PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria (PROACT)
Clinical Risk Calculator Validation and Implementation to Optimize Prostate Cancer Early Detection in Nigeria
This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population.
The main questions the validation study aims to answer are:
- How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?
- Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer?
The main questions the intervention study aims to answer is:
Will the primary care provider-facing risk calculator be feasible and acceptable for primary care providers to implement?
The intervention trial will be piloted among participants in community-level hospitals in order to primarily assess implementation outcomes
研究概览
地位
详细说明
The validation study will use prospective data from 500 participants with suspicion of prostate cancer to compare the effectiveness of prostate cancer risk calculator(s).
The intervention study is the only specific aim that meets the definition of a Clinical Trial. This clinicaltrial.gov information is based on the intervention study.
- For training, healthcare practitioners from community-level hospitals will be invited to participate. Before the training, a pre-test questionnaire will be given to conveniently sampled attending participants. After the training, the same questionnaire will be given to the same participants. The pre- and post-training knowledge scores will be compared to see if there is a change in knowledge.
- Supported risk assessment with the risk calculator will be piloted for at least six months. Primary care providers at community-level hospitals will use the online risk calculator to assess prostate cancer risk in patient participants 40-79 years old who are accessing their services. After the risk assessment, we will evaluate feasibility and acceptability using a mixed methods approach.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 电话号码：+2348035646382
- 邮箱：adetolatolani@yahoo.com
学习地点
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Kaduna State
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Zaria、Kaduna State、尼日利亚
- Ahmadu Bello University Teaching Hospital
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接触：
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 电话号码：+2348035646382
- 邮箱：adetolatolani@yahoo.com
-
首席研究员：
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
- Supported Risk Assessment
(i) Eligible key informants will be eligible primary care providers who were trained and implemented the supported risk assessment and the targeted population of patient participants who received the supported risk assessment.
(ii) Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.
Exclusion Criteria:
-
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Training and Supported risk assessment
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|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Task completion rate
大体时间：6 months
|
The percentage of risk calculator tasks successfully completed by providers during the risk assessment of patient participants.
A task will be be considered successfully completed if all required steps are performed.
Task completion will be documented using a standardized activity checklist and summarized using descriptive statistics.
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6 months
|
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Perceived feasibility of risk calculator use
大体时间：6 months
|
Feasibility will be assessed through participants' perceptions of the suitability of the risk calculator for its intended clinical purpose and its fit within routine clinical workflow.
Data will be collected through qualitative feedback interviews and analyzed using thematic analysis.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability of risk calculator use
大体时间：6 months
|
Acceptability will be assessed through participants' perceptions of the content relevance and perceived complexity of the risk calculator for clinical decision-making.
Data will be collected through qualitative feedback interviews and analyzed using thematic analysis.
|
6 months
|
|
Change in knowledge score following training
大体时间：3 days
|
Knowledge will be assessed using a structured questionnaire administered before and after training.
Each questionnaire item will be scored as 1 for a correct response and 0 for an incorrect response.
The total knowledge score will be calculated as the sum of correct responses.
The change in knowledge score from pre-training to post-training assessment will be analyzed using inferential statistics.
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3 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants predicted to have clinically significant prostate cancer
大体时间：6 months
|
The proportion of participants classified by the risk calculator as having a predicted risk of clinically significant prostate cancer.
The outcome will be reported as the number and percentage of participants predicted to have clinically significant prostate cancer among all assessed participants.
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6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ABUCUHSR/2025/022
- 1K43TW013133-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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