Journal Article

Study protocol of the CORRECT multicenter trial: the efficacy of blended cognitive behavioral therapy for reducing psychological distress in colorectal cancer survivors

Thewes, B., Leermakers, L., Collette, E. H., Prins, J. B., Braamse, A. M. J., Dekker, J., Gielissen, M. F. M., de Wilt, J. H. W., Döking, S.

2018

Overview

Background Approximately one third of the colorectal cancer survivors (CRCS) experience high levels of psychological distress. Common concerns experienced by CRCS include distress related to physical problems, anxiety, fear of cancer recurrence (FCR) and depressive symptoms. However, psychological interventions for distressed CRCS are scarce. Therefore, a blended therapy was developed, combining face-to-face cognitive behavioral therapy (CBT) with online self-management activities and telephone consultations. The aim of the study is to evaluate the efficacy and cost-effectiveness of this blended therapy in reducing psychological distress in CRCS. Methods/design The CORRECT study is a two-arm multicenter randomized controlled trial (RCT). A sample of 160 highly distressed CRCS (a score on the Distress Thermometer of 5 or higher) will be recruited from several hospitals in the Netherlands. CRCS will be randomized to either the intervention condition (blended CBT) or the control condition (care as usual). The blended therapy covers approximately 14 weeks and combines five face-to-face sessions and three telephone consultations with a psychologist, with access to an interactive self-management website. It includes three modules which are individually-tailored to patient concerns and aimed at decreasing: 1) distress caused by physical consequences of CRC, 2) anxiety and FCR, 3) depressive symptoms. Patients can choose between the optional modules. The primary outcome is general distress (Brief Symptom Inventory-18). Secondary outcomes are quality of life and general psychological wellbeing. Assessments will take place at baseline prior to randomization, after 4 and 7 months. Discussion Blended CBT is an innovative and promising approach for providing tailored supportive care to reduce high distress in CRCS. If the intervention proves to be effective, an evidence-based intervention will become available for implementation in clinical practice. Trial registration This trial is registered in the Netherlands Trial Register ( NTR6025 ) on August 3, 2016.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Anxiety / Behavior modification / Biomedical and Life Sciences / Biomedicine / Blended therapy / Breast cancer / Cancer Research / Cancer survivors / Cancer Survivors - psychology / Care and treatment / Clinical trials / Cognition & reasoning / Cognitive ability / Cognitive behavior therapy / Cognitive Behavioral Therapy / Colorectal cancer / Colorectal cancer survivors / Colorectal carcinoma / Colorectal Neoplasms - psychology / Diagnosis / Epidemiology / Fear & phobias / Health aspects / Health Promotion and Disease Prevention / Humans / Intervention / Medicine/Public Health / Mental depression / Multicenter Studies as Topic / Oncology / Ostomy / Outcome Assessment, Health Care / prevention and public health / Psychological aspects / Psychological distress / Quality of Life / Quantitative psychology / Randomized controlled trial / Randomized Controlled Trials as Topic / Self-Management / Stress (Psychology) / Stress, Psychological - therapy / Studies / Study Protocol / Surgical Oncology / Systematic review