Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Ottawa Acceptability Scale
研究概览
简要总结
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
详细描述
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
- Conduct expert reviews of a prototype decision aid with clinicians
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Males aged 65 or older
- •Diagnosis of localized prostate cancer
- •On active surveillance for 12 or more months
- •Fluent in English
排除标准
- •1. Receiving treatment for another cancer (primary or recurrence)
- •Inclusion Criteria:
- •Aged 18 or older
- •Fluent in English
- •Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
- •Exclusion Criteria:
- •Inclusion Criteria:
- •Aged 18 or older
- •Fluent in English
- •Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)
- •Exclusion Criteria:
研究组 & 干预措施
Surveys
Participants may answer questions that are sensitive in nature.
干预措施: Surveys (Behavioral)
Interviews
The interview may occur over phone, web conferencing, or in-person.
干预措施: Interviews (Behavioral)
结局指标
主要结局
The Ottawa Acceptability Scale
时间窗: through study completion and average of 1 year
The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)
次要结局
未报告次要终点