A Coordinated Approach to Peri-operative Rehabilitation to Enhance Outcomes in Melanoma: the CARE-Melanoma Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- McMaster University
- Enrollment
- 30
- Primary Endpoint
- Retention rate
Study Overview
Brief Summary
Melanoma, a serious skin cancer, is increasingly prevalent in Canada. Surgical intervention is essential but poses significant physical and emotional challenges. Rehabilitation is crucial for recovery, helping patients regain strength and confidence while addressing psychological needs. In Ontario, new neoadjuvant chemotherapy regimens are being introduced to improve outcomes by shrinking tumors before surgery. Despite advancements, pre-habilitation and early post-operative rehabilitation services for melanoma patients are currently lacking. This pilot trial aims to evaluate the feasibility and effectiveness of pre- and post-surgery rehabilitation strategies for melanoma patients. The purpose of this pilot trial is to determine the feasibility and preliminary effectiveness of a rehabilitation strategy for individuals with melanoma pre- and post-surgery.
Detailed Description
Melanoma, a serious skin cancer, is increasingly prevalent in Canada. Surgical intervention is essential but poses significant physical and emotional challenges. Rehabilitation is crucial for recovery, helping patients regain strength and confidence while addressing psychological needs. In Ontario, new neoadjuvant chemotherapy regimens are being introduced to improve outcomes by shrinking tumors before surgery. Despite advancements, pre-habilitation and early post-operative rehabilitation services for melanoma patients are currently lacking. This pilot trial aims to evaluate the feasibility and effectiveness of pre- and post-surgery rehabilitation strategies for melanoma patients. Participants in this study include individuals with a melanoma diagnosis who are scheduled to receive surgery after a neoadjuvant chemotherapy regime. Eligible potential participants will be referred to the study by their surgical oncologist or oncology care. Participants will be screened for eligibility by a research coordinator. Based on sample size calculations for pilot data, the investigators expect to recruit 30 participants for the study (15 in each group). Participants will be divided into two groups. The first group will include four peri-operative intervention sessions, the total intervention time will be approximately 4 months, with two of the intervention sessions occurring prior to surgery, and two occurring post-surgery. At the pre-surgery sessions participants with receive education on the benefits of exercise pre-treatment, how to exercise safely, and be set up with a tailored exercise routine by a trained physiotherapist. Participants will set goals and action plans to work until their next session. At the post-surgery sessions patients will review their function with the same physiotherapist and again be provided tailored recommendations to maximize their function. The second group will receive usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •melanoma diagnosis
- •English speaking,
- •adults (>18 years of age)
- •scheduled to receive surgery after a neoadjuvant chemotherapy regime
Exclusion Criteria
- •<18 years of age
- •are not undergoing neo-adjuvant chemotherapy
- •self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise
Outcomes
Primary Outcomes
Retention rate
Time Frame: 4 months
Retention rate is the number of individuals enrolled in the study who complete the intervention.
Secondary Outcomes
- Adherence rate(4 months)
- Recruitment rate(4 months)
- Change in overall impairment score(4 months)
- Change in Physical Activity Level(4 months)
- Change in quality of life(4 months)
- Change in Grip Strength(4 months)
- Medication use(4 months)
- Change in perception of health status(4 months)
- Change in range of motion(4 months)
- Change in functional mobility(4 months)