder Checklist-Civilian version; PTGI = Posttraumatic Growth Inventory
Page 19 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
Figure 1. Consolidated standards of reporting trials (CONSORT) diagram.
Note. PPC = Positive Psychotherapy for Cancer; OPPC = Online Positive Psychotherapy for
Cancer
Analyzed (n = 145)
Completed follow-up (n = 99)
Lost to follow-up (n=13)
Preferred PPC intervention (n = 28)
Randomized to PPC intervention (n = 117)
Total allocated to PPC (n = 145)
Completed the treatment (n = 116)
Treatment dropouts (n = 29)
Did not start intervention (n = 21)
Started but not completed (n = 8)
Assessed for eligibility (n = 289)
Excluded (n = 20)
Not meeting inclusion criteria (n = 5)
Declined to participate (n = 15)
Analyzed (n = 124)
Preferred OPPC intervention (n = 16)
Randomized to OPPC intervention (n = 108)
Total allocated to OPPC (n = 124)
Completed the treatment (n = 99)
Treatment dropouts (n = 25)
Did not start intervention (n = 14)
Started but not completed (n = 11)
Completed follow-up (n = 116)
Lost to follow-up (n=37)
Allocation
Analysis
Follow-Up
Strong preference modality (n = 44)
Randomized (n = 225)
Enrollment
Page 20 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
Page 21 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For Peer Review
Figure 2. HADS total, PCL-C, and PTGI score means for PPC and OPPC at T0, T1 and T2
HADS
PCL-C
PTGI
Mean Score
Time
Time
Time
Note. PPC = Positive Psychotherapy for Cancer; OPPC = Online Positive Psychotherapy for Cancer; HADS = Hospital Anxiety and Depression
Scales; PCL-C = Posttraumatic Stress Disorder Checklist-Civilian version; PTGI = Posttraumatic Growth Inventory; T0=baseline,
T1=immediately after treatment; T2=three months after treatment
Page 22 of 54
http://mc.manuscriptcentral.com/pon
Psycho-Oncology
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
... Sample sizes ranged from 17 [25][26][27] to 325 [28] participants and interventions ranged from 2 weeks [29,30] to 6 months [31]. Neuropsychologists provided intervention in one trial [26], occupational therapists in six trials [25,30,[32][33][34][35], physiotherapists in twenty-six trials (30 reports) [27,29,30,32,34,, psychologists in seventeen trials (19 reports) [28,31,[61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77], and speech pathologists in five trials (7 reports) [78][79][80][81][82][83][84]. We did not identify trials comparing the delivery of podiatry interventions by telehealth with a face-to-face intervention. ...
... Web application (Garmin Connect) and heart rate monitor (Garmin Fore-runner 70) (Garmin™, Kansas, MO, USA) Duration = 12 weeks Not all telehealth interventions were delivered independently beyond the initial orientation period; five trials provided in-person support (from an assistant, volunteer, or technical support) with participants to assist with the use of technology and/or interventions [26,27,34], or at the remote clinic for technological troubleshooting or clinical emergencies (clinician or research coordinator) [73,74]. Whilst offering a comparable dose of intervention, some trials also included a mix of face-to-face sessions alongside telehealth; three included initial face-to-face session(s) [33,39,49], four trials included one to three face-to-face sessions for some or all trial participants [38,41,59,68] and the remainder offered weekly or bi-weekly face-to-face interventions [42,51]. [38,41,42]. ...
... Interventions delivered by psychologists using telehealth compared with face-to-face were investigated in seventeen trials (19 reports); [28,31,[61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77]. Most trials evaluated Cognitive Behavioral Therapy (CBT) or components of CBT [28,31,[62][63][64][65]69,[71][72][73]75,77], or Cognitive Processing Therapy (CPT) [61,67,70,76]. ...
