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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
研究概览
简要总结
The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 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
排除标准
- •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
结局指标
主要结局
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
时间窗: 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.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up
时间窗: 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, multiplied by 100%.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion
时间窗: Baseline through 12-weeks follow-up assessments
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.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up
时间窗: 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, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up
时间窗: 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, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at Baseline
时间窗: Baseline assessment
The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Number of Participants Who Completed the Exit Interview
时间窗: 12-weeks follow-up assessment
Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.
次要结局
- Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire(12-weeks follow-up assessment)
- Study Retention at 12-weeks Follow-up(12-weeks follow-up assessment)
- 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)
- Study Retention at 2-weeks Follow-up(2-weeks follow-up assessment)
- Study Retention at 6-weeks Follow-up(6-weeks follow-up assessment)
研究者
Courtney J. Stevens
Assistant Professor of Psychiatry
Dartmouth-Hitchcock Medical Center