A return-to-work intervention protocol directed at cancer patients (self-assessment, tailored information & lifestyle management for returning to work among cancer patients, START): A multi-center, randomized controlled trial

Purpose This study describes the protocol for the design and evaluation of a self-assessment based educational program supporting cancer patients’ return-to-work (RTW), prior to its complete and ongoing implementation. Methods We designed a multi-center, randomized controlled trial with three follow-up points. The study population (N = 239) includes recently diagnosed cancer patients who plan to receive active treatment at two university hospitals in Korea. A pre-test is conducted at the point of enrollment for both groups. The intervention group receives a leaflet clarifying misconceptions about RTW and is shown a video clip of patient interviews concerning RTW. The control group receives a booklet about cancer and nutrition, and is not provided with further intervention. After active treatment, the intervention group receives a one-time, face-to-face education session with an oncology nurse. Following the education session, both groups receive three follow-up phone calls. The first follow-up call occurs at the end of intervention and at the end of active treatment for intervention and control groups, respectively. The next two follow-up calls will be conducted one month and a year following the post-test. The primary outcome is whether the patient has RTW or has plans to RTW, and the secondary outcome is knowledge of RTW. Results As of April 2020, 239 patients have been enrolled in the trial. Statistical analyses will be conducted upon trial completion in December 2020. Discussion We hypothesize that the provision of RTW education near diagnosis will not only enhance patients’ intentions to RTW, but also effectively encourage them to RTW.