CARE-Melanoma Trial

NCT ID: NCT07320222

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2026-11-30

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.

Conditions

Melanoma (Skin Cancer)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

CARE Intervention Group

This intervention group will include four peri-operative intervention sessions, the total intervention time will be approximately 4 months, with two of the intervention sessions will occur prior to surgery, and two occurring post-surgery. At the pre-surgery sessions individuals 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. They 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.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

Includes education on the benefit of exercise and how to exercise safely, rehabilitation to maximize strength, range of motion, and function, set up with a tailored exercise program by a trained physiotherapist or kinesiologist, goal setting and action planning.

Usual Care

This group will receive usual care (no rehabilitation intervention).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rehabilitation

Includes education on the benefit of exercise and how to exercise safely, rehabilitation to maximize strength, range of motion, and function, set up with a tailored exercise program by a trained physiotherapist or kinesiologist, goal setting and action planning.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jenna Smith-Turchyn, PT, PhD

Role: CONTACT

smithjf@mcmaster.ca

19058690599

Other Identifiers

CARE-Melanoma

Identifier Type: -

Identifier Source: org_study_id