Article
Full-text available
Objectives: To determine whether allied health interventions delivered using telehealth provide similar or better outcomes for patients compared with traditional face-to-face delivery modes. Study design: A rapid systematic review using the Cochrane methodology to extract eligible randomized trials. Eligible trials: Trials were eligible for inclusion if they compared a comparable dose of face-to-face to telehealth interventions delivered by a neuropsychologist, occupational therapist, physiotherapist, podiatrist, psychologist, and/or speech pathologist; reported patient-level outcomes; and included adult participants. Data sources: MEDLINE, CENTRAL, CINAHL, and EMBASE databases were first searched from inception for systematic reviews and eligible trials were extracted from these systematic reviews. These databases were then searched for randomized clinical trials published after the date of the most recent systematic review search in each discipline (2017). The reference lists of included trials were also hand-searched to identify potentially missed trials. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 1. Data Synthesis: Fifty-two trials (62 reports, n = 4470) met the inclusion criteria. Populations included adults with musculoskeletal conditions, stroke, post-traumatic stress disorder, depression, and/or pain. Synchronous and asynchronous telehealth approaches were used with varied modalities that included telephone, videoconferencing, apps, web portals, and remote monitoring, Overall, telehealth delivered similar improvements to face-to-face interventions for knee range, Health-Related Quality of Life, pain, language function, depression, anxiety, and Post-Traumatic Stress Disorder. This meta-analysis was limited for some outcomes and disciplines such as occupational therapy and speech pathology. Telehealth was safe and similar levels of satisfaction and adherence were found across modes of delivery and disciplines compared to face-to-face interventions. Conclusions: Many allied health interventions are equally as effective as face-to-face when delivered via telehealth. Incorporating telehealth into models of care may afford greater access to allied health professionals, however further comparative research is still required. In particular, significant gaps exist in our understanding of the efficacy of telehealth from podiatrists, occupational therapists, speech pathologists, and neuropsychologists. Protocol Registration Number: PROSPERO (CRD42020203128)
... Conversely, seven studies (Andrews et al., 2011;Aspvall et al., 2021;Mayor-Silva et al., 2021;Morland et al., 2011;Rosal et al., 2014;Serdar et al., 2014;Zerwas et al., 2017) are categorized with an overall "some concerns" risk of bias. On the other hand, six studies Gollings & Paxton, 2006;Hall et al., 2017;Lleras de Frutos et al., 2020;Morland et al., 2004;Paxton et al., 2007) are identified with a "high" overall risk of bias. ...
... Over 90% of the studies included adult participants, one evaluated young adults with an average age of over 19 years (Mayor-Silva et al., 2021), and one included children and adolescents with a mean age of 13.4 years (Aspvall et al., 2021). Over one-third of the sample was at least 85% female (Gollings & Paxton, 2006;Hall et al., 2017;Lleras de Frutos et al., 2020;Paxton et al., 2007;Rosal et al., 2014;Serdar et al., 2014;Zerwas et al., 2017). Over twothirds of the sample (n = 10) did not report data on race or ethnicity. ...
... Based on the selection criteria, 15 group treatments were included that compared, in the same study, a group intervention delivered in two delivery formats, online and F2F (Table 3). CBT was the targeted intervention model for 11 studies (CBT, CPT, or CBT-based therapies), one intervention was nutrition and exercise focused , another utilized positive psychology model (Lleras de Frutos et al., 2020), one study identified coping skills psychoeducation (Morland et al., 2004) while a final study offered dissonance-based prevention (Serdar et al., 2014). In 11 studies, manualized interventions were utilized, with eight referencing the manuals, as demonstrated in Table 3. Notably, four studies (Andrews et al., 2011;Clark et al., 2019;Hall et al., 2017;Mayor-Silva et al., 2021) did not specify the use of a manualized intervention. ...
Article
Full-text available
Purpose: Online group-based interventions are widely adopted, but their efficacy, when compared with similar face-to-face (F2F) psychosocial group interventions, has not been sufficiently examined. Methods: This systematic review included randomly controlled trials (RCTs) that compared an intervention/model delivered in both F2F and online formats. The review adhered to PRISMA guidelines and was registered with PROSPERO. Results: The search yielded 15 RCTs. Effect sizes ranged from small to exceptionally large. Between-condition effect sizes yielded nonsignificant differences in effectiveness except for three studies that reported superior effectiveness in outcomes for F2F interventions. High heterogeneity was found where only two studies integrated rigorous designs, thus limiting opportunity for a meta-analysis evaluation. Conclusions: Most studies showed comparable outcomes in both F2F and online modalities. However, given the heterogeneity of samples and outcomes, it is premature to conclude that online treatment is as effective as F2F for all challenges and populations.
... 19,20 and five studies obtained subject breast and other cancer sufferers. [21][22] The number of samples in the studies between 60-459 participants. 23,20 All studies included participants who were 18 years or older. ...
... Only one study reported some of their participants had primary education. 22 Four studies not informed the education level of their participants. The summary results of included studies are presented in Table 2. ...
... The majority of the studies used multiple videos as the educational tool (Table 3). However, three studies have utilize videoconferencing as a real-time communication as an additional 22,23 or sole educational 31 interventions. Further, not all studies determine the length of the videos, one study did not reported the video duration 19 , and one study did not describe the duration of videoconferencing. ...
Article
Full-text available
Background: Improving the education system of patient-centered health information is particularly important for vulnerable populations. The magnitude of the attributable breast cancer burden is very essential to be a concern to developing a good management strategy. Improving the patient’s understanding of their conditions may enhance the quality of life following breast cancer. The study aimed to review the effectiveness of audio-visual education through digital media platforms to improve the quality of life among people with breast cancer.Method: These 1643 articles from eight databases i.e., Scopus, PubMed, MEDLINE via EBSCO, the Cochran Library, Springer Link, Wiley Online Library, BioMed Central, and Sage Journals were searched by a combination of medical subject heading (MESH) term, and unique references were examined. All studies evaluating audio-visual education of women with breast cancer delivered by digital media platforms were included.Results: The search yielded 14 articles with various digital media platforms, such as web-based, applications, e-mail, videoconference, YouTube, and WhatsApp. All studies reported improving quality of life, except one study using WhatsApp as the platform. Audio-visual interventions were variably effective in enhancing the quality of life of patients depending on their characteristics. Audio-visual interventions appear to be effective in improving quality of life amongst breast cancer person. Nevertheless, its effectiveness depends on the frequency and intensity of audio-visual delivery. Meanwhile, the contents of education materials must be adjusted to the administration method. Audio-visual modeling via digital platforms may facilitate improving quality of life and can be an important consideration in future health-education interventions.
... The studies' characteristics are described below, and presented in Table 1. 46,50,55,64,68,70,75,76 seven in the USA, 24,39,42,43,52,60,69 four in Australia, 37,47,51,63 four in Canada, 34,44,53,73 three in South Korea, 38,71,72 three in Spain, [56][57][58] two in Iran, 33,45 one in the Netherlands, 65 one in Portugal, 61 one in Israel, 59 one in Germany, 49 one in Switzerland, 40 and one in Turkey. 32 Notably, one of the included studies was a dissertation 53 with the remaining being peer-reviewed publications. ...
... The 37 included studies covered a total of 46 interventions: Nine studies included more than one intervention arm, 24,34,37,42,44,56,58,65,72 four drew from the same theoretical model, 24 In addition, four trials adopted an existential framework. Two of them assessed meaning-centered interventions, that is, Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) 65 ; ...
... The risk of bias within the randomized controlled trials was assessed using the Cochrane Collaboration's Risk of Bias Tool. 22 Twenty-five out of the 37 studies were included in the risk of bias assessment for randomized controlled trials (see Figure 2); 17 of which were found to be at a high risk of bias, [32][33][34]37,45,46,51,52,56,58,61,64,65,68,73,75,76 while for eight the risk of bias was unclear. 24,42,47,49,50,[70][71][72] No study was at a low total risk of bias. ...
Article
Full-text available
Background It has been increasingly recognized that some people experience post‐traumatic growth (PTG) as a result of struggling with cancer. Objective This systematic review aims to identify psychosocial interventions that might facilitate PTG in adults with cancer. Methods A search was conducted in PsycINFO, PubMed, Scopus, the Cochrane Library, and ProQuest up to 16 September 2022. The PRISMA guidelines were followed; all included interventional studies had to comprise 30 or more adults with cancer, using the Posttraumatic Growth Inventory, from 1994 forward. Results A total of 2731 articles were retrieved, 1028 of those were screened and 37 unique trials were included (46 articles). A large number of studies were published since 2018 (52.4%), were randomized controlled trials (43.2%), and had group interventions (34.8%), including mainly female participants (83.8%) with a single cancer type (54.1%). Most interventions (75.7%) were moderately to highly effective in increasing PTG ( d = 0.65, 95% CI 0.39–0.91) with the most effective interventions using Cognitive Behavioral Therapy ( d = 1.24, 95% CI: 0.05–2.44), Mindfulness‐based ( d = 0.54, 95% CI = 0.14–0.94) and Education, Peer Support and Health Coaching interventions ( d = 0.28, 95% CI: 0.1–0.46). Expression‐based and Positive Psychology‐based approaches also showed promising results. Notably, the majority of studies had a high risk of bias. Conclusions PTG facilitation is a promising field that should be pursued as it not only allows people with cancer to overcome their trauma but also results in them going over and above their pre‐cancer state, enhancing resilience, health, and well‐being.
... As the control group did not experience any reduction in anxiety or improvement in quality of life, these positive changes are credited to the impact of the mobile phonebased continuous care model. These findings are consistent with previous research highlighting the benefits of educational interventions for cancer patients, delivered through various formats including group sessions, inperson meetings, or video formats [52][53][54]. ...
