CARE-Melanoma Trial

NCT07320222 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CARE-Melanoma
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma (Skin Cancer)

Keywords

rehabilitation; melanoma; peri-operative; pilot trial

Outcome Measures

Primary Outcomes (1)

• Retention rate

  Retention rate is the number of individuals enrolled in the study who complete the intervention.

  4 months

Secondary Outcomes (11)

• Adherence rate

  4 months

• Recruitment rate

  4 months

• Change in overall impairment score

  4 months

• Change in Physical Activity Level

  4 months

• Change in functional mobility

  4 months

Study Arms (2)

CARE Intervention Group

EXPERIMENTAL

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.

Other: Rehabilitation

Usual Care

NO INTERVENTION

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

Interventions

Rehabilitation 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.

CARE Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• melanoma diagnosis
• English speaking,
• adults (\>18 years of age)
• scheduled to receive surgery after a neoadjuvant chemotherapy regime

You may not qualify if:

• \<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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Melanoma

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jenna Smith-Turchyn, PT, PhD

CONTACT

19058690599; smithjf@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two group pilot randomized controlled trial.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 6, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share