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Melanoma (Skin Cancer)Phase 1CARE-MelanomaNCT07320222

CARE-Melanoma Trial

A Phase 1 study testing Rehabilitation in people with Melanoma (Skin Cancer), run by McMaster University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin Cancer)
What is being tested?
Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
20 Jan 2026to 30 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • <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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jenna Smith-Turchyn, PT, PhD contact

19058690599

smithjf@mcmaster.ca

About this study

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

Read the 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.

Being tested
Rehabilitation
Keywords
rehabilitation, melanoma, peri-operative, pilot trial
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    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.

Study groups in NCT07320222
Study groupRoleWhat they receive
CARE Intervention GroupExperimentalThis 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.
Receives: Other: Rehabilitation
Usual CareNo interventionThis group will receive usual care (no rehabilitation intervention).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention rate

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

    Measured: 4 months

Secondary outcomes (11)

  1. Adherence rate

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

    Measured: 4 months

  2. Recruitment rate

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

    Measured: 4 months

  3. Change in overall impairment score

    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.

    Measured: 4 months

  4. Change in Physical Activity Level

    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.

    Measured: 4 months

  5. Change in functional mobility

    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.

    Measured: 4 months

  6. Change in functional mobility

    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.

    Measured: 4 months

  7. Change in Grip Strength

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

    Measured: 4 months

  8. Change in quality of life

    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.

    Measured: 4 months

  9. Change in perception of health status

    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.

    Measured: 4 months

  10. Medication use

    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.

    Measured: 4 months

  11. Change in range of motion

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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start20 Jan 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two group pilot randomized controlled trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07320222
Sponsor's protocol ID
CARE-Melanoma
Acronym
CARE-Melanoma
Status last verified
Jan 2026
First submitted
24 Nov 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith-Turchyn J, Hvizd JL, Francescutti V. A Coordinated Approach to Perioperative Rehabilitation to Enhance Outcomes in Melanoma: Protocol for the CARE-Melanoma Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 21;15:e90946. doi: 10.2196/90946.

    PubMed 42628027

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rehabilitation in people with Melanoma (Skin Cancer), run by McMaster University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jenna Smith-Turchyn, PT, PhD (19058690599, smithjf@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07320222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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