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: * Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN? * Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)? Researchers will provide all participants with the exercise-based intervention. Participants will: * Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention * Complete a 10-week remote, individualized exercise program * Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention * Wear a FitBit throughout the study to track physical activity and promote behaviour change
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
ELLICSR: Health Wellness and Cancer Survivorship Centre
Toronto, Ontario, Canada
RECRUITINGAccrual 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Through study completion, up to 24 weeks.
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.
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
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.
Time frame: 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.
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Strength (Upper Body)
Measured via handgrip dynamometry or grip strength test (GST).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Gait Speed
Measured using the Four-Metre Gait Speed Test.
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Aerobic Functional Capacity
Measured using a 6-minute walk test (6MWT).
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
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