Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT05424068
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05424068
Study Brief:
Protocol Section:
NCT05424068