An interventional study of (a) Training and (b) Supported risk assessment in Prostate Cancer, Risk Assessment and Clinical Decision Support Systems, sponsored by Ahmadu Bello University. Not yet recruiting at 1 site in Nigeria. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Ahmadu Bello University · Not applicable, Interventional, and Prevention
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:
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
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.
(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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Other: (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.
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 3 days
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.
Time frame: 6 months
Plan to share: Yes — The scientific data and metadata will be assigned a digital object identifier number. This citable link will be referenced in associated publications and discoverable during repository search.
Supporting information: Csr, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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