Bridging the Digital Divide of Wearables to Improve Health Outcomes and Quality of Life Among Black Prostate Cancer (CaP) Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adherence rate
研究概览
简要总结
This clinical trial studies how well the InBody Band 3 fitness tracker works to improve physical activity, body composition, and quality of life in Black prostate cancer survivors. Prostate cancer is the most common cancer in men and Black men are more likely to be diagnosed with prostate cancer in an advanced stage. Body composition is associated with disease progression, treatment response, and survival in cancer patients. Reducing stress and maintaining healthy levels of physical activity and sleep are important for a healthy body and improving outcomes, however, there is currently little evidence available on the physical activity, stress levels and sleep patterns in this population. Wearable health activity trackers and smart watches are tools that can be used to track physical activity, stress, sleep and body composition and have been shown to have a positive impact in many patient populations. The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility of a remote wearables-based intervention among Black prostate cancer survivors.
II. Assess the acceptability of the wearables-based intervention among Black prostate cancer survivors.
OUTLINE:
Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to read/speak English and are able to communicate by phone
- •18 years of age or older
- •Self-identify as Black
- •Have been diagnosed with stage I-IV prostate cancer
- •Have an active email address and are able to regularly check emails for electronic surveys
- •Own and are willing to use a personal smartphone with regular/reliable access to the internet to sync regularly with a fitness tracker
- •Are willing to wear and use a smart fitness tracker for 6 weeks and allow sharing of their fitness data with the study team
- •Are not currently undergoing adjunct cancer therapy (e.g. chemotherapy, radiation) during the 6 weeks of study participation, except oral tyrosine kinase inhibitor or hormonal therapies; and
- •Are an existing Mayo patient
- •Self-report that they would like to improve their physical activity during initial study coordinator contact
排除标准
- •Live outside of the United States (U.S)
- •Have an implanted medical device (e.g., pacemaker, etc.) or a life-sustaining device (e.g., patient monitoring device)
- •Have a self-reported history of a psychiatric disorder(s) or moderate to severe cognitive impairment precluding participation in the study intervention or preventing the ability to provide independent informed consent
- •Are on prolonged bed rest (i.e., more than half of the waking day in bed) by self-report
- •Currently have any lower extremity injury that impedes them from engaging in walking for one block
- •Are unable to walk for at least one block without a walking aide by self-report; or
- •Regularly use a wheelchair for mobility by self-report
研究组 & 干预措施
Supportive care (InBody Band 3 fitness tracker)
Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.
干预措施: Discussion (Other)
Supportive care (InBody Band 3 fitness tracker)
Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.
干预措施: Medical Device Usage and Evaluation (Other)
Supportive care (InBody Band 3 fitness tracker)
Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Adherence rate
时间窗: Up to 6 weeks
The adherence rate will be calculated as the ratio of number of valid data collection weeks to the number of expected valid data collection weeks for each participant. A group average adherence rate of 80% will be considered feasible.
Change in acceptability scale score
时间窗: Up to 8 weeks
Will be assessed using the 6-item Acceptability survey for physical activity interventions. Participants will be asked to rate each question from 0 (not at all) to 10 (extremely), and a mean score will be calculated. An average group rating of 8.0 or higher on a 10-point scale will be required to determine intervention acceptability. Change in score will be defined as the final intervention week's value minus the first week's value.
次要结局
未报告次要终点
研究者
Emma Fortune Ngufor
Principal Investigator
Mayo Clinic