Virtual rehabilitation program for cancer survivors

Pragmatic Hybrid Type 1 Effectiveness-implementation (E-I) Trial of a Virtual Cancer Rehabilitation Program

This study is testing an 8-week online rehab program for cancer survivors to see if it helps them feel better physically and socially after treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 388 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Drugs / interventions: trastuzumab, rituximab, ibrutinib, immunotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05898789 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of an 8-week virtual cancer rehabilitation program called CaRE@Home for survivors of various cancers, including breast, colorectal, head and neck cancers, and lymphoma. The program aims to improve overall disability and enhance physical and social functioning, anxiety, work status, quality of life, and physiological changes. Participants will engage in weekly online group exercise classes and self-management education, with follow-up assessments at 3 and 6 months to monitor progress. The study is conducted across multiple centers in Canada to assess both clinical effectiveness and implementation potential.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have completed primary treatment for specific cancers within the last 24 months.

Not a fit: Patients with recurrent, refractory, or progressive cancer, or those planning to receive a transplant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life and functional outcomes for cancer survivors.

How similar studies have performed: Previous programs similar to CaRE@Home have shown positive outcomes in improving patient function and satisfaction, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

* 1\) Age 18 years or older
* 2\) Diagnosed with breast (stage 0-III), colorectal (stage I-III), head and neck (stage I-III), or lymphoma/lymphoproliferative disorder (excluded: recurrent, refractory, progressive, received or planning to receive transplant)
* 3\) Completed a primary treatment (i.e. surgery and/or radiation and/or systemic therapy of any kind) within the last 24 months
* 4\) If patients received systemic therapy of a fixed duration with adjuvant/curative intent, the main part should be completed, but patients are eligible if on primary, maintenance, or other adjuvant systemic therapy (e.g. eligible while on trastuzumab, immunotherapy, rituximab, oral endocrine or targeted therapy - ie ibrutinib). Indolent non-curative lymphoma patients are eligible if they have response to systemic therapy
* 5\) Communicate sufficiently in English to complete intervention and questionnaires
* 6\) Willing to be randomized and participate in the intervention and attend in-person or virtual assessments
* 7\) Internet access
* 8\) An indication for cancer rehabilitation (WHO-DAS score \>5).

Exclusion Criteria:

* 1\) Impaired functional status that would preclude rehabilitation (PRFS \>3)
* 2\) Indication of major depressive disorder (\> or = to 20 on PHQ-9)
* 3\) Diagnosis of neurological disease or condition significantly limiting cognitive functioning, such as language or memory (e.g., Alzheimer's disease or other dementia, severe traumatic brain injury);
* 4\) Currently enrolled in another personalized and supervised exercise or rehabilitation program
* 5\) Conditions or current injuries which are not appropriate for distance based exercise (based on intake screening questions and as determined by physician\*. \*In cases where patient's indicate an existing higher risk condition (i.e high blood pressure, recent heart attach or unstable angina, spinal cord compression, recent deep vein thrombosis) or injury, the study team will contact the physician for medical approval and clearance to participate in the study will be required)

Where this trial is running

Toronto, Ontario

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Jennifer Jones, PhD — UHN Princess Margaret Cancer Centre
• Study coordinator: charmaine silva, MSc

Conditions: Breast Cancer, Stage 0, Colorectal Cancer Stage I, Head and Neck Cancer Stage I, Lymphoma, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Colorectal Cancer Stage II