CARE-Melanoma Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehabilitation.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Coordinated Approach to Peri-operative Rehabilitation to Enhance Outcomes in Melanoma: the CARE-Melanoma Pilot Randomized Controlled Trial
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Retention rate [Time frame: 4 months]
Secondary outcome measures (11)
- Adherence rate [Time frame: 4 months]
- Recruitment rate [Time frame: 4 months]
- Change in overall impairment score [Time frame: 4 months]
- Change in Physical Activity Level [Time frame: 4 months]
- Change in functional mobility [Time frame: 4 months]
- Change in functional mobility [Time frame: 4 months]
- Change in Grip Strength [Time frame: 4 months]
- Change in quality of life [Time frame: 4 months]
- Change in perception of health status [Time frame: 4 months]
- Medication use [Time frame: 4 months]
- Change in range of motion [Time frame: 4 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07320222 · CARE-Melanoma