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

NCT07706556 | Recruiting DMC

• 2 other identifiers: STUDY02000934_2bDartmouth Cancer Center Pilot
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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:

• 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

Outcome Measures

Primary Outcomes (4)

• Rate of Intervention Enrollment

  Number of participants who enroll in the intervention phase out of the number of participants who are eligible for the intervention phase

  Baseline assessment.

• Study Retention at 6-weeks Follow-up

  Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.

  6-weeks follow-up assessment.

• Study Retention at 12-weeks Follow-up

  Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.

  12-weeks follow-up assessment.

• Intervention Engagement

  Number of intervention sessions completed out of the number of intervention sessions scheduled

  12-weeks follow-up assessment.

Secondary Outcomes (8)

• 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.

• Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire

  12-weeks follow-up assessment.

• Intervention Acceptability Measured Using the Treatment Acceptability and Preferences (TAP) Measure

  12-weeks follow-up assessment.

Other Outcomes (8)

• Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a

  Baseline and 12-weeks follow-up assessments.

• Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale

  Baseline and 12-weeks follow-up assessments.

• Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a

  Baseline and 12-weeks follow-up assessments.

Study Arms (4)

Effort-based Exercise Prescription (RPE-Rx) Standard

ACTIVE COMPARATOR

Behavioral: Standard Exercise Promotion Program

Affect-based Exercise Prescription (Affect-Rx) Standard

EXPERIMENTAL

Behavioral: Affect-based Exercise Prescription; Behavioral: Standard Exercise Promotion Program

Effort-based Exercise Prescription (RPE-Rx) Step-Up

ACTIVE COMPARATOR

Behavioral: Effort-based exercise prescription; Behavioral: Standard Exercise Promotion Program; Behavioral: Step-up Exercise Promotion Program

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

EXPERIMENTAL

Behavioral: Affect-based Exercise Prescription; Behavioral: Standard Exercise Promotion Program; Behavioral: Step-up Exercise Promotion Program

Interventions

Affect-based Exercise Prescription BEHAVIORAL

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.

Affect-based Exercise Prescription (Affect-Rx) Standard; Affect-based Exercise Prescription (Affect-Rx) Step-Up

Effort-based exercise prescription BEHAVIORAL

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.

Effort-based Exercise Prescription (RPE-Rx) Step-Up

Standard Exercise Promotion Program BEHAVIORAL

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.

Affect-based Exercise Prescription (Affect-Rx) Standard; Affect-based Exercise Prescription (Affect-Rx) Step-Up; Effort-based Exercise Prescription (RPE-Rx) Standard; Effort-based Exercise Prescription (RPE-Rx) Step-Up

Step-up Exercise Promotion Program BEHAVIORAL

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.

Affect-based Exercise Prescription (Affect-Rx) Step-Up; Effort-based Exercise Prescription (RPE-Rx) Step-Up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Courtney J Stevens, PhD

CONTACT

6036509643; courtney.j.stevens@dartmouth.edu

Aislinn Mitcham, BA

CONTACT

6036466545; aislinn.e.mitcham@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)