Article
Full-text available
Background Patients diagnosed with gynecological cancers often face a range of complications that can impact their quality of life and increase their anxiety. Nursing models combined with mobile phone applications have the potential to improve outcomes for these patients. This study aimed to assess the impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic cancer patients. Methods This study involved two phases: (1) mobile App development and (2) implementation of the intervention. The two-group randomized controlled trial included 70 participants with gynecological cancers referred to medical centers affiliated with Shahrekord University of Medical Sciences in 2023. The participants were randomized into control or intervention groups (n = 35 per group). Finally, 68 patients completed the trial. The intervention group received an 8-week intervention incorporating the continuous care model, whereas the control group received routine care (the standard support provided by nurses both during and after hospitalization). The participants completed the Spielberger state-trait anxiety and quality of life (QLQ-C30) questionnaires before, immediately after, and two months after the intervention. The data were analyzed via the chi-square test, independent samples t test, analysis of covariance, and repeated-measures ANOVA. Results There were no significant differences in the baseline data between the two groups. However, after the intervention, the intervention group reported a significant increase in quality of life, with mean scores rising from 68.90 ± 17.50 to 73.78 ± 16.79 immediately after the intervention and to 80.61 ± 9.90 at the two-month follow-up. In contrast, the control group showed no significant improvement. Additionally, state anxiety significantly decreased in the intervention group from 51.64 ± 14.97 to 40.20 ± 11.70 at the follow-up, and trait anxiety scores in the intervention group decreased significantly from 49.91 ± 14.96 to 39.82 ± 10.28 at the follow-up, whereas the scores of the control group worsened. Conclusion The intervention improved quality of life and reduced anxiety in patients with gynecological cancers. Given the scant attention given to mobile application-based follow-up in gynecologic cancer patients in previous studies, this approach can be incorporated into routine care to support patients, and it is recommended for nurses, health care providers, and physicians. Trial registration The study was registered as a randomized controlled trial in the Clinical Trial Registration Center of Iran. Registration Date: 2024-02-14, Registration Number: IRCT20231107059977N1.
... These findings of reduced bother from treatment side effects are consistent with cancer research comparing the effectiveness of face-to-face versus online groups involving a range of psychosocial interventions; e.g., cognitive behavior therapy, nutritional counseling, exercise programs [26]. In a recent study by Lleras de Frutos et al. (2020), for example, no significant differences were found between an in-person versus online group positive psychotherapy program in terms of sustained improvements in emotional distress and post-traumatic growth [28]. ...
Article
Full-text available
Although Androgen Deprivation Therapy (ADT) is effective in controlling prostate cancer (PCa) and increasing survival, it is associated with a myriad of side effects that cause significant morbidity. Previous research has shown that PCa patients starting on ADT are neither fully informed nor well-equipped to manage the breadth of ADT’s side effects. The ADT Educational Program (a 1.5 h interactive class plus a book) was developed as an evidence-based resource for patients dealing with ADT. Our aim here was to compare the efficacy of an online version of the class with a previously assessed in-person version of the class. Using mixed MANOVAs within a non-randomized comparison design, we assessed: (1) changes in patients’ experiences of self-efficacy to manage and bother associated with side effects approximately 10 weeks after attending a class, and (2) potential differences in these variables between online and in-person class formats. Side effect bother decreased from pre- to post-class but did not differ between in-person (n = 94) and online (n = 137) class cohorts. While self-efficacy to manage side effects was slightly higher post-class in both cohorts, the increase was not statistically significant. Average self-efficacy ratings were significantly higher among in-person versus online class participants (p < 0.05; ηp2 = 0.128). Both online and in-person classes are associated with a significant reduction in the severity of side effect bother reported by PCa patients, suggesting non-inferiority of online versus in-person formats. Online classes offer greater accessibility to the program for patients outside the reach of in-person classes, increasing the availability of the program to more PCa patients and family members across Canada.
... Repeated-measures ANOVA was used to compare the mean scores of state anxiety and trait anxiety in each group. showing the bene ts of educational interventions for cancer patients using group, in-person, or video methods [43][44][45]. ...
Preprint
Full-text available
Background and Aim Patients diagnosed with gynecological cancers often face a range of complications that can impact their quality of life and increase their anxiety. Nursing models combined with mobile phone applications have the potential to improve outcomes for these patients. This study aimed to assess the impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic cancer patients. Methods This study involved two phases: (1) mobile app development and (2) implementation of the intervention. The two-group randomized controlled trial included 70 participants with gynecological cancers referred to medical centers affiliated with Shahrekord University of Medical Sciences in 2023. The participants were randomized into control or intervention groups (n = 35 per group) on the basis of predetermined criteria, but during the study, there was one dropout in each group. Finally, 68 patients completed the trial. The intervention group received an 8-week intervention incorporating the continuous care model, whereas the control group received routine care. The participants completed the Spielberger state-trait anxiety and quality of life (QLQ-C30) questionnaires before, immediately after, and two months after the intervention. The data were analyzed via the chi-square test, independent samples t-test, analysis of covariance, and repeated-measures ANOVA. Results In the first phase, the mobile app was designed to meet patient requirements. In the second phase, the results revealed no significant differences in the baseline data between the two groups (P > 0.05). However, significant differences were observed immediately and two months after the intervention (P < 0.05). Intragroup comparisons in the intervention group revealed significant differences in trait anxiety, state anxiety, and quality of life before, immediately after and two months after the intervention (P < 0.05). Conclusion The intervention improved quality of life and reduced anxiety in patients with gynecological cancers. Therefore, this approach can be incorporated into routine care to support patients, and it is recommended for nurses, health care providers, and physicians. Trial registration The study was registered as a randomized controlled trial in the Clinical Trial Registration Center of Iran. Registration Date: 2024-02-14, Registration Number: IRCT20231107059977N1.
