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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Anxiety

Demographics

Depression

+20 more

Other outcome measures

Measure of performance status

Performance Status

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,876 Total Patients Enrolled

54 Trials studying Breast Cancer

29,554 Patients Enrolled for Breast Cancer

Jennifer Jones, PhDPrincipal InvestigatorUniversity Health Network, Toronto

1 Previous Clinical Trials

388 Total Patients Enrolled

Media Library

In-person rehabilitation group Clinical Trial Eligibility Overview. Trial Name: NCT05424068 — N/A

Breast Cancer Research Study Groups: Standard best cancer practice, In-person Intervention arm, Virtual Intervention arm

Breast Cancer Clinical Trial 2023: In-person rehabilitation group Highlights & Side Effects. Trial Name: NCT05424068 — N/A

In-person rehabilitation group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424068 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate whether this clinical trial is currently accepting participants?

"This clinical trial, which was initially listed on December 2nd 2022, is presently seeking participants. The information posted to the site has been updated as recently as March 27th 2023."

Answered by AI

What are the key goals of this experiment?

"The primary outcome of this trial, assessed over a 6-month period will be the dropout rate as an indication of its efficacy. Secondary outcomes encompass physiological parameters such as cardiorespiratory fitness measured through the six minute walk test (6MWT), exercise intensity reflected in participants' rated perceived exertion (RPE) on a scale from 6 to 20, and health care utilisation determined by self-report questionnaires alongside assigned costs per service."

Answered by AI

How many participants are enrolled in this research project?

"Affirmative. The clinicaltrials.gov database shows that the search for trial participants is ongoing; it was initially posted on December 2nd 2022 and last updated on March 27th 2023. 117 patients are required to be enrolled from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rehabilitation for People With Advanced Cancer

2022. "Rehabilitation for People With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424068.