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NCT Number: NCT07320222

CARE-Melanoma Trial

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retention rate

    Time frame: 4 months

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

Secondary outcomes

  1. Adherence rate

    Time frame: 4 months

    Adherence in this project will be assessed by adherence to the rehabilitation session (measured as %).

  2. Recruitment rate

    Time frame: 4 months

    Recruitment rate is the percentage of eligible individuals approached for the study who enrol in the study.

  3. Change in overall impairment score

    Time frame: 4 months

    Measured via the Edmonton Symptom Assessment Scale at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 100 - higher scores represent higher levels of overall impairment.

  4. Change in Physical Activity Level

    Time frame: 4 months

    Measured via the Godin Leisure Time Exercise Questionnaire at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of physical activity.

  5. Change in functional mobility

    Time frame: 4 months

    Measured via the 30 second sit to stand at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of functional mobility.

  6. Change in functional mobility

    Time frame: 4 months

    Measured via the six minute walk test at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of functional mobility.

  7. Change in Grip Strength

    Time frame: 4 months

    Measured via the handheld dynamometer at baseline and 4 month follow-up

  8. Change in quality of life

    Time frame: 4 months

    Measured via the Functional Assessment of Cancer Therapy (FACT)-Melanoma at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 204 - higher scores represent higher levels of quality of life.

  9. Change in perception of health status

    Time frame: 4 months

    Measured via the EQ-5D-3L VAS (no extended title) at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 100 - higher scores represent higher perceptions of health status.

  10. Medication use

    Time frame: 4 months

    Measured via a self-report scale at 4 month follow-up. Minimum score: 0 (no medication used), Maximum score: no maximum - higher scores represent higher use of medications.

  11. Change in range of motion

    Time frame: 4 months

    Measured via the goniometer at baseline and 4 month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Smith-Turchyn, PT, PhD

CONTACT

[email protected]

19058690599

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

A Coordinated Approach to Peri-operative Rehabilitation to Enhance Outcomes in Melanoma: the CARE-Melanoma Pilot Randomized Controlled Trial

Acronym: CARE-Melanoma

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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