A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Core Exercise Promotion Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer <60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods Willing to wear the ActiGraph monitor during assessment periods Access to internet to complete REDCap survey assessments Exclusion Criteria: 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) Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8) Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener) Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affect-regulated exercise prescription<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |