Rehabilitation for People With Advanced Cancer

NCT05424068 | Completed

• 1 other identifier: 21-5539
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer; Advanced Colorectal Cancer; Cancer Rehabilitation

Keywords

Cancer Rehabilitation; Virtual Cancer Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Drop-out rates as a measure of feasibility (demand/update of intervention)

  Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervention.

  6 months

• Patient preference as assessed during clinical support as a measure of feasibility (acceptability)

  Check-ins with Kinesiologist during assessments will be used to identify intervention acceptability/preference.

  6 months

• Measuring safety/practicality as assessed during one-on-one with the health coach (analyzed as qualitative data)

  Completed over MS Teams/in-person and will be a conversational question and answer format.

  6 months

Secondary Outcomes (23)

• Demographics

  6 months

• Disability

  6 months

• Physical functioning

  6 months

• Social functioning

  6 months

• Depression

  6 months

Other Outcomes (2)

• Performance Status

  6 months

• Measure of performance status

  6 months

Study Arms (3)

Standard best cancer practice

NO INTERVENTION

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.

In-person Intervention arm

EXPERIMENTAL

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.

Behavioral: In-person rehabilitaiton group

Virtual Intervention arm

EXPERIMENTAL

The virtual intervention arm will be an 8-week program plus four week short maintenance period but will include two separate 1 hour sessions per week. This includes: 1) 60 minutes of virtual, group-based, synchronous exercise over a virtual secure platform; and, 2) A separate 60 min virtual synchronous education session provided on a separate day (to prevent virtual fatigue). 3) Encouragement to participate in a home program the other days of the week, striving for the recommended 90 min of moderate to vigorous aerobic exercise and 2 days of week or resistance exercise. The virtual intervention group will combine participants across both study locations and run sessions when sufficient numbers are recruited. Self-management education content will be unchanged to the in-person sessions but conducted over a virtual platform (i.e., videoconferencing) with participants also attending virtually.

Behavioral: Virtual rehabilitation group

Interventions

In-person rehabilitaiton group BEHAVIORAL

participants who have chosen to complete the study intervention by coming in for their 8 week education and exercise sessions.

In-person Intervention arm

Virtual rehabilitation group BEHAVIORAL

Participants who have chosen to complete the study virtually instead of in-person sessions.

Virtual Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

Study Officials

• Jennifer Jones, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: June 21, 2022
• Study Start: December 2, 2022
• Primary Completion: July 30, 2025
• Study Completion: January 16, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CA (1)