Virtual Rehabilitation for Cancer Survivors

NCT05898789 | Recruiting

• 1 other identifier: 22-6035
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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; Breast Cancer Stage II; Breast Cancer Stage III; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Head and Neck Cancer Stage II; Head and Neck Cancer Stage III; Lymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

• Disability

  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).

  6 months

Secondary Outcomes (14)

• Demographics

  6 months

• Physical functioning

  8 months

• Social functioning

  8 months

• Anxiety

  8 months

• Physical activity

  8 months

Study Arms (2)

CaRE@Home intervention

EXPERIMENTAL

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.

Behavioral: CaRE@Home intervention

Usual Care group

NO INTERVENTION

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 BEHAVIORAL

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

CaRE@Home intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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 (excluded: recurrent, refractory, progressive, received or planning to receive transplant)
• \) Completed a primary treatment (i.e. surgery and/or radiation and/or systemic therapy of any kind) within the last 24 months
• \) 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
• \) Communicate sufficiently in English to complete intervention and questionnaires
• \) Willing to be randomized and participate in the intervention and attend in-person or virtual assessments
• \) Internet access
• \) An indication for cancer rehabilitation (WHO-DAS score \>5).

You may not qualify if:

• \) Impaired functional status that would preclude rehabilitation (PRFS \>3)
• \) Indication of major depressive disorder (\> or = to 20 on PHQ-9)
• \) 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);
• \) Currently enrolled in another personalized and supervised exercise or rehabilitation program
• \) 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ; Colorectal Neoplasms; Head and Neck Neoplasms; Lymphoma; Breast Neoplasms; Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jennifer Jones, PhD

  UHN Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

charmaine silva, MSc

CONTACT

4165818543; charmaine.silva@uhn.ca

Jennifer Jones, PhD

CONTACT

4165818603; jennifer.jones@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 12, 2023
• Study Start: July 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CA (1)