Feasibility and Relevance of an Intervention with Systematic Screening as a Base for Individualized Rehabilitation in Breast Cancer Patients: A Pilot Trial of the ReScreen Randomized Controlled Trial.

Background: A substantial proportion of women with breast cancer (BC) experience a wide range of long-term persistent and troublesome side effects related to the disease and its treatment. The ReScreen randomized controlled trial is conducted aiming to evaluate the effect of early screening of distress followed by individualized rehabilitation after primary BC treatment. Purpose: To examine recruitment, retention, distribution of distress, relevance of intervention and reported problems in a pilot trial of the ReScreen RCT. Patients and methods: Based on international research, a cutoff of ≥7 on the Distress Thermometer was used to identify women in need of extended support. Those who reported high distress were randomized to intervention group (IG, n = 9) or control group (CG, n = 9), while women with low distress formed an observational group (OG, n = 67). Self-reported data was collected at baseline, 2 weeks and 3, 6, 9, and 12 months after start of treatment. The participants were recruited from a BC unit in Sweden. Descriptive statistics were used for analyses. Results: Eighty-five patients consented to participate. The recruitment rate was 73%, answer frequency was 98%, 64%, 95%, and retention rate was 100%, 56%, 91% in the IG, CG and OG, respectively. Few systematic errors were identified. When exploring the distribution of distress, it was evident that the participants scoring ≥7 were fewer (21.2%) than reported in previous studies (34-43%). The most commonly problems reported were in line with previous reports of symptoms, including fatigue and worry. Conclusion: The satisfactory rates of inclusion and data collection and the few systematic errors indicate that the ReScreen study is feasible if well planned and executed. To identify patients in need of extended support, an adjustment of the cutoff in the main study is indicated. Based on self-reported problems, the intervention was found relevant in this context.