PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria

Официальное название

Clinical Risk Calculator Validation and Implementation to Optimize Prostate Cancer Early Detection in Nigeria

Обзор

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: 1. How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer? 2. 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

Подробное описание

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.

1. 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. 2. 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.

Вмешательства

• Другое (a) Training and (b) Supported risk assessment
  1. The training intervention will be facilitated by experienced clinical mentors through didactics and demonstrations and conducted as half-day sessions over 3 days 2. This intervention includes risk calculator use and clinical mentorship for at least six months.

Первичные конечные точки

• Task completion rate [Срок оценки: 6 months]
• Perceived feasibility of risk calculator use [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Acceptability of risk calculator use [Срок оценки: 6 months]
• Change in knowledge score following training [Срок оценки: 3 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Nigeria · 1 центр

• Ahmadu Bello University Teaching Hospital — Zaria

Идентификаторы

NCT: NCT07733440 · ABUCUHSR/2025/022 · 1K43TW013133-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