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Rationale and Protocol of CML Study: Cognitive and Emotional Impact of Discontinuation of Therapy in Patients with Chronic Myeloid Leukemia

  • St Mary's University,Twickenham London
  • IEO - Istituto Europeo di Oncologia - and University of Milan


Introduction: Discontinuation of therapy can be proposed to patients with chronic myelogenous leukemia (CML) who reach a sustained deep molecular response (DMR) for a minimum and stable period. Today, a considerable number of patients reach a sustained DMR, especially when they are treated with the latest drugs. Although new-generation treatments may provide significant improvement in terms of patient health and health-related quality of life, many patients are uncertain about discontinuation and may refuse a treatment switch. Methods: This study is an observational research project aimed at investigating, from a psychological point of view, possible cognitive and emotional components that can influence treatment discontinuation and treatment decisions in a cohort sample of 120 CML patients. Results: The expected results indicate that cognitive and emotional factors may influence decision-making in this setting and may prevent appropriate risk-and-benefit evaluation of new treatment approaches. Conclusions: This is the first study that will analyze in depth all possible psychological variables that can interfere with the medical decision process of treatment discontinuation in CML, providing new insights for clinical practice.
© 2015 INTM, Italy. Published by Wichg Publishing
ISSN 0300-8916
Tumori 2016; 102(2): 217-221
cells, but treatment can help achieve long-term remission
(3). In some paents, however, treatment appears to eec-
vely induce complete disease remission (4). In such cases,
disconnuaon of therapy may be an opon under certain
Disconnuaon of therapy can be proposed to CML
paents who reach a sustained deep molecular response
(DMR) for a minimum and stable period (normally 2 years)
(5). However, the choice may represent a considerable
challenge to paents, and not only clinical but also psycho-
logical and emoonal factors may inuence the medical
decision-making process. Emoonal and cognive aspects
can impact on medical choices, thereby interfering with
treatment, coping, risk evaluaon and paent-doctor rela-
onships, as shown in previous work by our group (6-10).
In this process, paents are asked to comtemplate a major
change in their usual treatment and this change can sig-
nicantly impact everyday-life acvies and health-related
quality of life (HRQL). For this reason, current scienc dis-
cussions on therapy and clinical trials are evaluang when
and how to propose the disconnuaon of TKI therapy
Currently only a small percentage of paents switch
to the new opon, while the majority prefer to connue
with the usual treatment even when blood tests reveal a
DOI: 10.5301/tj.5000451
Raonale and protocol of CML study: cognive and
emoonal impact of disconnuaon of therapy in
paents with chronic myeloid leukemia
Silvia Riva1,2, Ke Mazzocco1,2, Gabriella Praveoni1,2
1 Department of Oncology and Hemato-oncology, University of Milan, Milan - Italy
2 Applied Research Division for Cognive and Psychological Science, European Instute of Oncology (IEO), Milan - Italy
Over the past decade, dierent types of drugs designed
to specically inhibit protein tyrosine kinases (tyrosine kinase
inhibitors or TKIs) have become a new treatment for cancer
paents, and the example of chronic myeloid leukemia (CML)
is one of the most resounding (1). In this disease, TKIs have
dramacally improved the long-term survival rate (95.2%) (2)
and they are now rmly established as an eecve therapy
for paents with CML (3).
Today, the most favorable outcome in CML treatment is
to eliminate the blood cells that contain the abnormal BCR-
ABL gene causing the overabundance of diseased blood cells.
In most paents it is not possible to eliminate all diseased
Introducon: Disconnuaon of therapy can be proposed to paents with chronic myelogenous leukemia (CML)
who reach a sustained deep molecular response (DMR) for a minimum and stable period. Today, a considerable
number of paents reach a sustained DMR, especially when they are treated with the latest drugs. Although new-
generaon treatments may provide signicant improvement in terms of paent health and health-related quality
of life, many paents are uncertain about disconnuaon and may refuse a treatment switch.
Methods: This study is an observaonal research project aimed at invesgang, from a psychological point of
view, possible cognive and emoonal components that can inuence treatment disconnuaon and treatment
decisions in a cohort sample of 120 CML paents.
