Melanoma (Skin Cancer)
Conditions
Keywords
rehabilitation, melanoma, peri-operative, pilot trial
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.
Interventions
OTHERRehabilitation
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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a two group pilot randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | 4 months | Retention rate is the number of individuals enrolled in the study who complete the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 4 months | Recruitment rate is the percentage of eligible individuals approached for the study who enrol in the study. |
| Change in overall impairment score | 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. |
| Change in Physical Activity Level | 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. |
| Change in functional mobility | 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. |
| Adherence rate | 4 months | Adherence in this project will be assessed by adherence to the rehabilitation session (measured as %). |
| Change in quality of life | 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. |
| Change in perception of health status | 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. |
| Medication use | 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. |
| Change in range of motion | 4 months | Measured via the goniometer at baseline and 4 month follow-up |
| Change in Grip Strength | 4 months | Measured via the handheld dynamometer at baseline and 4 month follow-up |
Contacts
Primary ContactJenna Smith-Turchyn, PT, PhD
Outcome results
None listed