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)

Susan J. Harnas; Hans Knoop; Floor Bennebroek Evertsz; Sanne H. Booij; Joost Dekker; Hanneke W. M. van Laarhoven; Marije van der Lee; Ellen Meijer; Louise Sharpe; Mirjam A. G. Sprangers; Annemieke van Straten; Sonja Zweegman; Annemarie M. J. Braamse

doi:10.1186/s13063-021-05657-z

Trials (Oct 2021)

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)

Susan J. Harnas,
Hans Knoop,
Floor Bennebroek Evertsz,
Sanne H. Booij,
Joost Dekker,
Hanneke W. M. van Laarhoven,
Marije van der Lee,
Ellen Meijer,
Louise Sharpe,
Mirjam A. G. Sprangers,
Annemieke van Straten,
Sonja Zweegman,
Annemarie M. J. Braamse

Affiliations

Susan J. Harnas: Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam
Hans Knoop: Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam
Floor Bennebroek Evertsz: Department of Medical Psychology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam
Sanne H. Booij: Department of Developmental Psychology, Faculty of Behavioural and Social Sciences, University of Groningen
Joost Dekker: Department of Psychiatry, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, VU University
Hanneke W. M. van Laarhoven: Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam
Marije van der Lee: Research Department, Center for Psycho-Oncology, Helen Dowling Institute
Ellen Meijer: Department of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam
Louise Sharpe: School of Psychology, Faculty of Science, University of Sydney
Mirjam A. G. Sprangers: Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam
Annemieke van Straten: Department of Clinical, Neuro and Developmental Psychology & Amsterdam Public Health Research Institute, VU University
Sonja Zweegman: Department of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam
Annemarie M. J. Braamse: Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam

DOI: https://doi.org/10.1186/s13063-021-05657-z
Journal volume & issue: Vol. 22, no. 1
pp. 1 – 16

Abstract

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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.

Published in Trials

ISSN: 1745-6215 (Online)
Publisher: BMC
Country of publisher: United Kingdom
LCC subjects: Medicine: Medicine (General)
Website: https://trialsjournal.biomedcentral.com

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