Status:

ACTIVE_NOT_RECRUITING

Rehabilitation for People With Advanced Cancer

Lead Sponsor:

University Health Network, Toronto

Conditions:

Advanced Breast Cancer

Advanced Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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.

Detailed Description

Cancer rehabilitation interventions that address common impairments and focus on maintaining or reducing the rate of functional decline are greatly needed for the growing population of cancer survivor...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 2 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 30 2026

Estimated Enrollment :

111 Patients enrolled

Trial Details

Trial ID

NCT05424068

Start Date

December 2 2022

End Date

January 30 2026

Last Update

December 3 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G2M9