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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 purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affect-regulated exercise prescription | Experimental | Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Exercise Promotion Intervention | Behavioral | Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Sample With Valid Accelerometer Data at Baseline | The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%. | Baseline assessment |
| Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%. | 2-weeks follow-up assessment |
| Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%. | 6-weeks follow-up assessment |
| Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%. | 12-weeks follow-up assessment |
| Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 | Affiliation | Role |
|---|---|---|
| Courtney J Stevens, PhD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Clinic | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40736469 | Derived | Stevens CJ, Bobak CA, Morrissette KJ, Thompson RC, Lyons KD, Wallace GM, Emerson AJ, Conroy DE, Williams DM, Chamberlin MD, Bruce ML. Exercise That Feels as Good as Possible: Acceptability of an Affect-Based Exercise Prescription Among Stage 0-III Breast Cancer Survivors. Psychooncology. 2025 Aug;34(8):e70225. doi: 10.1002/pon.70225. |
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1 participant signed consent but did not engage in any reach activities and no data was collected for this individual.
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| ID | Title | Description |
|---|---|---|
| FG000 | Affect-regulated Exercise Prescription | Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible." Core Exercise Promotion Intervention: Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Affect-regulated Exercise Prescription | Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible." Core Exercise Promotion Intervention: Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-weeks follow-up assessment |
|
15 weeks. After participants initially enroll in the study there is often a period of a week or more before they can be scheduled for their intervention orientation meeting. The intervention portion of the study last 12 weeks. Often it takes a week or more before participants can be scheduled for their exit interview after the end of the 12 week intervention. Thus, participants are assessed for a period of approximately 15 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Affect-regulated Exercise Prescription | Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible." Core Exercise Promotion Intervention: Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney J. Stevens, PhD, Principal Investigator | Dartmouth-Hitchcock Medical Center | 603-650-9643 | courtney.j.stevens@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Jul 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2021 | Jul 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants. |
| Baseline through 12-weeks follow-up assessments |
| Number of Participants Who Completed the Exit Interview | Semi-structured interview to assess participants' perceptions regarding their experience participating in the study. | 12-weeks follow-up assessment |
| 12-weeks follow-up assessment |
| 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 |
| 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 |
| 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 |
| Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | 2-weeks follow-up assessment |
| Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | 6-weeks follow-up assessment |
| Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | 12-weeks follow-up assessment |
| 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 |
| 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 and 12-weeks follow-up assessments |
| 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 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month. | Baseline and 12-weeks follow-up assessments |
| Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale | A 5-item self-report measure of intentions to engage in physical activity. 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 engage in physical activity. | Baseline and 12-weeks follow-up assessments |
| Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale | A 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise. | Baseline and 12-weeks follow-up assessments |
| Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2) | A 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise. | Baseline and 12-weeks follow-up assessments |
| Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale | A 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise. | Baseline and 12-weeks follow-up assessments |
| Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale | A 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise. | Baseline and 12-weeks follow-up assessments |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Sample With Valid Accelerometer Data at Baseline | The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%. | Two of the N = 37 participants enrolled at baseline withdrew before starting accelerometer data collection. Thus, accelerometer data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure). | Posted | Count of Participants | Participants | Baseline assessment |
|
|
|
| Primary | Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%. | Posted | Count of Participants | Participants | 2-weeks follow-up assessment |
|
|
|
| Primary | Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%. | Posted | Count of Participants | Participants | 6-weeks follow-up assessment |
|
|
|
| Primary | Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%. | Posted | Count of Participants | Participants | 12-weeks follow-up assessment |
|
|
|
| Primary | Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion | The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants. | Two of the N = 37 participants enrolled at baseline withdrew before starting EMA data collection. Thus, EMA data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure). | Posted | Number | percentage of EMA prompts completed | Baseline through 12-weeks follow-up assessments |
|
|
|
| Primary | Number of Participants Who Completed the Exit Interview | Semi-structured interview to assess participants' perceptions regarding their experience participating in the study. | Participants who completed the exit interview | Posted | Number | participants | 12-weeks follow-up assessment |
|
|
|
| Secondary | 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. | Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 12-weeks follow-up. N = 28 participants had valid wear time at 12-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | minutes of daily MVPA | 12-weeks follow-up assessment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-weeks follow-up assessment |
|
|
|
| Secondary | 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. | Posted | Number | participants | 2-weeks follow-up assessment |
|
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|
| Secondary | 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. | Posted | Number | participants | 6-weeks follow-up assessment |
|
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| Secondary | 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. | Posted | Number | participants | 12-weeks follow-up assessment |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | Data was missing from N = 1 participant, total sample size at 2 weeks follow up was N = 30. | Posted | Mean | Standard Deviation | minutes per day | 2-weeks follow-up assessment |
|
|
|
| Other Pre-specified | Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | Posted | Mean | Standard Deviation | minutes per day | 6-weeks follow-up assessment |
|
|
|
| Other Pre-specified | Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up | The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated. | Posted | Mean | Standard Deviation | minutes per day | 12-weeks follow-up assessment |
|
|
|
| Other Pre-specified | 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. | Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 2-weeks follow-up. N = 28 participants had valid wear time at 2-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | minutes of daily MVPA | 2-weeks follow-up assessment |
|
|
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| Other Pre-specified | 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. | Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 6-weeks follow-up. N = 28 participants had valid wear time at 6-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | minutes of daily MVPA | 6-weeks follow-up assessment |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | 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 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
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|
|
| Other Pre-specified | Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale | A 5-item self-report measure of intentions to engage in physical activity. 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 engage in physical activity. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale | A 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
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|
|
| Other Pre-specified | Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2) | A 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale | A 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| Other Pre-specified | Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale | A 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-weeks follow-up assessments |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |