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Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening (ProCaSS)

2019年4月17日 更新者:Dr Tun Firzara Abdul Malik、University of Malaya

The incidence of prostate cancer has been rising steadily both globally and in Malaysia. Besides an ageing population, another reason cited to explain the increase, is the corresponding increase in the prostate cancer screening rates, especially using non-invasive tests like the prostate specific antigen (PSA).

General practitioners, being front liners in medicine, play an important role in helping men make an informed decision on prostate cancer screening. In Malaysia, about 50% of GPs would routinely screen asymptomatic men and 95% of them would use PSA as a screening tool. Despite this, the evidence for screening is inconclusive, as evidenced from two major trials on screening [The European Randomised Study of Screening for Prostate Cancer (ERSPC) and Prostate, Lung, Colorectal and Ovarian Cancer Screening trial (PLCO)]. Furthermore, clinical practice guidelines globally provide conflicting recommendations on this subject, and none has been published in Malaysia to date.

Therefore, our study aims to determine the effectiveness of an online training module in helping GPs' better understand the controversies surrounding prostate cancer screening, and in so doing, improve their practice of screening. The investigators hypothesise that GPs who are randomised to receive their online module will be less inclined to screen unnecessarily for prostate cancer.

調査の概要

状態

わからない

詳細な説明

Study design: Randomised controlled trial

Setting: This trial will involve GPs in the Klang Valley, encompassing the Petaling district and Kuala Lumpur.

The healthcare system in Malaysia is divided into public and private sectors. Patients pay a standard minimal fee for public healthcare system whereas the private sector charges patients based on the services provided. The study will be conducted in private GP clinics as PSA testing is readily available compared to the public primary care setting. In public primary care clinics, PSA screening is not offered as part of a routine screening programme.

Sample size:

With 80% power and 5% (two-sided) significance, with an estimated 40% reduction in PSA screening from baseline in the intervention group and 10% in the control group, the number of participants needed for each group is 38 (total 76). Therefore, a total of 96 GPs in the Klang Valley will be recruited for this study, assuming a non-response rate of 20 GPs.

Intervention:

The intervention consists of two phases.

Phase 1 The research team will develop 3 self-administered, online surveys, with the input of family physicians and urologists. The surveys will capture basic demographic information about the participating GPs (but not any identifiable information), and also their overall knowledge and perception towards prostate cancer screening. In addition, all 3 surveys will also contain 5 clinical vignettes that will relate to prostate cancer screening. After reading the vignettes, the GPs will be asked whether or not they would recommend screening for the particular patient in the given scenario; and should they choose to screen, which screening method they would use (PSA, DRE, or both).

GPs will then be randomised to either receive an online training module (intervention) or none (control).

Phase 2:

Upon successful receipt of the GPs' response to the first survey, a second survey will be sent to all the GPs via email. The participants will once again be invited to read and respond to another set of vignettes of similar nature to those in phase 1.

GPs who have been randomised to the intervention arm will also receive a link in the second email that will enable them to download an online training module. The participants will be asked to view the training module prior to answering the second survey.

GPs in the control group will only receive the second survey and not the training module.

A third and final email will be sent to all the GPs who have successfully answered the second survey, 3 months after the date of receipt of their second survey response. This final survey will likewise, contain five clinical vignettes of similar nature to those of the two previous surveys. The responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later; as well as to the control group.

Recruitment:

The research team will recruit the GPs from an existing GP database which has been created from previous studies conducted in the Petaling District and Kuala Lumpur. A researcher and a research assistant will be responsible for identifying and recruiting eligible participants. An invitation letter, a study summary, a participant information sheet and consent form will be sent via email to each GP. Consenting participants will be remunerated for their time and effort spent in participating in the study. In the event response is poor, a research assistant may need to arrange an appointment to visit the GPs at their clinics'.

Analysis:

The McNemar test will be used to determine the phase differences in the proportion of GPs who perform screening unnecessarily and the differences between the intervention and control group. Chi square test will be used to compare the difference in proportions between the intervention and control groups. GPs' characteristics associated with unnecessary screening practice will be explored using logistic regression models using phase 1 data. Logistic regression will be used for binary outcomes and the analyses will be adjusted for baseline data. SPSS will be used to manage the data sets

研究の種類

介入

入学 (予想される)

96

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Lembah Pantai
      • Kuala Lumpur、Lembah Pantai、マレーシア、59100
        • Department of Primary Care Medicine, University of Malaya Medical Centre

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Full time general practitioners in the Klang valley (Petaling district and Kuala Lumpur)

Exclusion Criteria:

  • GPs who do not see male patients

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Training module (Intervention)
Responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later
Responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later; as well as to the control group.
介入なし:No training module (Control)

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
Evaluation of effectiveness of online training module among general practitioners in prostate cancer screening
時間枠:Through study completion, an average of 6 months
Difference in the change in proportions of appropriate prostate cancer screening from baseline by GPs between intervention (online training module) and control (no online training module) groups.
Through study completion, an average of 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Post-online training module knowledge in prostate cancer screening
時間枠:An average of 6 months
  1. Difference in the post-online training module knowledge and attitudes towards prostate cancer screening between the intervention and control groups.
  2. GPs' characteristics that are associated with prostate cancer screening
An average of 6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Tun Firzara Abdul Malik、University of Malaya

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年7月25日

一次修了 (実際)

2019年4月15日

研究の完了 (予想される)

2019年6月25日

試験登録日

最初に提出

2018年8月1日

QC基準を満たした最初の提出物

2018年8月13日

最初の投稿 (実際)

2018年8月16日

学習記録の更新

投稿された最後の更新 (実際)

2019年4月18日

QC基準を満たした最後の更新が送信されました

2019年4月17日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

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?

未定

IPD プランの説明

It is not yet known if there will be a plan to make IPD available.

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

前立腺がん検診の臨床試験

  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ

Online training moduleの臨床試験

3
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