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The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is:
• Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN?
Participants in both study groups will be asked to:
• Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
Participants in the EX-CIPN group will be asked to:
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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. |
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| Usual Care Control | No Intervention | This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months) |
| 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 specific to CIPN symptoms. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will progress the exercise program as needed, discuss and develop goals, and identify potential barriers and solutions in achieving their goals. After the 10-week intervention participants will receive a 3-month maintenance phase with 2 monthly remote check-ins. |
| Measure | Description | Time Frame |
|---|---|---|
| CIPN Symptoms | 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 (22 weeks), 6-months post-intervention (34 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| CIPN-related disability | Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-R-ODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes. | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Antonen, MSc | Contact | 416-634-7784 | eric.antonen2@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ELLICSR: Health Wellness and Cancer Survivorship Centre | Recruiting | 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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A pragmatic, parallel group, two-arm, single-blind, randomized controlled trial (pRCT)
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| Strength (Upper Body) | Measured via handgrip dynamometry or grip strength test (GST). | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 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 (22 weeks), 6-months post-intervention (34 weeks) |
| Balance | Measured using the 7-Item Berg Balance Test. The test provides a score from 0 to 28 with lower scores meaning worse outcomes. | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) |
| Gait Speed | Measured using the Four-Metre Gait Speed Test. | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) |
| Aerobic Functional Capacity | Measured using a 6-minute walk test (6MWT). | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) |