Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
NCT Number: NCT06258993
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Core 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.
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.
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.
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.
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.
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.
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.
Time frame: 2-weeks follow-up assessment.
Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
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.
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.
Time frame: 12-weeks follow-up assessment.
A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription 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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Aislinn E Mitcham, BA
CONTACT
Courtney J Stevens, PhD
CONTACT
Dartmouth-Hitchcock Medical Center
Other
Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation (Study 2)
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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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