A Randomized Two-Arm Proof of Concept Study Testing a Novel Approach to Exercise Promotion Based on Affect-regulation
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Core Exercise Promotion ProgramBehavioral: Effort-based exercise prescriptionBehavioral: Affect-based exercise prescription
- Registration Number
- NCT06258993
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
- ≥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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Effort-based Exercise Prescription (RPE-Rx) Effort-based exercise prescription - Affect-based Exercise Prescription (Affect-Rx) Core Exercise Promotion Program - Affect-based Exercise Prescription (Affect-Rx) Affect-based exercise prescription - Effort-based Exercise Prescription (RPE-Rx) Core Exercise Promotion Program -
- Primary Outcome Measures
Name Time Method Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up 6-weeks follow-up assessment. The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up 2-weeks follow-up assessment. The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up 12-weeks follow-up assessment. The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
- Secondary Outcome Measures
Name Time Method Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire 12-weeks follow-up assessment. An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.
Study Retention at 2-weeks Follow-up 2-weeks follow-up assessment. Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 6-weeks Follow-up 6-weeks follow-up assessment. Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 12-weeks Follow-up 12-weeks follow-up assessment. Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure 12-weeks follow-up assessment. A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.
Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire Baseline, 6-weeks follow-up, and 12-weeks follow-up. A 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.
Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat) Baseline, 6-weeks follow-up, and 12-weeks follow-up. A single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 6 (I did vigorous activities almost daily). Total scores range from 1-6. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.
Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form Baseline, 6-weeks follow-up, and 12-weeks follow-up. A 7-item self-report measure calculating the amount of health-related vigorous and moderate-intensity physical activity as well as sitting time performed by adult participants over a one-week period. The number of minutes per day participants report for 3 categories vigorous, moderate, and walking activities are multiplied by the average metabolic equivalent (METs) for each category (8.0 METs, 4.9 METs, and 3.3 METs, respectively). Scores for each category are summed to calculate a physical activity score for the past week quantified as total MET values. Higher METS demonstrate a higher total volume of physical activity completed in the prior week. MET values between 0-599 are considered "low active," MET values between 600-1499 are considered "moderately active," and MET values 1500 or higher are considered "High active." This measure also assesses participants' total sitting time in the past week. Total number of minutes reported for sitting time is not part of the physical activity
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Clinic
🇺🇸Lebanon, New Hampshire, United States