Actively Recruiting
Pragmatic Hybrid Type 1 Effectiveness-implementation Trial of a Virtual Cancer Rehabilitation Program
Led by University Health Network, Toronto · Updated on 2026-02-25
388
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a virtual cancer rehabilitation program called CaRE@Home for cancer survivors who have ongoing impairments related to their cancer treatment. This study is a multi-center pragmatic randomized controlled trial aiming to assess the effectiveness of an 8-week online rehabilitation intervention compared to usual care. The trial also explores how well the program can be implemented and integrated into different cancer care settings across multiple sites in Canada. Participants randomized to the CaRE@Home group will take part in an 8-week virtual program that includes weekly interactive education modules to support self-management, individualized exercise plans delivered via a mobile app, wearable Fitbit devices to monitor activity and sleep, and weekly coaching calls with rehabilitation professionals. The usual care group will receive general exercise recommendations and supportive care as usual, with an option to join the CaRE@Home program after completing the 3-month post-intervention assessment. Both groups will be assessed at baseline, immediately post-intervention (8 weeks), and at 3 months post-intervention, with the CaRE@Home group followed additionally at 6 months to assess maintenance. Throughout the study, participants will complete patient-reported outcome questionnaires and physiological assessments including physical functioning, social functioning, anxiety, work status, and fitness measures. Data will be collected at multiple time points to evaluate disability as the primary outcome and other health and quality of life measures as secondary outcomes. Safety and adherence will be monitored, and the study includes a process evaluation to understand factors affecting implementation. The total study duration per participant includes the initial 8-week program and follow-ups up to 6 months after completion.
CONDITIONS
Brief Title
Virtual Rehabilitation for Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck (stage I-III), or lymphoma/lymphoproliferative disorder (excluding recurrent, refractory, progressive, or transplant cases)
- Completed primary cancer treatment (surgery, radiation, or systemic therapy) within the last 24 months
- If on systemic therapy with adjuvant or maintenance intent, eligible if main treatment phase is completed or currently receiving certain therapies (e.g., trastuzumab, immunotherapy, rituximab, oral endocrine or targeted therapy)
- Able to communicate sufficiently in English to participate
- Willing to be randomized, participate in the intervention, and attend assessments (virtual or in-person)
- Have internet access
- Indication for cancer rehabilitation with WHO-DAS score greater than 5
You will not qualify if you...
- Impaired functional status that prevents rehabilitation (PRFS score greater than 3)
- Indication of major depressive disorder (PHQ-9 score 20 or higher)
- Diagnosis of neurological disease or condition significantly limiting cognitive function (e.g., Alzheimer's, dementia, severe brain injury)
- Currently enrolled in another personalized and supervised exercise or rehabilitation program
- Conditions or injuries unsuitable for distance exercise without medical approval (e.g., high blood pressure, recent heart attack, unstable angina, spinal cord compression, recent deep vein thrombosis)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person or virtual)
Duration - 1 day
Participants provide consent and complete baseline patient-reported and physiological assessments with a trained assessor before randomization.
1 baseline assessment visit (in-person or virtual)
Duration - 8 weeks
Participants randomized to the CaRE@Home intervention complete an 8-week virtual program including weekly 1-hour group exercise sessions, self-management education modules, and weekly telephone coaching to support exercise adherence and behavioral change.
Weekly virtual sessions and weekly telephone coaching calls during weeks 2 to 7
Duration - Up to 6 months post-intervention
Participants complete follow-up assessments to monitor progress and adapt exercise plans as needed. The CaRE@Home group has additional follow-up to assess maintenance of treatment gains.
Follow-up assessments at 8 weeks (immediate post-intervention), 3 months post-intervention for all participants, plus an additional 6-month post-intervention assessment for the CaRE@Home group
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
C
charmaine silva, MSc
J
Jennifer Jones, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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