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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 電話番号：+2348035646382
- メール：adetolatolani@yahoo.com
研究場所
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Kaduna State
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Zaria、Kaduna State、ナイジェリア
- Ahmadu Bello University Teaching Hospital
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コンタクト：
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
- 電話番号：+2348035646382
- メール：adetolatolani@yahoo.com
-
主任研究者：
- Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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:
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Training and Supported risk assessment
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Task completion rate
時間枠：6 months
|
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
時間枠：6 months
|
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.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of risk calculator use
時間枠：6 months
|
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.
|
6 months
|
|
Change in knowledge score following training
時間枠：3 days
|
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.
|
3 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants predicted to have clinically significant prostate cancer
時間枠：6 months
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ABUCUHSR/2025/022
- 1K43TW013133-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。