Actively Recruiting
A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-05-08
85
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Completed primary cancer treatment for Stage 0-III breast cancer within the last 5 years
- Currently engage in less than 60 minutes per week of moderate to vigorous physical activity with no major changes in the past 6 months
- Own an Android or iPhone smartphone or tablet and willing to use it for app-based surveys
- Willing to wear the ActiGraph activity monitor during assessment periods
- Have internet access to complete REDCap survey assessments
You will not qualify if you...
- Not able to read or speak English
- Have major exercise contraindications based on the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+
- Currently pregnant
- History of severe mental illness or currently taking mood stabilizing medications such as antipsychotics, anticonvulsants, or lithium
- Have moderate to severe depressive symptoms (score of 10 or higher on the Patient Health Questionnaire-8)
- Have moderate to severe cognitive impairment (score less than 3 on a 6-item cognitive screener)
- Have clinically significant substance use (score of 2 or higher on the CAGE-AID screener)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
C
Courtney J Stevens, PhD
CONTACT
A
Aislinn E Mitcham, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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