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NCT05898789From ClinicalTrials.govRecruiting

Virtual Rehabilitation for Cancer Survivors

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

  • 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

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University Health Network, Toronto
Enrolment target
388
Started
7 July 2023
Main results due
30 September 2028
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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)

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05898789. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Virtual Rehabilitation for Cancer Survivors | Trialion