Clinical trial · Interventional
Rehabilitation for People 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
NCT05424068CI-TRIAL-00103984completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The proposed study is a Phase II, feasibility, randomized controlled preference based study. This will be conducted in Vancouver and Toronto and includes breast and colorectal cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cancer Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-person rehabilitaiton group | Behavioral | — | UNRESOLVED |
| Virtual rehabilitation group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Standard best cancer practice
- description
- All participants (intervention arms 1 and 2, and control) will receive usual oncology care by their health care providers which includes recommendations for general aerobic and resistance exercise. Participants in the control group will be of recommended to work towards the recommended 90 minutes moderate to vigorous aerobic exercise, and two days a week of large muscle group strength training as recommended by the ACSM. A general brochure will be provided to all control participants providing education in line with current standard of care. This safety precautions noted these will be indicated brochure will have an open text field on the back which will allow the kinesiologist to provide and general advice at each time point. If there are particular here. Participants in all study arms may also be referred by treating health care providers to usual supportive care or early palliative care services at any time deemed necessary, and will be recorded as part of monthly data collection.
- type
- EXPERIMENTAL
- label
- In-person Intervention arm
- description
- The in-person intervention arm is an 8-week program and four week short maintenance period. This includes 1 hr of in-person, group-based exercise guided by a qualified exercise professional followed by 1 hr of in-person, group based, self-management education provided by a rehabilitation expert to occur immediately following the exercise session. Each participant is given a FitBit® to track steps, heart rate and sleep. Each site (i.e., Toronto and Vancouver) will run independent, in-person exercise and educational programs based on local referrals. Self management sessions include 8 high priority topics for advanced cancer patients including: 1) goal setting, 2) managing pain, 3) reducing fatigue and improving sleep, 4) boosting brain health, 5) eating and cooking for wellness, 6) managing emotions, 7) being mindful, and 8) planning for the future. Education sessions will be run by local experts at each site.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.