Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •55 years old or older
- •Men diagnosed with low-risk prostate cancer currently on active surveillance
- •Men who identify having a primary care provider
- •Access and ability to use the Internet
排除标准
- •Men who are unable to read and/or speak English
- •Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)
- •PCP Inclusion Criteria:
- •Identified by patient on baseline survey as their PCP
- •Urologist and Clinic Staff Inclusion Criteria:
- •Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses
研究组 & 干预措施
Intervention website
干预措施: web-based tool (MAP- Management of Active surveillance in Prostate Cancer) (Behavioral)
Control MUSIC website
This is usual care and all urologists are encouraged to refer their patients to the patient educational materials on the MUSIC website (http://www.musicurology.com/patientmaterials/).
干预措施: MUSIC website (Behavioral)
结局指标
主要结局
Feasibility - Recruitment
时间窗: up to 9 months
Defined as the successful recruitment of 40 patients.
Feasibility - Uptake
时间窗: up to 6 months
Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
Acceptability - Mean Satisfaction Scores
时间窗: up to 4 months
Acceptability asks the extent to which participants consider the intervention is agreeable. Patients in the intervention arm will answer questions (on a 5-point Likert scale) regarding the use of the tool including: a) the tool provided me the necessary information about being on active surveillance; b) the tool helped me know what tests I needed and when; c) the tool helped me understand what my PCP can do for my active surveillance; d) the tool was easy to use; e) the amount of time it took to go through the website; and f) I would recommend the tool to other patients. We will ask an open-ended question on if the tool should have any other features in future versions. We will additionally collect paradata such as user actions (clicks) and time spent on each webpage. Mean score will be provided from a scale of 1-5 for each question. 5 indicating greater acceptability. The name of the web-based tool being studied is MAP- Management of Active surveillance in Prostate Cancer.
次要结局
未报告次要终点