A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation
Recruiting · NCT06258993 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed across 1 US state.
- Dartmouth-Hitchcock Clinic - Lebanon, New Hampshire, United States