Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06258993

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here