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.