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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
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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
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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-
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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
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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
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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-off 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
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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]
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= 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
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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
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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
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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.
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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
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4
5
6
7
8
9
10
11
12
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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
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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
psycho‐oncological 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
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60
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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
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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).
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Table 1. Baseline sociodemographic and clinical characteristics of participants
Statistics
PPC
(n= 145)
OPPC
(n= 124)
t
X2
p
Age M (SD)
52.17 (8.36)
47.34 (8.05)
4.80
<.001
Civil status n (%)
2.58
.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 (%)
16.39
.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 (%)
22.76
<.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 (%)
2.25
.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 (%)
0.87
.648
Breast
118 (81.4)
101 (81.5)
Others
26 (17.9)
23 (18.5)
Unknown
1 (0.7)
0 (0.0)
Stage n (%)
8.24
.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
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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
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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
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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
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