Results: The expected results indicate that cognive and emoonal factors may inuence decision-making in this
seng and may prevent appropriate risk-and-benet evaluaon of new treatment approaches.
Conclusions: This is the rst study that will analyze in depth all possible psychological variables that can inter-
fere with the medical decision process of treatment disconnuaon in CML, providing new insights for clinical
Keywords: Chronic myeloid leukemia, Decision-making, Disconnuaon, Medical choices, Personality, Risk
Accepted: October 20, 2015
Published online: December 11, 2015
Corresponding author:
Silvia Riva
Department of Health Sciences
University of Milan
Via A. Di Rudinì 8
20142 Milan, Italy
Raonale and protocol of CML study
© 2015 INTM, Italy. Published by Wichg Publishing
complete and stable remission of CML (14-16). However,
connuing therapy may no longer be appropriate in terms
of cost-eecveness, both from a welfare and paent per-
specve (12, 13). In fact, the prescripon of TKIs may weigh
on public health expenses. Moreover, the standard therapy
undoubtedly has an impact on paents’ HRQL in terms of
compliance with treatment and of the nontrivial side eects
of the drugs (17, 18). Nevertheless, the most eecve way
to support paents across this change has only marginally
been addressed (15, 17).
It is therefore crical to invesgate the risk atude
that could inuence the choices and decisional processing
of paents eligible to switch and/or disconnue therapy.
In this context, evaluang the psychological prole of CML
paents including personality traits, emoonal and cogni-
ve funcons can shed light on the factors that impact on
their risk atude and its inuence on treatment choice.
More specically, the atude toward risk behaviors, risk
percepon, and personality traits may reveal crical pieces
of informaon that subtend the willingness or rejecon to
switch to second-generaon TKIs and/or disconnuaon of
Such informaon will be very useful to all clinicians who
treat paents with CML because it will make it clear which
type of paents can be proposed a switch to second-gener-
aon drugs and/or disconnuaon of therapy and how they
can be supported in this change.
Study objecves
The primary objecve of this study is to dene the risk
prole of CML paents at dierent stages of the disease using
the following measures:
patients’ risk attitude
patients’ risk preferences
patients’ need for cognitive closure
patients’ personality traits
The secondary objectives of this study are to assess which
determinants affect the risk profile, including
patient history
clinical parameters (e.g., diagnosis, treatment, status of
the disease)
sociodemographic data (e.g., age, gender)
Study design
The study follows the STROBE (STrengthening the
Reporng of OBservaonal studies in Epidemiology) guide-
lines for observaonal studies and will adhere to the
STROBE checklist for cohort, case-control, and cross-seconal
studies (19).
This is a prospecve, non-intervenonal study (NIS) that
will describe the risk prole in CML paents with dierent
types of treatment and responses. The study is focused
on adults (>18 years of age) living in Italy. The NIS will be
coordinated in Milan at the Psycho-Oncology Unit of the
European Instute of Oncology (IEO), Milan, Italy. However,
also other Italian centers included in the Lombardy Hemato-
logical Network (Rete Ematologica Lombarda - hp://www. will be asked to parcipate in data col-
lecon under the supervision of the center in Milan. It is
expected that data from approximately 120 paents will be
The study period will last 12 months. The rst 2 months
will be used for the regulatory process with approval of the
study protocol in all parcipang centers.
Premature disconnuaon of data capture
Paents will be followed as long as data from roune
assessments are available and the permission to document
the data has not been withdrawn. If a paent cannot be
followed, the reasons for this will be entered into the docu-
mentaon form.
Design and me frames
In this prospecve study, risk proles will be assessed
over a 12-month period in a cohort of adult CML paents
who are receiving roune medical care. In order to inves-
gate the individual cognive and psychological proles with
parcular aenon to the personal risk atude of paents,
each paent will be asked to parcipate in a 1-hour tesng
session that will take place in a hospital room assigned for
this purpose. The session will be conducted by sta who
have been specically trained by one of the authors of this
paper (GP), a trained cognive psychologist who is an ex-
pert in cognive and psychological assessment.
CML paents with dierent types of treatment and respons-
es as dened in Table I according to the European LeukemiaNet
guidelines of 2013 (5) will be included in this NIS.
