Recruiting

Affect-based & Effort-based

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06258993

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Core Exercise Promotion Program

Affect-based exercise prescription

Effort-based exercise prescription

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06258993

Start date

Apr 16, 2024

Status verified date

Jun, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Affect-based Exercise Prescription (Affect-Rx)

active comparator: Effort-based Exercise Prescription (RPE-Rx)

Interventions

Core Exercise Promotion Program

Core intervention content will be delivered during the Visit 1 and 1-Month-Check-in meetings. Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed. All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same across both conditions. All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines. All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.

Affect-based exercise prescription

Participants assigned to Affect-Rx will receive instructions to "select a pace of exercise that makes you feel as good as possible." The exercise intensity prescription section of their exercise plan will include the Feeling Scale as an attachment and participants will be given the instruction to "stay in the green zone" on the Feeling Scale.

Effort-based exercise prescription

Participants assigned to RPE-Rx will receive instructions to "select a pace that would make it challenging for you to carry on more than a short conversation." The exercise intensity prescription section of their exercise plan will include the Rating of Perceived Exertion (RPE) scale as an attachment and participants will be given the instruction to "stay in the green zone" on the RPE Scale.

Primary outcome measure

  • Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up [ Time Frame: 2-weeks follow-up assessment. ]
  • Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up [ Time Frame: 6-weeks follow-up assessment. ]
  • Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up [ Time Frame: 12-weeks follow-up assessment. ]

Central Contacts and Locations

Central contacts

Courtney J Stevens, PhD

6036509643courtney.j.stevens@dartmouth.edu

Aislinn E Mitcham, BA

6036466545aislinn.e.mitcham@hitchcock.org

Locations

Dartmouth-Hitchcock Clinic

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Courtney J Stevens, PhD

603-646-5451courtney.j.stevens@dartmouth.edu

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-06-23.