BackgroundApproximately 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/designThe 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.DiscussionBlended 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 registrationThis trial is registered in the Netherlands Trial Register (NTR6025) on August 3, 2016.
Objective
High psychological distress is reported by one third of colorectal cancer survivors (CRCS). However, intervention studies for CRCS have reported low participation rates. In this study, reasons for non‐participation and low uptake in a psychological intervention trial were investigated.
Methods
CRCS were recruited for a randomized clinical trial on the efficacy of blended cognitive behavior therapy for psychological distress via databases, follow‐up consultations, advertisements and an ongoing population‐based study. The recruitment flow and reasons for non‐participation were analyzed for patients recruited between 2016 and 2020. Subgroups were compared based on demographic, clinical and screening data. High distress as study entry criterion was measured with the Distress Thermometer (DT ≥ 5) and the problem list (PL).
Results
From all recruitment methods together, 1326 CRCS responded to the invitation letter of whom 510 (38%) were interested in receiving a screening questionnaire. Interested CRCS were significantly younger than non‐interested CRCS (p < 0.001). Most non‐interested CRCS reported having no complaints. Of interested CRCS, 448 (88%) completed screening with the DT of which 213 (48%) CRCS scored above the DT cutoff for high distress. The majority expressed no need for help resulting in 84 (4% of eligible) CRCS included in the trial. Younger age, shorter time since diagnosis and more problems on the PL were positively related to participation.
Conclusions
In this study a low participation rate was found. However, patients with high distress and most in need for help were included in the trial. For future research it is recommended to perform pilot‐ and feasibility studies to optimize recruitment.
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