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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
charmaine silva, MSc
charmaine.silva@uhn.ca
4165818543
Backup
Jennifer Jones, PhD
jennifer.jones@uhn.ca
4165818603
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 388
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov