scholarly journals Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors: study protocol of a randomized controlled trial (MATCH-study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Susan J. Harnas ◽  
Hans Knoop ◽  
Floor Bennebroek Evertsz ◽  
Sanne H. Booij ◽  
Joost Dekker ◽  
...  

Abstract Background Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients’ quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. Methods The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients’ needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). Discussion To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. Trial registration The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019.

2018 ◽  
Vol 25 (2) ◽  
pp. 275-285 ◽  
Author(s):  
Josée Savard ◽  
Marie-Hélène Savard ◽  
Aude Caplette-Gingras ◽  
Lucie Casault ◽  
Caroline Camateros

2015 ◽  
Vol 24 (5) ◽  
pp. 2059-2066 ◽  
Author(s):  
Charles E. Heckler ◽  
Sheila N. Garland ◽  
Anita R. Peoples ◽  
Michael L. Perlis ◽  
Michelle Shayne ◽  
...  

2017 ◽  
Vol 11 (3) ◽  
pp. 401-409 ◽  
Author(s):  
Anita R. Peoples ◽  
Sheila N. Garland ◽  
Michael L. Perlis ◽  
Josée Savard ◽  
Charles E. Heckler ◽  
...  

10.2196/15178 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e15178 ◽  
Author(s):  
Utkarsh B Subnis ◽  
Norman AS Farb ◽  
Katherine-Ann Laura Piedalue ◽  
Michael Speca ◽  
Sasha Lupichuk ◽  
...  

Background Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. Objective The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. Results The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. Conclusions Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. Trial Registration ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 International Registered Report Identifier (IRRID) DERR1-10.2196/15178


2021 ◽  
pp. 755-759
Author(s):  
Allan B. Smith ◽  
Joanna E. Fardell ◽  
Phyllis N. Butow

Fear of cancer recurrence (FCR) is broadly defined as “fear, worry or concern relating to the possibility that cancer will come back or progress.” Some degree of FCR is almost universal among cancer survivors, and management of FCR is frequently reported as an unmet need. Conceptualization and measurement of FCR remain challenging, as consensus regarding its multidimensional nature and clinical presentation is yet to be established. Accordingly, estimated prevalence rates of “clinical FCR” vary widely. Research suggests that if left untreated FCR remains stable over time, and that those who are younger, have greater symptom burden, and experience greater psychological distress are likely to experience more FCR. In contrast, medical (diagnosis staging, treatment, etc.) and other demographic variables do not appear to be strongly associated with FCR levels, making identification of FCR in clinical practice difficult. Brief FCR screening measures have been developed, but further work validating clinical cut-offs is needed. Those who experience a high level of FCR have poorer quality of life and experience difficulties moving on with their life after cancer diagnosis and treatment. A growing number of interventions have demonstrated efficacy in addressing FCR in recent years, with those using contemporary cognitive-behavioral therapy approaches focused on how patients relate to their thoughts, rather than on changing the contents of thoughts, shown to be most effective. Priorities for future research include development of treatment models, such as stepped care, that address the varying levels of FCR in cancer survivors and use interventions of varying intensity to efficiently address FCR.


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