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Behavioural Intervention

Behaviour Change for Cancer Survivors (BOOST-Up Trial)

N/A

Recruiting

Led By Linda Trinh, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

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

Must have

* ≥18 years of age

* Confirmed diagnosis of cancer of any type (Stages I to III; localized)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t0 (baseline), t1 (mid-point), t2 (post-intervention 6-months), t3 (6-month follow up after intervention), t4 (1-year follow up after intervention)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare the effects of a virtual 6-month exercise program with standard counseling to a supervised exercise program with behavioral counseling on physical activity levels in cancer survivors. The study will also include follow-up

Who is the study for?

This trial is for adults over 18 who've had cancer surgery at least 12 weeks ago, are in stages I-III of any cancer type, and finished radiation treatment at least 6 weeks prior. Participants should be physically inactive but able to walk with minimal aid, have internet access, speak English, and own a device capable of videoconferencing.

What is being tested?

The study compares two programs: one combines standard exercise counseling with a virtual physical activity (PA) program; the other adds motivationally-enhanced behavioral counseling to PA. The goal is to increase moderate to vigorous physical activity in cancer survivors following evidence-based guidelines.

What are the potential side effects?

Since this trial involves exercise and counseling interventions rather than medication or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is confirmed and is in stages I to III, not spread widely.

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It has been at least 12 weeks since my last surgery.

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It has been over 6 weeks since my last radiation treatment.

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I can walk daily with little to no help from devices.

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I do not have serious heart conditions like unstable angina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t0 (baseline), t1 (mid-point), t2 (post-intervention 6-months), t3 (6-month follow up after intervention), t4 (1-year follow up after intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t0 (baseline), t1 (mid-point), t2 (post-intervention 6-months), t3 (6-month follow up after intervention), t4 (1-year follow up after intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t0 (baseline), t1 (mid-point), t2 (post-intervention 6-months), t3 (6-month follow up after intervention), t4 (1-year follow up after intervention) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Moderate-to-Vigorous Physical Activity

Secondary study objectives

30-s Chair Stand Test

6-Minute Walk Test

Age

+15 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Activity + Behavioural Counselling (PA + BC)Experimental Treatment1 Intervention

The PA+BC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive behavioural counselling support sessions with a QEP every two weeks during the intervention period (12 total). The focus of these sessions will incorporate tailored behaviour change content from the M-PAC framework. At the end of the 6-month program, an individualized PA prescription will be provided based on their fitness level (adjusted throughout) to continue achieving the PA goal for the 6-month post intervention and 1-year post intervention follow-up.

Group II: Physical Activity + Exercise Couselling (PA + EC)Active Control1 Intervention

The PA+EC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive the same frequency of group-based and 1:1 counseling support sessions via Zoom as PA+BC participants. The focus of these sessions will be on exercise training principles for proper PA technique, how to monitor intensity, and progress PA safely to achieve the PA guidelines. The support sessions will be 30-45 minutes and delivered via Zoom each week in either group or 1:1 format depending on the topic.

0 / 6Eligibility criteria met