Inclusion criteria
CML patients with one of the characteristics described in
Table I
Age >18 years
Ability to read and understand the study materials (pa-
tient information and data protection form, patient-related
Signed data protection form
Exclusion criteria
The following paents will not be included in the study:
Patients affected by neurological and/or severe psychiat-
ric disorders (i.e., patients suffering from psychosis and/
or personality disorders)
Patients with mild cognitive impairment
Patients treated with drugs other than TKIs
Riva et al 219
© 2015 INTM, Italy. Published by Wichg Publishing
Variables assessed
Dierent types of variables will be assessed in the frame-
work of the current study including risk atude, risk prefer-
ences, cognive variables and personality traits related to risk,
as well as informaon about sociodemographic and clinical
data. Most of the variables will be derived from validated
All quesons will be presented in a paent booklet for
each single paent. Administraon of the quesonnaire will
take about 20 minutes per paent.
Measures of psychological aributes, risk atude, risk
preferences and need for cognive closure
The ALGA quesonnaire
ALGA is a quesonnaire developed to invesgate dierent
psychological areas and is mainly aimed at creang a paent
prole that can help physicians and other health-care provid-
ers to beer interact with paents (20). In this quesonnaire,
the 3 macro-areas under consideraon are (a) cognive, (b)
physical-related and (c) psychological, all invesgated in dif-
ferent subdimensions.
The benets of the ALGA paent proles are many:
improved information delivery to the patient: with the
help of a graphical summary of the patient profile, doc-
tors can adjust the content and the level of verbal in-
formation to the patient’s perceived needs and level of
identification of important trials for enrolment: besides
being used to adjust the information provided, the patient
profile can also enable automatic identification of possible
clinical trials in which the patient could be enrolled. His/
her clinical information is compared against the eligibility
criteria of several trials and possible matches are identified.
This matching uses advanced algorithms over a semanti-
cally enriched clinical trial repository.
The Smulang-Instrumental Risk Inventory (SIRI)
The SIRI enables in-depth analysis of 2 characteriscs of risk-
taking behavior: (i) smulang risk taking (SRT), which is uncon-
trollable, impulsive, unconcerned with the magnitude of poten-
al losses, and dominated by emoonal processes and posive
arousal; it emphasizes potenal gains and focuses on the short
term; (ii) instrumental risk taking (IRT), which is controllable,
reecve, concerned with the magnitude of potenal losses,
and dominated by cognive processes and negave arousal; it
emphasizes potenal losses and focuses on the long term (21).
The quesonnaire comprises 17 items and uses 4-point rangs
(1 = does not describe me at all to 4 = describes me very well).
The Need for (Cognive) Closure Scale (NFCS)
The need for closure reects the desire for “an answer on
a given topic, any answer, as compared to confusion and am-
biguity” (22). A person characterized by a high need for closure
needs an immediate resoluon of the problem. The search for a
soluon makes the person hypervigilant and somemes panick-
ing looking for a soluon and tends to give the choice respon-
sibility to others. The need for cognive closure aects what
informaon individuals seek out, and how they process such
informaon to make a decision. The quesonnaire comprises
42 items and uses 6-point rangs (1 = strongly disagree to 6 =
strongly agree). The scale includes 5 subscales pertaining to
desire for predictability
preference for order and structure
discomfort with ambiguity
The Passive Risk Taking Scale (PRT)
The PRT measures the “passive risk” – risk brought on or
magnied by inacon. We dene passive risk taking as fore-
going an opportunity to act in order to reduce outcome vari-
ance (23). The quesonnaire is composed of 25 items and
uses a 7-point rang scale indicang to what extent people
are likely to behave in the manner described in each item. It
measures 3 subscales:
risks that involve resources
risks that involve medical issues
risks that involve ethical issues
Measures of personality traits related to risk
The Resistance to Change (RTC) quesonnaire
The RTC is a personality quesonnaire specically focused
on evaluang traits related to risk. “Resistance to change”
can be dened as the acon taken by individuals when they
perceive a change that is occurring as a threat to them (24).
Therefore, the quesonnaire was designed to assess individu-
als’ tendencies “to resist or avoid making changes, to devalue
change generally, and to nd change aversive across diverse
contexts and types of change” (24).
TAbLE I - Hematological characteriscs of paents included in the
Type of response Denion
MCyR Major cytogenec
0-35% Ph+ marrow
CCyR Complete cy togenec
0% Ph+ marrow
MMR Major molecular
≤0.1% (IS)
MR4.0 BCR-ABL/ABL <0.01%
(IS) “4-log reducon”
MR4.5 or more BCR-ABL/ABL <0.003%
(IS) “4.5-log reducon”
IS = internaonal scale; MR = molecular response; Ph+ = Philadelphia chro-
mosome posive.
Raonale and protocol of CML study
© 2015 INTM, Italy. Published by Wichg Publishing
The quesonnaire is composed of 17 items and uses
6-point rangs (1 = strongly disagree to 6 = strongly agree). It
measures 4 subscales pertaining to
routine seeking (RS): the behavioral component of
resistance to change, “the inclination to adopt rou-
emotional reaction (ER): the affective component of re-
sistance to change, “the amount of stress and uneasi-
ness” induced by change
short-term focus (SF): the affective component of re-
sistance to change, “the extent to which individuals are
distracted by the short-term inconveniences” associated
with change
cognitive rigidity (CR): the cognitive component of resis-
tance to change, “frequency and ease with which people
change their minds”
Addional parameters
Addional variables will be assessed with regard to dif-
ferent parameters such as paent history and will be col-
lected by health-care professionals (8 quesons). A set of
ad hoc items (7 closed quesons) will be developed in or-
der to analyze the paent’s knowledge of and preferences
about the disease: diagnosis, treatment, and disease status.
Finally, clinical and sociodemographic data will be collected
as described in Table II. Regular appointments are expected
to be performed at the medical center, starng with the
appointment where the paent’s wrien consent to data
collecon is obtained.
The paent idener consists of 2 parts by which the
paents will be uniquely idened: (i) the center (2 digits),
and (ii) the paent idencaon number within the center
(2 numbers). Each center will be provided with a parcipa-
on list where each enrolled paent will be consecuvely
Stascal analysis
Sample size determinaon
This study is an NIS and the stascal approach is explor-
atory in nature. A sample size of 120 paents aged >18 has
been esmated. This sample size was chosen on the basis of
the following consideraons:
1. The available literature on discontinuation of therapy in
CML patients is very limited.
2. In the absence of preliminary data, sample size criteria
will be based on subjective experience.
3. A sample size of 120 patients seems to be reasonable
in view of the fact that no dropout is to be considered
as this is a cross-sectional study. It has to be taken into
account that CML is a relatively rare disease with an
even lower prevalence of those eligible to discontinue
4. A possible reconsideration of the sample size is expected
as the first 10 patients will have been recruited and pre-
liminary results will be available.
Stascal data
The study objecve is addressed in an exploratory man-
ner to idenfy the risk prole of CML paents at dierent
disease stages. Descripve stascs will be used to summa-
rize sociodemographic, clinical and psychological/cognive
data (paent preferences, cognive measures of risk a-
tude, risk preferences and need for cognive closure, and
measures of personality traits related to risk) by means of
frequency, median, mean, SD, range, and condence inter-
vals. Descripve stascs will give an overview of the study
populaon. This will be synthesized with a graph for distri-
buon of the study populaon, esmates of means, medi-
ans and standard errors. In addion, a scaerplot will be
generated to idenfy and examine possible outliers in the
sample. The data will be analyzed using the SPSS soware,
version 22 or higher.
A documentaon form will be completed for each pa-
ent. The forms will be reviewed for accuracy and com-
pleteness by the principal invesgator. Data will be entered
directly into SPSS. Computer-aided data validaons will be
performed on an ongoing basis. Coding of medical terms
and medicaon will be done using the current versions
of coding diconaries (Medical Diconary for Regulatory
Acvies [MedDRA] and World Health Organizaon Drug
Diconary Enhanced [WHO-DDE]) as specied in the data
management plan. Quesonnaire data transformed into
SPSS will undergo further detailed analysis by the principal
invesgator, who is an expert in psychological analysis.
Stopping treatment with TKIs appears interesng and at
the same me challenging to many paents. This choice has
the potenal to drascally modify clinical pracce in the man-
agement of CML in the near future. Analyzing how and when
paents would consider this opon is an important aspect in
the care of this condion. Understandably, as the few avail-
able studies and reports have discussed, many paents re-
port fear about the choice because it makes them feel they
lose control over the disease. Moreover, they may be fright-
ened by the possibility of disease resistance upon restarng
TKI therapy aer treatment interrupon.
TAbLE II - Clinical and sociodemographic data
Clinical data Demographic data
Treatment history Marital status (past, current)
Disease history Partnership
Concomitant diseases Living situaon (e.g., household
size, geographical locaon)
Treatment modality Professional situaon (e.g.,
employment status)
Concomitant treatment Educaon
Medical visits
Riva et al 221
© 2015 INTM, Italy. Published by Wichg Publishing
This study is unique in that it will analyze in depth all pos-
sible psychological, cognive and emoonal variables that can
inuence the medical decision of treatment disconnuaon
in CML, giving insights that can be used in clinical pracce for
informing future discussions with paents who consider stop-
ping treatment with TKIs. Moreover, the study will provide new
informaon to plan future clinical trials on CML treatment dis-
The study group want to thank Prof. Paolo Corradini (Univer-
sity of Milan) and all the other REL (Rete Ematologica Lombarda-
Hematological Network of Lombardy) members who have expressed
interest for this study.
Financial support: The study is supported by the University of
Milan, which has received a limited grant from Novars for supporng
regulatory procedures.
Conict of interest: None of the authors has any nancial interest
related to this study to disclose.
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... Thus, these factors should be considered when discussing TFR with patients. 18 The main reasons for patients wanting to discontinue TKIs are to reduce the potential side effects of long-term TKI therapy, decrease medication costs, and ease the inconvenience of taking daily medication. 19,20 The main anxiety that patients have experienced regarding stopping TKI therapy is a fear of disease recurrence or progression 18,19 ; however, to date, this has not been documented. ...
... 18 The main reasons for patients wanting to discontinue TKIs are to reduce the potential side effects of long-term TKI therapy, decrease medication costs, and ease the inconvenience of taking daily medication. 19,20 The main anxiety that patients have experienced regarding stopping TKI therapy is a fear of disease recurrence or progression 18,19 ; however, to date, this has not been documented. 2,7 A recent Italian observational study found that about 82% of patients would be willing to stop TKI therapy if their disease were likely to remain stable and the probability of a response to TKI therapy if treatment needed to be restarted were high. ...
... Patients were also more likely to attempt TFR if their risk of recurrence was < 30%. 18 In addition, not all patients who are eligible for TFR will be willing to discontinue treatment. In a recent survey, 49% of Italian patients with CML (total, n ¼ 1133) and 34% of US patients with CML (total, n ¼ 84) would not choose to discontinue treatment owing to concerns of disease recurrence. ...
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Treatment-free remission after discontinuation of tyrosine kinase inhibitor therapy is now an emerging treatment goal in patients with chronic myeloid leukemia, who have achieved a deep and stable response to treatment. While guidance are now available, considering patients’ questions on this progressive concept have yet to be addressed. The overall aim of this European Steering Group is a patient-centered approach that educates patients on their treatment options, including treatment-free remission, facilitates better patient-physician relationships, and meets patients’ emotional and psychological needs. This article outlines five key topic areas on discontinuing tyrosine kinase therapy and the implications of treatment-free remission for patient-physician consideration: what treatment-free remission is and when it is appropriate; which patients may and may not be eligible for treatment-free remission; what patient considerations for discontinuing therapy are, such as tyrosine kinase withdrawal syndrome, potential psychological implications, molecular recurrence and re-treatment. This Steering Group advocates that patients with chronic myeloid leukemia should have access to high quality, frequent molecular monitoring and be managed in a specialist centre with appropriate medical and psychological support. As patient concerns on attempting treatment-free remission become forefront in patient-physician discussions, a greater number of eligible patients may be willing to discontinue therapy.
... Moreover, the decision to cease therapy may not always be a rational one: Riva et al found that both emotional and cognitive components influenced the decision to attempt TFR. 47 They concluded that psychological reasons underlying the decision to halt treatment should be taken into consideration. Undoubtedly, this is a decision that is modulated by many factors, and one where patients' wishes and fears must be considered and respected. ...
