An Observational Pilot Study to Test a Smartwatch-based EMA Method During Exercise With Breast Cancer Survivors

Study Overview
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Brief Summary
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The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called PHITbit.

Official Title
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Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer. Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period. Willing to wear the ActiGraph monitor during the assessment period. Willing to wear the study issued Fitbit Versa 3 smartwatch during the assessment period. Access to internet to complete REDCap survey assessments. Exclusion Criteria: Non-English speaking/not able to read English. Evidence of major contraindications for exercise per 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session. | The number of participants who use the smartwatch data collection app and respond to at least 3 EMAs during a single exercise session at least once during the 10-day data collection period out of the total number of participants enrolled at the end of the10-day data collection period. | 10 day data collection period | 
| Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale. | The System Usability Scale (SUS) is a 10-item self-report scale used to measure perceived usability of a system, method, or tool. Responses on the SUS range from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater acceptability. | End of study follow-up (post 10-day data collection period) | 
| Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview. | Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method. | End of study follow-up (post 10-day data collection period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period. | The number of participants with valid accelerometer data out of the total number of participants in the sample during the 10-day data collection period. | 10 day data collection period | 
| Rate of phone-based ecological momentary assessment (EMA) prompt completion. | The number of phone-based EMA survey prompts completed by participants during the 10-day data collection period out of the total number of phone-based EMA survey prompts delivered to participants. | 10 day data collection period | 
| Rate of electronic daily dairy completion. | The number of electronic daily dairies completed by participants during the 10-day data collection period out of the total number of electronic daily dairies delivered to participants. | 10 day data collection period |