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Rehabilitation for Breast and Colorectal Cancer

N/A

Recruiting

Led By Jennifer Jones, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fully independent with ambulation and transfers with or without ambulatory assistance

Diagnosed with locally advanced incurable or metastatic breast or colorectal cancer

Must not have

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)

Severe or uncontrolled depressive symptoms (>20 on PHQ-9)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare two treatments for breast and colorectal cancer in Vancouver & Toronto to decide which is better.

Who is the study for?

This trial is for adults over 18 with advanced, incurable breast or colorectal cancer who can walk and take care of themselves. They should be on their first or second treatment in the metastatic setting and expected to live more than 6 months. People in wheelchairs, with severe depression, unwilling to participate fully, unable to use video calls (for virtual rehab), not fluent in English, suffering from significant pain or cognitive issues affecting safety are excluded.

What is being tested?

The study compares two types of rehabilitation programs for people with advanced cancer: one that's done in person and another that's conducted virtually. Participants will be randomly assigned to a group based on their preference and will receive either face-to-face sessions or online guidance aimed at improving their physical function.

What are the potential side effects?

Since this trial focuses on rehabilitation rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and move around on my own, with or without help like a cane.

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My breast or colorectal cancer is advanced and cannot be cured with surgery.

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any brain conditions affecting my thinking or movement.

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I have severe depression symptoms.

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I experience moderate to severe pain from cancer in my bones.

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I am willing to be randomized, join group activities, and go to personal health checks.

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I use a wheelchair for getting around in the community.

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I cannot use video calls for virtual meetings.

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My pain level is more than 6 out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

Anxiety

Demographics

Depression

+20 more

Other study objectives

Measure of performance status

Performance Status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Intervention armExperimental Treatment1 Intervention

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.

Group II: In-person Intervention armExperimental Treatment1 Intervention

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.

Group III: Standard best cancer practiceActive Control1 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.

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