Recruiting

Virtual Rehabilitation

Sponsor:

University Health Network, Toronto

Code:

NCT05898789

Conditions

Breast Cancer, Stage 0

Colorectal Cancer Stage I

Head and Neck Cancer Stage I

Lymphoma

Breast Cancer Stage I

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CaRE@Home intervention

Study Details

Brief 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.

Conditions

Breast Cancer, Stage 0

Colorectal Cancer Stage I

Head and Neck Cancer Stage I

Lymphoma

Breast Cancer Stage I

Study ID

NCT05898789

Start date

Jul 7, 2023

Status verified date

Feb, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

388 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CaRE@Home intervention

Individualized exercise plans are created from baseline assessments and progressed toward ACSM targets: moderate aerobic activity 3×/week for 30 minutes and resistance training 2×/week. Plans are updated at check-ins and delivered through Physitrack®, with print copies if needed.

Fitbit™ devices monitor activity, sleep, and heart rate. Participants receive instructions, share data with clinicians, and wear the device for the full study. Data syncs to the clinician dashboard to guide weekly check-ins, with setup support provided.

Participants complete nine online CaRE@Home modules on wellness, fatigue, emotions, mindfulness, cognition, connection, and future planning. Modules use behavior-change strategies, were developed by a multidisciplinary team, and remain accessible through the 3-month maintenance period.

Weekly remote coaching (weeks 2-7) plus two follow-up calls offer tailored feedback, goal-setting, and motivational interviewing to support adherence.

no intervention: Usual Care group

Control-arm participants receive usual oncology care. They are given general exercise recommendations aligned with ACSM guidelines and a brochure that includes space for the kinesiologist to add safety notes or general advice at each assessment. Referrals to supportive care services may occur at any time and will be recorded monthly.

After the T3 assessment, UC participants may opt into the CaRE@Home program without additional study measures beyond what is needed for exercise prescription. They may complete the 8-week e-module program, receive check-in calls during weeks 2-7 plus 1- and 2-month maintenance calls, and attend physical assessments at the end of the 8-week program and 3 months later.

Interventions

CaRE@Home intervention

participants randomized to the intervention arm will complete a virtual 8 week exercise and education program.

Primary outcome measure

  • Disability [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

charmaine silva, MSc

4165818543charmaine.silva@uhn.ca

Jennifer Jones, PhD

4165818603jennifer.jones@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

charmaine silva, MSc

4165818543charmaine.silva@uhn.ca

Jennifer Jones, PhD

4165818603jennifer.jones@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-02-25.