Rehabilitation for People With Advanced Cancer

Last updated: October 9, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer Treatment

Colorectal Cancer

Treatment

In-person rehabilitaiton group

Virtual rehabilitation group

Clinical Study ID

NCT05424068
21-5539
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ambulatoryassistance

  • Palliative Performance score of >70 (moderate predictive power estimating lifeexpectancy >6 months)

  • Receiving first or second line anti-cancer treatments in the metastatic / incurablesetting (a relative proxy for expected survival >6 months)

  • Medical clearance to participate from treating physician

Exclusion

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 limitinginstrumental 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 orappropriate engagement with self-management and exercise recommendations (e.g.,dementia, traumatic brain injury, or brain metastasis influencing cognition orcausing moderate-to-severe motor-sensory-coordination). Best determined by thereferring 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 attendindividual physical assessments.

  • Inability to operate videoconferencing if preference is virtual programming.

Study Design

Total Participants: 117
Treatment Group(s): 2
Primary Treatment: In-person rehabilitaiton group
Phase:
Study Start date:
December 02, 2022
Estimated Completion Date:
May 30, 2025

Study 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 survivors living with incurable or metastatic cancer. In the curative setting, the main gaps in care include lack of referral and barriers to access care; however, in the metastatic setting, high quality evidence on safety, acceptability, and efficacy is still required. In response, based on the results of a need assessments (n=50) of this population and input from palliative care experts, we recently developed the CaRE-Advanced Cancer (CaRE-AC) program. Similar to CaRE@ELLICSR, CaRE-AC is an 8-week multidimensional, group-based program with exercises classes and selfmanagement skills teaching. A single-arm phase I pilot of this program is currently being conducted to assess the feasibility and acceptability (Co-PIs Jones/Langelier). To date, 14 patients have enrolled and 9 patients have completed the program (64%). All participants reported feeling the program was safe and 90% were satisfied with the structure and content.

Data collection is expected to be complete be the end of 2019 and the findings will inform revisions to the program format and content. To build on this work, Project Three is a Phase II feasibility RCT of the CaRE-AC program. Results will inform the development of a multicentre pragmatic RCT protocol.

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

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