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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA259632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
All participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affect-based Exercise Prescription (Affect-Rx) | Experimental |
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| Effort-based Exercise Prescription (RPE-Rx) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Exercise Promotion Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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 | 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. | 12-weeks follow-up assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks follow-up assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12-weeks follow-up assessments. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney J Stevens, PhD | Contact | 6036509643 | courtney.j.stevens@dartmouth.edu | |
| Aislinn E Mitcham, BA | Contact | 6036466545 | aislinn.e.mitcham@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Courtney J Stevens, PhD | Dartmouth-Hitcock Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Clinic | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| 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. |
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| 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. |
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| 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. | 2-weeks follow-up 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. |
| Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure | 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. | 12-weeks follow-up assessment. |
| Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire | 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. | 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) | 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. | Baseline, 6-weeks follow-up, and 12-weeks follow-up. |
| Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form | 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 | Baseline, 6-weeks follow-up, and 12-weeks follow-up. |
| 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. | Baseline and 12-weeks follow-up assessments. |
| 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. | Baseline and 12-weeks follow-up assessments. |
| 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. | Baseline and 12-weeks follow-up assessments. |
| Change Overtime in Depressive Symptoms using The PROMIS Depression 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 depressive symptoms. | Baseline and 12-weeks follow-up assessments. |
| Change Overtime in Sleep Disturbance using The PROMIS Sleep Disturbance Scale | 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. | Baseline and 12-weeks follow-up assessments. |
| Change Overtime in Intentions for Exercise Measured Using The Exercise Intentions Scale | 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. | Baseline, 6-weeks follow-up, and 12-weeks follow-up. |
| Change Overtime in Physical Activity Enjoyment using the Physical Activity Enjoyment Scale-Short form (PACE-S) | 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. | Baseline, 6-weeks follow-up, and 12-weeks follow-up. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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