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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 전화번호: +2348035646382
- 이메일: adetolatolani@yahoo.com
연구 장소
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Kaduna State
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Zaria, Kaduna State, 나이지리아
- Ahmadu Bello University Teaching Hospital
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연락하다:
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 전화번호: +2348035646382
- 이메일: adetolatolani@yahoo.com
-
수석 연구원:
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Training and Supported risk assessment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Task completion rate
기간: 6 months
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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
기간: 6 months
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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.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability of risk calculator use
기간: 6 months
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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.
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6 months
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Change in knowledge score following training
기간: 3 days
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants predicted to have clinically significant prostate cancer
기간: 6 months
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ABUCUHSR/2025/022
- 1K43TW013133-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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