A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based … (NCT06258993) | Clinical Trial Compass
RecruitingNot Applicable
A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation
United States85 participantsStarted 2024-04-16
Plain-language summary
The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are:
1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up?
2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription.
3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription.
All participants will:
* Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
* Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants.
* Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years old
* Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer
* \<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months
* Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods
* Willing to wear the ActiGraph monitor during assessment periods
* Access to internet to complete REDCap survey assessments
Exclusion Criteria:
* Non-English speaking/not able to read English
* Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
* Currently pregnant
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
* Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8)
* Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
* Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
Timeframe: 2-weeks follow-up assessment.
2
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
Timeframe: 6-weeks follow-up assessment.
3
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up