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| Name | Class |
|---|---|
| Cancer Research Society | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:
Researchers will provide all participants with the exercise-based intervention.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EX-CIPN Exercise- Based intervention | Experimental | This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EX-CIPN | Behavioral | The 10-week intervention includes: Individualized Exercise Program: Each participant will receive an individualized progressive exercise program that includes cardiovascular and strength training as well as balance and desensitization exercises and will be adjusted to the needs of the patient. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change and allows for self-monitoring and feedback to the participant. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin over Microsoft Teams (MSTeams) on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will review, adapt, and progress the exercise program as needed, discuss and develop goals for the following week, and identify potential barriers and solutions in achieving their goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Accrual Rate | Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month. | Throughout study completion, up to 24 weeks. |
| Retention Rates | Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data. | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Adherence | Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan | Through study completion, up to 24 weeks. |
| Intervention Safety | All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced. | Through study completion, up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measured using the numeric pain rating scale (NPRS). Scored on a 1-10 scale, 1 being no pain and 10 being worst pain imaginable. | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| CIPN Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ELLICSR: Health Wellness and Cancer Survivorship Centre | Toronto | Ontario | M5G 2N2 | Canada |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.
| Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| CIPN-related Disability | Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-RODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes. | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Strength (Upper Body) | Measured via handgrip dynamometry or grip strength test (GST). | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Strength (Lower Body) | Measured by a 30-second sit to stand test (30-s STS). | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Balance | Measured using the Short Physical Performance Battery (SPPB) Balance Test. The SPPB balance test provides a score from 0 to 4 with lower scores meaning worse outcomes. | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Gait Speed | Measured using the Four-Metre Gait Speed Test. | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |
| Aerobic Functional Capacity | Measured using a 6-minute walk test (6MWT). | Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) |