A Pilot Feasibility Trial Examining the Use of Electronic Patient-Reported Outcomes in Prostate Cancer Patients With Apple ResearchKit Smartphone Application
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility defined as satisfactory completion (60%) of weekly questionnaires
研究概览
简要总结
This pilot clinical trial studies how well electronic patient reported outcomes work in measuring health-related quality of life in patients with stage I-IV prostate cancer undergoing treatment. Using a smartphone application to measure and monitor symptoms before, during, and after treatment may help patients better detect, understand, and manage their health.
详细描述
PRIMARY OBJECTIVES:
I. To explore the feasibility of collecting electronic patient-reported outcome data using validated health-related quality of life (HRQOL) assessment tools at baseline, during, and after treatment through a smartphone application in adult men throughout their course of treatment for prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Self-reported ability to speak and read English
- •Be able to communicate on a touch screen iPhone
- •Willing to provide signed informed consent
- •Willing and able to comply with all study activities
- •Access to WiFi connection or cellular data
- •An established clinical history of prostate cancer in a spectrum of severity (all stages)
排除标准
- •A subject will not be eligible for inclusion in this study if in the investigator's opinion the patient has any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render them unable to complete a questionnaire)
- •Cognitive or other impairment (e.g., visual) that would interfere with completing a self- administered questionnaire and with participating in a group discussion
结局指标
主要结局
Feasibility defined as satisfactory completion (60%) of weekly questionnaires
时间窗: Up to 3 months
The rate of satisfactory completion will be estimated along with a one-sided exact 95% confidence interval. The method will be considered feasible if the lower bound of the confidence interval is above 0.7 or, equivalently, if at least 49/60 (82%) of participants have satisfactory completion. Rates of completion may be estimated by levels of baseline demographic or clinical characteristics.
次要结局
未报告次要终点