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NCT Number: NCT07706556

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Courtney J Stevens, PhD

CONTACT

[email protected]

603-646-5451

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Rate of Intervention Enrollment

    Time frame: Baseline assessment.

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

  2. Study Retention at 6-weeks Follow-up

    Time frame: 6-weeks follow-up assessment.

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

  3. Study Retention at 12-weeks Follow-up

    Time frame: 12-weeks follow-up assessment.

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

  4. Intervention Engagement

    Time frame: 12-weeks follow-up assessment.

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

Secondary outcomes

  1. Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up

    Time frame: Time Frame: 2-weeks follow-up assessment.

    The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  2. Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up.

    Time frame: Time Frame: 6-weeks follow-up assessment

    The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  3. Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up

    Time frame: [Time Frame: 12-weeks follow-up assessment.

    The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  4. Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire

    Time frame: 12-weeks follow-up assessment.

    An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.

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

    Time frame: 12-weeks follow-up assessment.

    A 4-item self-report questionnaire used to measure intervention acceptability using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.

  6. Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire

    Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.

    A 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.

  7. Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)

    Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.

    A single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 6 (I did vigorous activities almost daily). Total scores range from 1-6. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.

  8. Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form

    Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.

    A 7-item self-report measure calculating the amount of health-related vigorous and moderate-intensity physical activity as well as sitting time performed by adult participants over a one-week period. The number of minutes per day participants report for 3 categories vigorous, moderate, and walking activities are multiplied by the average metabolic equivalent (METs) for each category (8.0 METs, 4.9 METs, and 3.3 METs, respectively). Scores for each category are summed to calculate a physical activity score for the past week quantified as total MET values. Higher METS demonstrate a higher total volume of physical activity completed in the prior week. MET values between 0-599 are considered "low active," MET values between 600-1499 are considered "moderately active," and MET values 1500 or higher are considered "High active." This measure also assesses participants' total sitting time in the past week. Total number of minutes reported for sitting time is not part of the physical activity

Other outcomes

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

    Time frame: Baseline and 12-weeks follow-up assessments.

    An 8-item self-report measure with response options ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging from 1 (never) to 5 (always) over the past 7 days. Total scores range from 8 - 40. Higher scores reflect more fatigue.

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

    Time frame: Baseline and 12-weeks follow-up assessments.

    A 10-item self-report measure with response options ranging from 1 (poor/never/not at all) to 5 (excellent/completely/always) for items 1-9 and 0 (no pain) to 10 (worst pain imaginable) for the item 10. Total scores range from 9 - 45. Higher scores represent better health-related quality of life.

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

    Time frame: Baseline and 12-weeks follow-up assessments.

    An 8-item self-report measure with response options ranging from 1 (unable to do) to 5 (without any difficulty) and the degree to which health limits specific activities on a scale from 1 (cannot do) to 5 (not at all). Total scores range from 8 - 40. Higher scores reflect better physical function.

  4. Change Overtime in Anxiety measured using The PROMIS Anxiety Form

    Time frame: Baseline and 12-weeks follow-up assessments.

    An 8-item self-report measure with response options ranging from 1 (never) to 5 (always). Total scores range from 8 - 40. Higher scores reflect higher levels of anxiety.

  5. Change Overtime in Depressive Symptoms using The PROMIS Depression Form

    Time frame: Baseline and 12-weeks follow-up assessments.

    An 8-item self-report measure with response options ranging from 1 (never) to 5 (always). Total scores range from 8 - 40. Higher scores reflect higher levels of depressive symptoms.

  6. Change Overtime in Sleep Disturbance using The PROMIS Sleep Disturbance Scale

    Time frame: Baseline and 12-weeks follow-up assessments.

    An 8-item self-report measure with response options indicating the level of sleep disturbance a participant may experience. The first question asks about sleep quality and ranges from 1 (very good) to 5 (very poor). Questions 2-8 further inquire about the specifics of the sleep experience, ranging from 1 (not at all) to 5 (very much). Total scores range from 8 - 40. Higher scores reflect a greater degree of sleep disturbance or poorer quality of sleep.

  7. Change Overtime in Intentions for Exercise Measured Using The Exercise Intentions Scale

    Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.

    A 5-item self-report measure of intentions to exercise in the next week. Response options range from 1 (not at all likely) to 7 (very likely). Responses are summed and then averaged; total scores range from 1-7. Higher scores represent stronger intentions to exercise in the next week.

  8. Change Overtime in Physical Activity Enjoyment using the Physical Activity Enjoyment Scale-Short form (PACE-S)

    Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.

    A 4-item self-report measure with response options ranging from 1 (Strongly disagree) to 5 (Strongly agree). Total scores range from 4 - 20. Higher scores reflect higher levels of pleasure when performing physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Aislinn Mitcham, BA

CONTACT

[email protected]

6036466545

Courtney J Stevens, PhD

CONTACT

[email protected]

6036509643

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART) of a Remotely Delivered, Adaptive Physical Activity Intervention for Breast Cancer Survivors

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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