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Chronic myeloid leukemia (CML) has become a chronic disease, for which the chronic phase is manageable with tyrosine kinase inhibitor (TKI) therapy. Patients with optimal responses to TKIs have achieved long‐term survival, and treatment‐free remission (TFR) has since become an additional treatment goal in CML. In this review, we discuss important factors to consider prior to stopping treatment. In addition, published and presented data with the first‐generation TKI imatinib, as well as current clinical trials evaluating TFR with the second‐generation TKIs dasatinib and nilotinib, are examined. Results obtained outside of clinical trials have been included as well. Because successful TKI discontinuation depends upon accurate BCR‐ABL1 monitoring, emerging technologies are also discussed. Clinical data obtained to date indicate that for many patients who achieve deep molecular response (DMR) on TKI therapy, TFR is a safe treatment goal, and, if the response is lost, patients can expect to regain their responses immediately upon reinitiation of TKI. It is also clear that there remains much room for improvement to make TFR a successful reality for most patients. Data from ongoing trials should help refine decisions as to which patients are the best candidates to attempt TKI discontinuation with safe monitoring in place. This article is protected by copyright. All rights reserved.
... One characteristic of blood tumors is that it is not possible to " limit the disease " to a particular region of the body as the entire organism is affected by the disease. Some authors reported that differently from patients with a solid tumor (e.g., breast and prostate tumor), blood tumors patients, have more troubles understanding, and managing health information and health behavior (Riva et al., 2015; Riva and Pravettoni, 2016). This difficulty is strictly related to the unfeasibility to detect a definite disease's site (Baccarani et al., 2014). ...
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Scholars underline the pivotal role of tobacco cigarette smoking in carcinogenesis process for blood tumors. A controversial debate is represented by the diffusion of tobacco use in young cancer survivors that had a previous diagnosis of blood tumor during the childhood. Compared with their peers, scientific evidence highlights that pediatric survivors have more difficult to give-up cigarette smoking. Furthermore, tobacco-smoking is frequently linked with others risk behaviors as drinking or substance abuse. In reviewing the main knowledge on this topic, authors affirm the need for increasing research on blood cancer survivors in order to depict psychological characteristics of pediatric blood cancer survivors. Improving health decision-making skills in young survivors could reduce the risk to adopt un-healthy behaviors and increase psychological wellbeing. Furthermore, authors propose tailored antismoking interventions based on the knowledge of the psychological and cognitive factors that support smoking during the transition toward emerging-adulthood.
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The advent of "personalized medicine" has been driven by technological advances in genomics. Concentration at the subcellular level of a patient's cancer cells has meant inevitably that the "person" has been overlooked. For this reason, we think there is an urgent need to develop a truly personalized approach focusing on each patient as an individual, assessing his/her unique mental dimensions and tailoring interventions to his/her individual needs and preferences. The aim of this study was to develop and test the psychometric properties of the ALGA-Breast Cancer (ALGA-BC), a new multidimensional questionnaire that assesses the breast cancer patient's physical and mental characteristics in order to provide physicians, prior to the consultation, with a patient's profile that is supposed to facilitate subsequent communication, interaction, and information delivery between the doctor and the patient. The specific validation processes used were: content and face validity, construct validity using factor analysis, reliability and internal consistency using test-retest reliability, and Cronbach's alpha correlation coefficient. The exploratory analysis included 100 primary breast cancer patients and 730 healthy subjects. The exploratory factor analysis revealed eight key factors: global self-rated health, perceived physical health, anxiety, self-efficacy, cognitive closure, memory, body image, and sexual life. Test-retest reliability and internal consistency were good. Comparing patients with a sample of healthy subjects, we also observed a general ability of the ALGA-BC questionnaire to discriminate between the two. The ALGA-BC questionnaire with 29 items is a valid instrument with which to obtain a patient's profile that is supposed to help physicians achieve meaningful personalized care which supplements biological and genetic analyses.
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Background: Chronic back pain (CBP) represents a significant public health problem. As one of the most common causes of disability and sick leave, there is a need to develop cost-effective ways, such as Internet-based interventions, to help empower patients to manage their disease. Research has provided evidence for the effectiveness of Internet-based interventions in many fields, but it has paid little attention to the reasons why they are effective. Objective: This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment, their management of the disease, and, ultimately, health outcomes. Methods: A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof. The intervention took 8 weeks. A baseline, a mid-term after 4 weeks, and a final assessment after 8 weeks measured patient empowerment, physical exercise, medication misuse, and pain burden. Results: All patients completed the study. Overall, the intervention had a moderate effect (F1.52=2.83, P=.03, η(2)=0.30, d=0.55). Compared to the control group, the availability of interactive sections significantly increased patient empowerment (midterm assessment: mean difference=+1.2, P=.03, d=0.63; final assessment: mean difference=+0.8, P=.09, d=0.44) and reduced medication misuse (midterm assessment: mean difference=-1.5, P=.04, d=0.28; final assessment: mean difference=-1.6, P=.03, d=-0.55) in the intervention group. Both the frequency of physical exercise and pain burden decreased, but to equal measures in both groups. Conclusions: Results suggest that interactive sections as part of Internet-based interventions can positively alter patients' feelings of empowerment and help prevent medication misuse. Detrimental effects were not observed. Trial registration: NCT02114788; (Archived by WebCite at
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Several factors influence patients' trust, and trust influences the doctor-patient relationship. Recent literature has investigated the quality of the personal relationship and its dynamics by considering the role of communication and the elements that influence trust giving in the frame of general practitioner (GP) consultations. We analysed certain aspects of the interaction between patients and GPs to understand trust formation and maintenance by focusing on communication channels. The impact of socio-demographic variables in trust relationships was also evaluated. A cross-sectional design using concurrent mixed qualitative and quantitative research methods was employed. One hundred adults were involved in a semi-structured interview composed of both qualitative and quantitative items for descriptive and exploratory purposes. The study was conducted in six community-based departments adjacent to primary care clinics in Trento, Italy. The findings revealed that patients trusted their GP to a high extent by relying on simple signals that were based on the quality of the one-to-one communication and on behavioural and relational patterns. Patients inferred the ability of their GP by adopting simple heuristics based mainly on the so-called social "honest signals" rather than on content-dependent features. Furthermore, socio-demographic variables affected trust: less literate and elderly people tended to trust more. This study is unique in attempting to explore the role of simple signals in trust relationships within medical consultation: people shape trust and give meaning to their relationships through a powerful channel of communication that orbits not around words but around social relations. The findings have implications for both clinicians and researchers. For doctors, these results suggest a way of thinking about encounters with patients. For researchers, the findings underline the importance of analysing some new key factors around trust for future investigations in medical practice and education.
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This study intends to contribute to a research tradition that asks how causal attributions of illnesses affect coping behavior. Causal attributions are understood as the most important element of illness representations and coping as a means to preserve quality of life. The issue is applied to a condition so far often neglected in research on illness representations-back pain-and a third concept is added to the picture: culture. The aim of this study is (a) to explore the causal factors to which persons with back pain attribute the further course of their illness, (b) to find out whether the attributed causes are predictors of coping maxims, and (c) to find out whether cultural factors affect attributions and coping and moderate the relationship between the two. A total of 1259 gainfully employed or self-employed persons with recent episodes of back pain were recruited in the three language regions of Switzerland. They were asked to complete a structured online interview, measuring among many other variables attributed causes, coping maxims, and affiliation to one of the Swiss micro-cultures (German-, French- or Italian-speaking). Attributed causes of the illness that can be influenced by a patient go along with more active coping styles. Cultural affiliation impacts on coping maxims independently, but culture moderates the relationship of attributed causes and coping maxims only in two of twenty possible cases. The results show that cultural differences can be analytically incorporated in the models of illness representations. Results may help to improve healthcare providers' communication with patients and plan public health campaigns. The approach to micro-cultural differences and the substantive relationships between alterability of causes and activity in coping may help the further development of models of illness representations.
