The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are:
1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription.
All participants will:
* Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in two meetings with a member of the study team 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 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
≥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
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)
Parallel
Core Exercise Promotion Program
BehavioralCore intervention content will be delivered during the Visit 1 and 1-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 across both conditions. 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
BehavioralParticipants 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
BehavioralParticipants 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
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.
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
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.
Study Retention at 2-weeks Follow-up
Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
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.
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.
Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a
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.
Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale
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.
Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a
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.
Change Overtime in Anxiety measured using The PROMIS Anxiety Form
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.
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Dartmouth-Hitchcock Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