... Telemedicine has recently emerged as a key health care delivery strategy. Although prior work has demonstrated the utility of telemedicine in genetic counseling, 1-7 survivorship, 8,9 and risk reduction initiatives such as smoking cessation, 10 there are limited data regarding the impact of telemedicine on advance care planning and acute care utilization among patients at risk for near-term mortality ("high-risk"). In this population, advance care planning, which consists of discussions about prognosis, goals of care, and priorities at the end of life, has become a quality standard in oncology care. ...
Article
Full-text available
Background Despite the widespread implementation of telemedicine, there are limited data regarding its impact on key components of care for patients with incurable or high‐risk cancer. For these patients, high‐quality care requires detailed conversations regarding treatment priorities (advance care planning) and clinical care to minimize unnecessary acute care (unplanned hospitalizations). Whether telemedicine affects these outcomes relative to in‐person clinic visits was examined among patients with cancer at high risk for 6‐month mortality. Methods This retrospective cohort study included adult patients with cancer with any tumor type treated at the University of Pennsylvania who were newly identified between April 1 and December 31, 2020, to be at high risk for 6‐month mortality via a validated machine learning algorithm. Separate modified Poisson regressions were used to assess the occurrence of advance care planning and unplanned hospitalizations for telemedicine as compared to in‐person visits. Additional analyses were done comparing telemedicine type (video or phone) as compared to in‐person clinic visits. Results The occurrence of advance care planning was similar between telemedicine and in‐person visits (6.8% vs. 6.0%; adjusted risk ratio [aRR], 1.25; 95% CI, 0.92–1.69). In regard to telemedicine subtype, patients exposed to video encounters were modestly more likely to have documented advance care planning in comparison to those seen in person (7.5% vs. 6.0%; aRR, 1.48; 95% CI, 1.03–2.11). The 3‐month risk for unplanned hospitalization was comparable for telemedicine compared to in‐person clinic encounters (21% vs. 18%; aRR, 1.06; 95% CI, 0.81–1.38). Conclusions In this study, care delivered by telemedicine, compared to in‐person clinic visits, produced comparable rates of advance care planning conversations without increasing hospitalizations, which suggests that vulnerable patients can be managed safely by telemedicine.
Article
Modern cancer care is costly and logistically burdensome for patients and their families despite an expansion of technology and medical advances that create the opportunity for novel approaches to care. Therefore, there is a growing appreciation for the need to leverage these innovations to make cancer care more patient centered and convenient. The Memorial Sloan Kettering Making Telehealth Delivery of Cancer Care at Home Efficient and Safe Telehealth Research Center is a National Cancer Institute–designated and funded Telehealth Research Center of Excellence poised to generate the evidence necessary to inform the appropriate use of telehealth as a strategy to improve access to cancer services that are convenient for patients. The center will evaluate telehealth as a strategy to personalize cancer care delivery to ensure that it is not only safe and effective but also convenient and efficient. In this article, we outline this new center’s research strategy, as well as highlight challenges that exist in further integrating telehealth into standard oncology practice based on early experiences.
Preprint
Full-text available
Purpose we investigate (a) the diffusion of digital solutions supporting the quality of life in cancer patients and their caregivers across cancer types and EU countries, (b) the key thematic areas on which they focus, and (c) their effectiveness in improving the quality of life with respect to traditional healthcare. Methods We searched articles from Embase, Scopus and PubMed in the last decade, and assessed their quality according to mixed methods appraisal tool. We compared the effectiveness of such tools and discussed the main gaps that emerged. Results 49 studies were included (31 quantitative randomized control trials, 9 quantitative non-randomized, 4 quantitative descriptive, 3 qualitative, and 2 mixed-methods). We observed a prevalence of studies from the Netherlands and Germany, and breast cancer patients are the most targeted by single-cancer type interventions. The key areas of interventions for e-health solutions are psychophysical well-being, management of physical distress, remote monitoring of vitals and symptoms, and empowerment and self-efficacy. The effectiveness of digital solutions is typically higher than traditional healthcare, especially for solutions focusing on psychosocial well-being. Conclusions This review showed a growing interest in digital solutions aimed at making the life of cancer patients and their caregivers easier, and their healthcare more patient-centered. The effectiveness of such interventions varies, but all the solutions are well accepted among the participants. Our findings provide evidence of the untapped potential of these digital tools, and of the need for their integration in the daily routine of cancer patients and their caregivers.