2299 Before the imatinib era and besides allogeneic hematopoietic stem cell transplantation (HSCT), interferon alpha (IFN) was an alternative therapeutic option to treat chronic myeloid leukemia (CML). In very rare situations, some patients achieved a complete molecular remission (CMR) defined as the absence of detectable BCR-ABL transcript using qualitative PCR available at that time.We previously reported the outcome of patients with CML in complete cytogenetic remission after cessation of IFN (J Clin Oncol., 2002, 20:214-220.). Here, we update this experience with a long outcome after discontinuation of IFN. The main criteria for IFN discontinuation was the achievement of a sustained CMR lasting for at least two years. Twenty-one patients (9 males, 12 females; median age 39 years) were eligible for this study. One, 2 and 18 pts belonged to respectively high, intermediate and low risk group according to the Sokal score.All patients were treated with IFN (median dose 56ui/week) during a median time of 7.5 years (2.4-14) and 4 of them received an autologous HSCT. The median time to achieve CMR was 54 month (5-140). The median follow up after discontinuation of IFN treatment was 8 years (mean 9, range 5–18). Quantitative PCR was used to quantify BCR-ABL and evaluate residual disease. We distinguished two groups of patient according to the molecular pattern: group 1 (n=12) regards patients with sustained CMR confirmed by quantitative PCR. One patient belonging to this group relapsed and progressed suddenly after 5 years of IFN discontinuation and was treated with allogeneic HSCT. Group 2 (n=9) regards patients who are not in CMR with leukemic cells detectable by RQ-PCR. Six of them exhibit a fluctuation of BCR-ABL detection assessed by RQ-PCR. For the 3 other patients with a median follow up of 6 years after discontinuation, RQ-PCR became clearly positive after a median time of 2 years with a level of residual disease that corresponds to the definition of major molecular response (3 log reduction of BCR-ABL). No progression was observed in this group. So we conclude that the persistence of leukemic cells at low level after discontinuation of IFN treatment does not automatically lead to CML relapse. This long term follow up after IFN discontinuation raises the question of the need of a complete eradication of residual leukemic cells to cure the disease Disclosures No relevant conflicts of interest to declare.
Over the past decade, a broad array of drugs designed to selectively inhibit protein tyrosine kinases (tyrosine kinase inhibitors or TKIs) have emerged as novel therapies for cancer patients. Chronic myeloid leukemia (CML) is one of the best examples of successful targeted therapy with a TKI. The overall survival of CML patients who respond to treatment is close to that of the healthy population. The response in many patients is so profound that it is possible to consider stopping their treatment and with time, the number of patients in this group has increased to the point where the issue of treatment cessation has become of utmost importance. This has led to the development of a new concept in the evaluation of CML entitled treatment-free remission. It will be the criterion to evaluate the success of future clinical trials, especially if we want to improve the management of the disease to the point where we can claim to have cured CML.
Primary Nursing (PN) is a model of care delivery which is described to favor patient participation, as a Primary Nurse is responsible for coordinating all aspects of care including discharge planning. The purpose of this paper is to explore patient-nurse interactions in a rehabilitation clinic in which PN is used. Twenty-five interactions of video-recorded data involving 12 patients with their primary nurse were included in this paper and analyzed using conversation analysis, an inductive data-driven approach. Our findings suggest that nurses use two different communicative styles – a “reciprocal” or a “individual” perspective – when discussing discharge decisions with patients. While the “reciprocal” style is a more collaborative approach, the “individual” communicative practice is more unilateral. Making those different approaches explicit might lead to refinement of Primary Nursing theories.
Chronic myeloid leukemia (CML) was a fatal disease for almost all patients until the introduction of allogeneic stem cell transplantation (SCT) and of interferon-alfa (IFNα). However, these were of benefit only for a minority of patients.[1][1] The targeted therapies, first imatinib, then the other
Mrs G is a 54-year-old woman with a diagnosis of chronic-phase chronic myeloid leukemia dating back 8 years. She had a low-risk Sokal score at diagnosis and was started on imatinib mesylate at 400 mg orally daily within one month of her diagnosis. Her 3-month evaluation revealed a molecular response measured by quantitative RT-PCR of 1.2% by the International Scale. Within 6 months of therapy, she achieved a complete cytogenetic response, and by 18 months, her BCR-ABL1 transcript levels were undetectable using a quantitative RT-PCR assay with a sensitivity of ≥ 4.5 logs. She has maintained this deep level of response for the past 6.5 years. Despite her excellent response to therapy, she continues to complain of fatigue, intermittent nausea, and weight gain. She is asking to discontinue imatinib mesylate and is not interested in second-line therapy. Is this a safe and reasonable option for this patient?