JMIR Publications

ABSTRACT

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 a timely opportunity to assess peri-operative rehabilitation strategies for patients undergoing surgery during and after neo-adjuvant treatment.

Objective:

This paper describes the protocol for a two-armed pilot randomized controlled trial with the overall objective to determine the feasibility and preliminary effectiveness of a peri-operative rehabilitation strategy for individuals with melanoma at a single cancer institution in Ontario, Canada.

Methods:

Thirty participants, including English-speaking adults with a current melanoma diagnosis scheduled to receive surgery after a neoadjuvant immunotherapy, will be randomized 1:1 to either the CARE intervention or control group. The CARE intervention will include four peri-operative intervention sessions (two pre-surgery and two post-surgery), led by a trained physiotherapist or kinesiologist. Participants in the CARE 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. They will also be set up with a tailored exercise routine and will set goals and action plans at each session. The control group will receive usual care. The primary outcome is feasibility (measured via recruitment, retention, and adherence rates). Secondary outcomes will be collected pre- and post-intervention and include overall impairment score, physical activity level, functional mobility, range of motion, grip strength, quality of life, perception of health status, and medication use. Feasibility outcomes will be analyzed using descriptive statistics (mean (standard deviations (SD)), frequency (%)) as appropriate. Secondary outcomes will be reported using means and SD of outcomes. We will conduct exploratory t-tests between groups for each effectiveness outcome to inform a future full-scale trial. STATA/MP14 will be used for all statistical analysis with significance set at p<0.05.

Results:

Trial enrollment will begin in January 2026 and is expected to be completed by September 2026. Results will aim to be submitted for publication by early 2027.

Conclusions:

This pilot trial aims to address the gap in evidence on the feasibility and preliminary effectiveness 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 quicker return to meaningful activities in daily life. Clinical Trial: This pilot trial is registered on ClinicalTrials.gov (ID: NCT07320222).