Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 10 day data collection period
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.
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.
时间窗: End of study follow-up (post 10-day data collection period)
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.
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.
时间窗: End of study follow-up (post 10-day data collection period)
Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.
次要结局
- Rate of electronic daily dairy completion.(10 day data collection period)
- Rate of phone-based ecological momentary assessment (EMA) prompt completion.(10 day data collection period)
- Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.(10 day data collection period)
研究者
Courtney J. Stevens
Assistant Professor of Psychiatry
Dartmouth-Hitchcock Medical Center