Breast Cancer, Stage 0Colorectal Cancer Stage IHead and Neck Cancer Stage ILymphomaBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIColorectal Cancer Stage IIColorectal Cancer Stage IIIHead and Neck Cancer Stage IIHead and Neck Cancer Stage IIILymphoproliferative Disorders
Investigational drug(s) / intervention(s)
CaRE@Home intervention
CaRE@Home intervention: participants randomized to the intervention arm will complete a virtual 8 week exercise and education program.
Study summary
Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Disability — 6 months measured using the World Health Organization Disability Assessment Schedule 2.0, which is a cross-cultural standardized method for measuring limitations and restrictions on individuals' activities and participation in society. The average scores are comparable to the WHODAS 5-point scale, he total score for WHODAS ranges from 0-100, where a high score indicates major living limitations ((0-0.49) = none, mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4).
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Cancer Centre
Toronto
Ontario
Recruiting
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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