Pilot SMART of a Remotely Delivered, Adaptive Physical Activity Intervention for Breast Cancer Survivors

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-04-03

Completion

2027-06-03

Countries

• United States

Study Locations