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. 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.

Is digital intervention for fear of cancer recurrence beneficial to cancer patients?: A systematic review and meta‐analysis

“…In our research, the traditional CBT study 32 exhibited the highest effect size, incorporating the assessment of patients' needs and timely delivery of related information. Further studies are warranted in this area, and a RCT comparing the effect of standardized CBT and personalized CBT is currently in progress 55 . The other possible reason is that the digital‐based interventions included in this meta‐analysis exhibited also more effective compared to the previous tele or web‐based interventions, which may have contributed to the higher overall effect size.…”

Toward implementation of an evidence‐based intervention for fear of cancer recurrence: Feasibility in real‐world psycho‐oncology practice

“…31 Together, these studies reflect the tension between the wish to implement evidence-based interventions 10 and an increased call for personalized care. 32 From a research perspective, it is important to understand how deviations from evidence-based manuals affect the effectiveness of care. This includes studies evaluating the effectiveness of tailored care, such as by Harnas et al 32 From an implementation perspective, we recommend bringing existing evidence-based interventions into practice, maintaining fidelity with core components, while equipping psychologists to make these interventions more personal.…”

“…32 From a research perspective, it is important to understand how deviations from evidence-based manuals affect the effectiveness of care. This includes studies evaluating the effectiveness of tailored care, such as by Harnas et al 32 From an implementation perspective, we recommend bringing existing evidence-based interventions into practice, maintaining fidelity with core components, while equipping psychologists to make these interventions more personal. 14,33 The uptake of FCR interventions is highly dependent upon HCPs identification of clinical FCR and their referral to psychological services.…”

“…Another study reported that evidence‐based treatments in psychosocial oncology practice are often adapted to the patients' needs 31 . Together, these studies reflect the tension between the wish to implement evidence‐based interventions 10 and an increased call for personalized care 32 . From a research perspective, it is important to understand how deviations from evidence‐based manuals affect the effectiveness of care.…”