Recruiting

Step-Up Intervention

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07706556

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Affect-based Exercise Prescription

Effort-based exercise prescription

Standard Exercise Promotion Program

Step-up Exercise Promotion Program

Study Details

Brief summary:

The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform <150 minutes of MVPA at the 6-week data collection burst. Participants who performed <150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are:

1. What percentage of participants who are eligible for the intervention phase enroll in the intervention phase?
2. Will participants assigned to the "step-up" intervention pathway demonstrate equal or greater rates of study retention and intervention engagement relative to those assigned to the standard intervention arm?
3. What percentage of the sample is performing >150 minutes accelerometer measured MVPA/week at the intervention mid-point (week 6-data collection burst) and end-of-study (week 12-data collection burst)?
4. Do at least 50% of participants assigned to the "step-up" intervention pathway achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up?

All participants will:

  • Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
  • Participate in three meetings with the interventionist (an exercise specialist) 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 consecutive days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.

Some participants (those performing <150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.

Conditions

Breast Cancer

Study ID

NCT07706556

Start date

Jun 30, 2026

Status verified date

Aug, 2026

Completion date

Jun 3, 2027

Anticipated

Primary completion date

Apr 3, 2027

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

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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.

Standard Exercise Promotion Program

Core intervention content will be delivered during the Visit 1, 1-month, and 2-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 for all participants. 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.

Step-up Exercise Promotion Program

Core intervention content will be delivered during check-in meetings scheduled during study weeks 7, 8, 9, and 10. During these visits, the interventionist will work with the participant to set weekly goals and problem-solving barriers to action. All participants will continue to receive instructions to follow their assigned exercise prescription (Affect-based Exercise Prescription or Effort-based exercise prescription). The step-up intervention calls are delivered the same regardless to which exercise prescription format the participant is assigned.

Primary outcome measure

  • Rate of Intervention Enrollment [ Time Frame: Baseline assessment. ]
  • Study Retention at 6-weeks Follow-up [ Time Frame: 6-weeks follow-up assessment. ]
  • Study Retention at 12-weeks Follow-up [ Time Frame: 12-weeks follow-up assessment. ]
  • Intervention Engagement [ Time Frame: 12-weeks follow-up assessment. ]

Central Contacts and Locations

Central contacts

Courtney J Stevens, PhD

6036509643courtney.j.stevens@dartmouth.edu

Aislinn 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

Aug 31, 2026

Last verified

Aug, 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 2026-08-31.