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
Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
Supported Risk Assessment
None
Single group
(a) Training and (b) Supported risk assessment
Other intervention1. 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.
Task completion rate
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.
Perceived feasibility of risk calculator use
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.
Acceptability of risk calculator use
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.
Change in knowledge score following training
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.
Proportion of participants predicted to have clinically significant prostate cancer
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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Ahmadu Bello University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
This trial is not recruiting at the moment. You can still explore other options: