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)
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. Person...
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| Format: | Article |
| Language: | English |
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BMC
2021-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05657-z |
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| author | 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 |
| author_facet | 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 |
| author_sort | Susan J. Harnas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-22T04:13:46Z |
| format | Article |
| id | doaj.art-3928e6b4f9064934998c2f5251917a35 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T04:13:46Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3928e6b4f9064934998c2f5251917a352022-12-21T18:39:27ZengBMCTrials1745-62152021-10-0122111610.1186/s13063-021-05657-zPersonalized 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. Harnas0Hans Knoop1Floor Bennebroek Evertsz2Sanne H. Booij3Joost Dekker4Hanneke W. M. van Laarhoven5Marije van der Lee6Ellen Meijer7Louise Sharpe8Mirjam A. G. Sprangers9Annemieke van Straten10Sonja Zweegman11Annemarie M. J. Braamse12Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of AmsterdamDepartment of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of AmsterdamDepartment of Medical Psychology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of AmsterdamDepartment of Developmental Psychology, Faculty of Behavioural and Social Sciences, University of GroningenDepartment of Psychiatry, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, VU UniversityDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of AmsterdamResearch Department, Center for Psycho-Oncology, Helen Dowling InstituteDepartment of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamSchool of Psychology, Faculty of Science, University of SydneyDepartment of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of AmsterdamDepartment of Clinical, Neuro and Developmental Psychology & Amsterdam Public Health Research Institute, VU UniversityDepartment of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamDepartment of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, University of AmsterdamAbstract 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.https://doi.org/10.1186/s13063-021-05657-zPsychological symptomsFear of cancer recurrenceDepressionCancer-related fatiguePersonalized treatmentCognitive behavioral therapy |
| spellingShingle | 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 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 Psychological symptoms Fear of cancer recurrence Depression Cancer-related fatigue Personalized treatment Cognitive behavioral therapy |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Psychological symptoms Fear of cancer recurrence Depression Cancer-related fatigue Personalized treatment Cognitive behavioral therapy |
| url | https://doi.org/10.1186/s13063-021-05657-z |
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