Article
Full-text available
Objectives Considering the heterogeneity of cancer entities and the associated disease progression, personalized care of patients is increasingly emphasized in psycho‐oncology. This individualization makes the use of measurements of individual clinically significant change important when studying the efficacy and effectiveness of psycho‐oncological care. Two conceptualizations for the measurement of clinical significance are critically contrasted in this study: the Reliable Change Index (RCI) and the Minimal Important Difference (MID) method. Methods In total, 2,121 cancer patients participated in the study and a subsample of 708 patients was reassessed about 4 months later. Psychological distress was measured using the Hospital Anxiety and Depression Scale. We evaluated two measures of clinical significance (RCI, MID) by comparing the respective numbers of improved, unimproved, and deteriorated patients. Results Individually significant changes were observed with both methods; however, determined rates of improvement differed substantially: MID (66.67%) and RCI (48.23%). Most importantly, according to MID, 17.93% of patients were identified as being improved, although their respective improvements were not statistically significant and thus unreliable. Conclusions The benefits of RCI outweigh MID, and therefore, the RCI is recommended as a measure to assess change.
Article
Full-text available
PURPOSE Fear of cancer recurrence (FCR) is a significantly distressing problem that affects a substantial number of patients with and survivors of cancer; however, the overall efficacy of available psychological interventions on FCR remains unknown. We therefore evaluated this in the present systematic review and meta-analysis. METHODS We searched key electronic databases to identify trials that evaluated the effect of psychological interventions on FCR among patients with and survivors of cancer. Controlled trials were subjected to metaanalysis, and the moderating influence of study characteristics on the effect were examined. Overall quality of evidence was evaluated using the GRADE system. Open trials were narratively reviewed to explore ongoing developments in the field (PROSPERO registration no.: CRD42017076514). RESULTS A total of 23 controlled trials (21 randomized controlled trials) and nine open trials were included. Small effects (Hedges’s g) were found both at postintervention (g = 0.33; 95% CI, 0.20 to 0.46; P,.001) and at followup (g = 0.28; 95% CI, 0.17 to 0.40; P , .001). Effects at postintervention of contemporary cognitive behavioral therapies (CBTs; g = 0.42) were larger than those of traditional CBTs (g = 0.24; b = .22; 95% CI, .04 to .41; P = .018). At follow-up, larger effects were associated with shorter time to follow-up (b = 2.01; 95% CI, 2.01 to 2.00; P = .027) and group-based formats (b = .18; 95% CI, .01 to .36; P = .041). A GRADE evaluation indicated evidence of moderate strength for effects of psychological intervention for FCR. CONCLUSION Psychological interventions for FCR revealed a small but robust effect at postintervention, which was largely maintained at follow-up. Larger postintervention effects were found for contemporary CBTs that were focused on processes of cognition—for example, worry, rumination, and attentional bias—rather than the content, and aimed to change the way in which the individual relates to his or her inner experiences. Future trials could investigate how to further optimize and tailor interventions to individual patients’ FCR presentation.
Article
Full-text available
Objectives Online resources are changing patient‐professional relationship and care delivery by empowering patients to engage in decisions in order to cope with their illness and modify behaviors. This review analyses the psychological factors associated with spontaneous and health professional–guided internet use in cancer patients. Methods Searches were performed in the PubMed (MEDLINE), PsycINFO, and Scopus databases. Studies were included if they involved cancer patients or focused on the relationship between cancer patients and health professionals, describing either patients' spontaneous use of interne or a guided‐structured eHealth psychosocial intervention. Results Seventy‐seven scientific papers were finally included. Results described emotional and behavioral outcomes in cancer patients who accessed online information. Internet has long been used spontaneously not only as a source of medical information or symptom management but also for decision making or emotional and social support. Health professionals can guide internet use, providing specific web‐based recommendations and developing intervention programs to better meet patients' needs, such as educational or information programs. Conclusion Online access is a complementary form of care that physicians can provide. Patients benefit from online resources, especially when both they and their health professionals increase their engagement with online interventions such as integrated systems or online communities.
