TY - JOUR
T1 - Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors
T2 - study protocol of a randomized controlled trial (MATCH-study)
AU - Harnas, Susan J.
AU - Knoop, Hans
AU - Bennebroek Evertsz, Floor
AU - Booij, Sanne H.
AU - Dekker, Joost
AU - van Laarhoven, Hanneke W. M.
AU - van der Lee, Marije
AU - Meijer, Ellen
AU - Sharpe, Louise
AU - Sprangers, Mirjam A. G.
AU - van Straten, Annemieke
AU - Zweegman, Sonja
AU - Braamse, Annemarie M. J.
N1 - Funding Information: This study is funded by the Dutch Cancer Society (Project number: 11351), the Netherlands. The Dutch Cancer Society will not be involved in the analysis and interpretation of data, in writing manuscripts, or in deciding to submit manuscripts for publication. Results of this study will be disseminated regardless of the magnitude or direction of the effect. Funding Information: The sponsor of this study is Amsterdam University Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam. Other participating hospitals and centers are as follows: Amsterdam University Medical Center, VU University; Leiden University Medical Center; Utrecht University Medical Center; Flevoziekenhuis; Hospital Amstelland; Helen Dowling Institute; Expert Center for Chronic Fatigue; VieCuri Medical Center; and Rijnstate Hospital, The Netherlands. We would like to thank the Conquer Fear Authorship group for making available the content for the FCR treatment. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Cancer survivors
KW - Cancer-related fatigue
KW - Cognitive behavioral therapy
KW - Depression
KW - Ecological momentary assessment (EMA)
KW - Fear of cancer recurrence
KW - Personalized treatment
KW - Psychological symptoms
UR - http://www.scopus.com/inward/record.url?scp=85117346325&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-021-05657-z
DO - https://doi.org/10.1186/s13063-021-05657-z
M3 - Article
C2 - 34641961
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 696
ER -
