Rehabilitation program for patients with advanced cancer
Project 3 - Phase II, Preference Based, Randomized Controlled Trial of Group-Based, In Person Versus Virtual, Cancer Rehabilitation for People With Metastatic / Advanced Breast or Colorectal Cancers
This study is testing an 8-week rehab program for people with advanced breast or colorectal cancer to see if it helps them feel better and maintain their abilities, whether they join in-person or online.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05424068 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and effectiveness of the CaRE-Advanced Cancer (CaRE-AC) program, which is an 8-week rehabilitation intervention designed for individuals with advanced breast or colorectal cancer. Participants will be randomized to either an in-person or virtual rehabilitation group, focusing on maintaining functional abilities and improving quality of life. The program includes exercise classes and self-management skills training, addressing the unique needs of cancer survivors living with incurable conditions. The study aims to gather data on safety, acceptability, and efficacy to inform future larger-scale trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with locally advanced incurable or metastatic breast or colorectal cancer.
Not a fit: Patients who are wheelchair-bound or have severe pain or uncontrolled depressive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and functional status of patients with advanced cancer.
How similar studies have performed: Previous studies have shown promise in cancer rehabilitation approaches, but this specific program is novel and aims to fill existing gaps in care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Diagnosed with locally advanced incurable or metastatic breast or colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Fully independent with ambulation and transfers with or without ambulatory assistance * Palliative Performance score of \>70 (moderate predictive power estimating life expectancy \>6 months) * Receiving first or second line anti-cancer treatments in the metastatic / incurable setting (a relative proxy for expected survival \>6 months) * Medical clearance to participate from treating physician Exclusion Criteria: * Wheelchair level community ambulation * Moderate or severe non-cancer pain (\>6 out of 10 on visual analog scale) * Moderate or severe cancer bone pain (\>Gr 2 bone pain (i.e., moderate pain limiting instrumental ALDs or worse) as measured on CTCAE (see below)) * Severe or uncontrolled depressive symptoms (\>20 on PHQ-9) * Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations (e.g., dementia, traumatic brain injury, or brain metastasis influencing cognition or causing moderate-to-severe motor-sensory-coordination). Best determined by the referring physician or nurse practitioner. * Unable to communicate sufficiently in English to complete intervention, questionnaires, and consent. * Unwillingness to be randomized, participate in a group intervention, or attend individual physical assessments. * Inability to operate videoconferencing if preference is virtual programming.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jennifer Jones, PhD — University Health Network, Toronto
- Study coordinator: Charmaine Silva, MSc
- Email: charmaine.silva@uhn.ca
- Phone: 4165818453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.