Article
Full-text available
Background: To overcome the lag with which cancer statistics become available, we predicted numbers of deaths and rates from all cancers and selected cancer sites for 2019 in the European Union (EU). Materials and methods: We retrieved cancer death certifications and population data from the World Health Organization and Eurostat databases for 1970-2014. We obtained estimates for 2019 with a linear regression on number of deaths over the most recent trend period identified by a logarithmic Poisson joinpoint regression model. We calculated the number of avoided deaths over the period 1989-2019. Results: We estimated about 1 410 000 cancer deaths in the EU for 2019, corresponding to age-standardized rates of 130.9/100 000 men (-5.9% since 2014) and 82.9 women (-3.6%). Lung cancer trends in women are predicted to increase 4.4% between 2014 and 2019, reaching a rate of 14.8. The projected rate for breast cancer was 13.4. Favourable trends for major neoplasms are predicted to continue, except for pancreatic cancer. Trends in breast cancer mortality were favourable in all six countries considered, except Poland. The falls were largest in women 50-69 (-16.4%), i.e. the age group covered by screening, but also seen at age 20-49 (-13.8%), while more modest at age 70-79 (-6.1%). As compared to the peak rate in 1988, over 5 million cancer deaths have been avoided in the EU over the 1989-2019 period. Of these, 440 000 were breast cancer deaths. Conclusion: Between 2014 and 2019, cancer mortality will continue to fall in both sexes. Breast cancer rates will fall steadily, with about 35% decline in rates over the last three decades. This is likely due to reduced hormone replacement therapy use, improvements in screening, early diagnosis and treatment. Due to population ageing, however, the number of breast cancer deaths is not declining.
Article
Full-text available
Background Blended cognitive behaviour therapy (bCBT) is an effective treatment for fear of cancer recurrence (FCR) in curatively-treated breast, colorectal and prostate cancer survivors with high FCR. However, long-term outcomes are unknown. This study investigated the long-term efficacy and cost-effectiveness of bCBT compared with care as usual (CAU). Methods Eighty-eight cancer survivors with high FCR (Cancer Worry Scale ≥14) were randomly assigned to bCBT (n = 45) or CAU (n = 43). Data were collected at baseline and at three, nine and fifteen months from baseline and analysed by modified intention-to-treat. Efficacy was investigated with linear mixed-effects models. Cost-effectiveness was investigated from a societal perspective by comparing costs with quality-adjusted life-years (QALYs). Results Participants who received bCBT reported significantly lower FCR compared with CAU (mean difference of − 1.787 [95% CI -3.251 to − 0.323, p = 0.017] at 15 months follow-up), and proportionally greater self-rated and clinically significant improvement at each follow-up measurement. Total QALYs were non-significantly different between conditions when adjusted for utility score baseline differences (0.984 compared to 0.957, p = 0.385), while total costs were €631 lower (95% CI -1737 to 2794, p = 0.587). Intervention costs of bCBT were €466. The incremental cost-effectiveness ratio amounted to an additional €2049 per QALY gained, with a 62% probability that bCBT is cost-effective at a willingness to pay (WTP) threshold of €20,000 per QALY. Results were confirmed in sensitivity analyses. Conclusions bCBT for cancer survivors with FCR is clinically and statistically more effective than CAU on the long-term. In addition, bCBT is a relatively inexpensive intervention with similar costs and QALYs as CAU. Trial registration The RCT was registered in the Dutch National Trial Register (NTR4423) on 12-Feb-2014. This abstract was previously presented at the International Psycho-Oncology Society conference of 2018 and published online. (Psycho-oncology, 27(S3):8-55; 2018) Electronic supplementary material The online version of this article (10.1186/s12885-019-5615-3) contains supplementary material, which is available to authorized users.
Article
Full-text available
Purpose: Unmanaged distress has been shown to adversely affect survival and quality of life in breast cancer survivors. Fortunately, distress can be managed and even prevented with appropriate evidence-based interventions. Therefore, the objective of this systematic review was to synthesize the published literature around predictors of distress in female breast cancer survivors to help guide targeted intervention to prevent distress. Methods: Relevant studies were located by searching MEDLINE, Embase, PsycINFO, and CINAHL databases. Significance and directionality of associations for commonly assessed candidate predictors (n ≥ 5) and predictors shown to be significant (p ≤ 0.05) by at least two studies were summarized descriptively. Predictors were evaluated based on the proportion of studies that showed a significant and positive association with the presence of distress. Results: Forty-two studies met the target criteria and were included in the review. Breast cancer and treatment-related predictors were more advanced cancer at diagnosis, treatment with chemotherapy, longer primary treatment duration, more recent transition into survivorship, and breast cancer recurrence. Manageable treatment-related symptoms associated with distress included menopausal/vasomotor symptoms, pain, fatigue, and sleep disturbance. Sociodemographic characteristics that increased the risk of distress were younger age, non-Caucasian ethnicity, being unmarried, and lower socioeconomic status. Comorbidities, history of mental health problems, and perceived functioning limitations were also associated. Modifiable predictors of distress were lower physical activity, lower social support, and cigarette smoking. Conclusions: This review established a set of evidence-based predictors that can be used to help identify women at higher risk of experiencing distress following completion of primary breast cancer treatment.
Article
Full-text available
Purpose Fear of cancer recurrence (FCR) is a common problem experienced by cancer survivors. Approximately one third of survivors report high FCR. This study aimed to evaluate whether blended cognitive behavior therapy (bCBT) can reduce the severity of FCR in cancer survivors curatively treated for breast, prostate, or colorectal cancer. Patients and Methods This randomized controlled trial included 88 cancer survivors with high FCR (Cancer Worry Scale score ≥ 14) from 6 months to 5 years after cancer treatment. Participants were randomly allocated (ratio 1:1, stratified by cancer type) to receive bCBT, including five face-to face and three online sessions (n = 45) or care as usual (CAU; n = 43). Participants completed questionnaires at baseline (T0) and 3 months later (T1). The intervention group completed bCBT between T0 and T1. The primary outcome was FCR severity assessed with the Cancer Worry Scale. Secondary outcomes included other distress-related measures. Statistical (one-way between-group analyses of covariance) and clinical effects (clinically significant improvement) were analyzed by intention to treat. Results Participants who received bCBT reported significantly less FCR than those who received CAU (mean difference, –3.48; 95% CI, –4.69 to –2.28; P < .001) with a moderate-to-large effect size ( d = 0.76). Clinically significant improvement in FCR was significantly higher in the bCBT group than in the CAU group (13 [29%] of 45 compared with 0 [0%] of 43; P < .001); self-rated improvement was also higher in the bCBT group (30 [71%] of 42 compared with 12 [32%] of 38 in the CAU group; P < .001). Conclusion bCBT has a statistically and clinically significant effect on the severity of FCR in cancer survivors and is a promising new treatment approach.
Article
This randomized controlled trial compared the efficacy of cognitive behavioral stress management (CBSM) and positive psychotherapy in cancer (PPC) to reduce post-traumatic stress symptoms (PTSS) and distress, and to promote post-traumatic growth (PTG) in cancer survivors. Participants were 140 adult women randomly allocated to CBSM (n = 73) or PPC (n = 67). PTSS, distress, and PTG were assessed at pre-and post-intervention, and at 3-and 12-month follow-ups. Analysis showed PPC was more effective in decreasing PTSS (b = −7.61, p <.001) and distress (b = −3.66; p <.001) than CBSM, but neither therapy significantly increased PTG (b = 0.77, p = .76). The relational veracity of PTG and its role predicting reduced PTSS was observed only in the PPC arm. In conclusion, PPC appears to be a valid therapeutic option for assimilating and accommodating the experience of cancer after treatment completion.
Article
Objective Online psychological therapies provide a way to connect adolescent and young adult (AYA) cancer survivors to evidence‐based support. We aimed to establish the feasibility, acceptability, and safety of Recapture life, a six‐session group‐based online cognitive‐behavioural intervention, led by a facilitator, for AYAs in the early post‐treatment period. Methods A randomised‐controlled trial (RCT) compared Recapture Life to an online peer‐support group control and a waitlist control. Participants could nominate a support person. Acceptability was assessed using study opt‐in and retention rates, participant‐reported benefits/burdens of participation, and group facilitator burden. We also assessed the feasibility (e.g.,‐frequency/impact of technological difficulties) and psychological safety (i.e.,‐occurrence of clinically‐concerning distress) of the program. Results Sixty‐one participants took part (45 AYAs, 51.1% female;‐19 support people). The opt‐in rate was 30%, the enrolment rate was 87%, and 75% of participants took part in ≥5/6 sessions. AYAs reported high benefit and low burden of participation. Overall, 95 online group sessions were conducted; few required rescheduling by group facilitators (3%), but many took place outside of office‐hours (~90 hours). It took 40 days on average to create online groups, but established weekly sessions commenced quickly (M=4.0 minutes). Technological difficulties were common but had a low impact on intervention delivery. Although 54% of AYAs returned a clinically‐concerning distress screen at some point, none reflected acute mental health risks. Conclusions The data largely indicates that Recapture Life is an acceptable, feasible, and safe model of evidence‐based psychological support for AYAs during early survivorship, that nevertheless experienced common challenges in online/AYA intervention delivery.
Article
Psychological support services for adolescent and young adults (AYAs) with cancer are moving online and are increasingly peer based. It is unclear whether online service delivery impacts critical therapeutic elements such as collaborative patient-therapist rapport and group cohesion. AYA cancer survivors (N = 39) participating in a six-week online cognitive-behavioral therapy group program-"Recapture Life"-rated their perception of therapeutic alliance and group cohesion. Participant-rated alliance and group cohesion were high throughout the program, and therapist-rated participant openness, trust, and motivation strengthened over time. The findings provide further support for the expansion of AYA cancer support services to the online domain.