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

Official title

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

Overview

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.

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 inte
• 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 e

Primary outcome measures

• 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.]

Secondary outcome measures (8)

• 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.]
• 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]
• 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.]
• Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire [Time frame: 12-weeks follow-up assessment.]
• Intervention Acceptability Measured Using the Treatment Acceptability and Preferences (TAP) Measure [Time frame: 12-weeks follow-up assessment.]
• Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire [Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.]
• 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.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Dartmouth-Hitchcock Clinic — Lebanon

Identifiers

NCT: NCT07706556 · STUDY02000934_2b · Dartmouth Cancer Center Pilot

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