A Coordinated Approach to Perioperative Rehabilitation to Enhance Outcomes in Melanoma: Protocol for the CARE-Melanoma Pilot Randomized Controlled Trial

BACKGROUND: Rehabilitation is beneficial for individuals with cancer across all phases of care, but access remains limited for many survivors, including individuals with melanoma. As new treatment strategies for melanoma are introduced, there is an opportunity to assess perioperative rehabilitation strategies for patients undergoing surgery during and after neoadjuvant treatment. OBJECTIVE: This paper describes the protocol for a 2-armed pilot randomized controlled trial with the overall objective of determining the feasibility and preliminary effects of a perioperative rehabilitation strategy for individuals with melanoma at a single cancer institution in Ontario, Canada. METHODS: In total, 30 participants, including English-speaking adults with a current melanoma diagnosis scheduled to undergo surgery after neoadjuvant immunotherapy, will be randomized 1:1 to either the intervention or control group. The intervention will include 4 perioperative intervention sessions (2 sessions before surgery and 2 sessions after surgery) led by a trained physiotherapist or kinesiologist. Participants in the intervention group will receive education on the benefits of exercise; how to exercise safely; and rehabilitation techniques to maximize range of motion, strength, and function. Participants will also receive a tailored exercise program and will establish goals and action plans at each session. The control group will receive usual care (no rehabilitation). The primary outcome is feasibility (measured via recruitment, retention, and adherence rates). Secondary outcomes will be collected before and after the intervention and include overall impairment score (measured via the Edmonton Symptom Assessment Scale), physical activity level (Godin Leisure Time Exercise Questionnaire), functional mobility (6-minute walk test and 30-second sit-to-stand test), range of motion (goniometry), grip strength (handheld dynamometry), quality of life (Functional Assessment of Cancer Therapy-Melanoma), perception of health status (EQ-5D-3L), and medication use. Feasibility will be analyzed using descriptive statistics (mean [SDs] or frequency [%]), as appropriate. Secondary outcomes will be reported using means, SD, and CIs of outcomes. Cohen d effect sizes will be calculated and reported for each secondary outcome to inform a future full-scale trial. STATA/MP (version 14) will be used for all statistical analysis, with significance set at P<.05. RESULTS: Trial enrollment began in June 2026, and 3 participants have been recruited to date. Recruitment is expected to be completed by December 2026. Results will be submitted for publication by mid or late 2027. CONCLUSIONS: This pilot trial aims to address the evidence gap on the feasibility and preliminary effects of rehabilitation for individuals with melanoma, laying the groundwork for a larger randomized controlled trial and future implementation of rehabilitation for this population. By implementing rehabilitation around the surgical phase, we aspire to enhance patient outcomes by maximizing function and reducing side effects, facilitating a faster return to meaningful daily activities. TRIAL REGISTRATION: ClinicalTrials.gov NCT07320222; https://clinicaltrials.gov/study/NCT07320222. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/90946.