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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
89
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.
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna State, Nigeria
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
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