A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Study Details
Study Description
Brief Summary
The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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." |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Acceptability of the affect-regulated exercise prescription measured using the Treatment Acceptability and Preferences (TAP) Measure [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.
- Proportion of sample with valid accelerometer data at baseline [Baseline assessment]
The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline.
- Proportion of sample with valid accelerometer data at 2-weeks follow-up [2-weeks follow-up assessment]
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.
- Proportion of sample with valid accelerometer data at 6-weeks follow-up [6-weeks follow-up assessment]
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.
- Proportion of sample with valid accelerometer data at 12-weeks follow-up [12-weeks follow-up assessment]
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.
- Rate of ecological momentary assessment (EMA) survey prompt completion [Baseline through 12-weeks follow-up assessments]
The number 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.
- Acceptability of intervention content and study methods as measured via a semi-structured interview [12-weeks follow-up assessment]
Semi-structured interview to assess participants perceptions regarding their experience participating in the study.
Secondary Outcome Measures
- Average minutes of daily moderate-vigorous physical activity measured using the ActiGraph wGT3X-BT accelerometer at 12 weeks follow-up [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.
- Satisfaction with study participation as measured by the Participant Satisfaction Questionnaire [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.
- Study retention at 2-weeks follow-up [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.
- Study retention at 6-weeks follow-up [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.
- Study retention at 12-weeks follow-up [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.
Other Outcome Measures
- Change overtime in cancer-related fatigue measured using the PROMIS Fatigue Short Form 8a [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.
- Change overtime in health-related quality of life measured using the PROMIS Global Health Scale [Baseline and 12-weeks follow-up assessments]
A 10-item self-report measure with response options ranging from 1 to 5. 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 [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.
- Average minutes of daily moderate-vigorous physical activity measured using The Godin Leisure-Time Exercise Questionnaire at 2 weeks follow up [2-weeks follow-up assessment]
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.
- Average minutes of daily moderate-vigorous physical activity measured using The Godin Leisure-Time Exercise Questionnaire at 6 weeks follow up [6-weeks follow-up assessment]
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.
- Average minutes of daily moderate-vigorous physical activity measured using The Godin Leisure-Time Exercise Questionnaire at 12 weeks follow up [12-weeks follow-up assessment]
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.
- Average minutes of daily moderate-vigorous physical activity measured using the ActiGraph wGT3X-BT accelerometer at 2 weeks follow-up [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.
- Average minutes of daily moderate-vigorous physical activity measured using the ActiGraph wGT3X-BT accelerometer at 6 weeks follow-up [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.
- Change in voluntary exercise behavior measured using The Voluntary Exercise Questionnaire [Baseline and 12-weeks follow-up assessments]
A 3-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.
- Change in physical activity category completed in the past month measured using the Stanford Leisure-Time Activity Categorical Item (L-Cat) [Baseline and 12-weeks follow-up assessments]
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.
- Change in intentions to engage in physical activity measured using The Exercise Intentions Scale [Baseline and 12-weeks follow-up assessments]
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.
- Change in self-efficacy for exercise measured using The Barriers Specific Self-Efficacy for Exercise Scale [Baseline and 12-weeks follow-up assessments]
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.
- Change in intrinsic motivation for exercise measured using The Behavioral Regulations in Exercise Questionnaire (BREQ-2) [Baseline and 12-weeks follow-up assessments]
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.
- Change in affective attitudes about exercise using The Instrumental and Affective Attitudes about Exercise Scale [Baseline and 12-weeks follow-up assessments]
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.
- Change in instrumental attitudes about exercise using The Instrumental and Affective Attitudes about Exercise Scale [Baseline and 12-weeks follow-up assessments]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
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<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
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Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
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Willing to wear the ActiGraph monitor during assessment periods
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Access to internet to complete REDCap survey assessments
Exclusion Criteria:
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Non-English speaking/not able to read English
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Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
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Currently pregnant
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History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
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Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
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Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
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Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Health | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Courtney J Stevens, PhD, Dartmouth-Hitchcock Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY02000934_1
- K08CA259632