Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
2022年7月21日 更新者：Case Comprehensive Cancer Center
The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants.
It also evaluates participants' knowledge about prostate cancer screening and to improve understanding.
Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge.
This may increase confidence in participants' decisions.
Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.
調査の概要
状態
終了しました
条件
詳細な説明
PRIMARY OBJECTIVES:
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
研究の種類
介入
入学 (実際)
319
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
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Ohio
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Cleveland、Ohio、アメリカ、44106-5065
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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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
19年歳以上 (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
男
説明
Inclusion Criteria:
- Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
- Educational component: men over the age of 18
- Screening component: men over age 40
Exclusion Criteria:
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
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：ふるい分け
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Men over 40: Screening with intervention
Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
他の名前：
Undergo digital rectal exam by a licensed healthcare professional.
The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal.
This is considered standard of care for prostate cancer screening
他の名前：
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
他の名前：
Survey will be administered at the end of the program for participants to assess their experience
他の名前：
PSA levels will be drawn and run as per institutional Laboratory standards.
Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
他の名前：
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
他の名前：
|
|
実験的：Men 18-39: Educational intervention
Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.
|
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
他の名前：
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines.
Questions will be multiple choices and true/false/unsure answers
他の名前：
Survey will be administered at the end of the program for participants to assess their experience
他の名前：
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
他の名前：
|
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 |
|---|---|---|
|
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
時間枠：Up to 1 year
|
Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire.
The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.
|
Up to 1 year
|
|
Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions
時間枠：Up to 1 year
|
Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.
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Up to 1 year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of participants who choose to enter the clinical trial
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants who choose screening after educational intervention
時間枠：Up to 1 year
|
Up to 1 year
|
|
10-year expected mortality based on USCF 10-year Mortality Index for all participants
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants with family history of prostate cancer
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants referred to a primary care physician who did not previously have a primary care physician
時間枠：Up to 1 year
|
Up to 1 year
|
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Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
時間枠：Up to 1 year
|
Up to 1 year
|
|
Proportion of participants who expressed satisfied with this proposed informed consent and education model
時間枠：Up to 1 year
|
Up to 1 year
|
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。
捜査官
- 主任研究者：Samir Abraksia, MD、Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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)
2015年6月1日
一次修了 (実際)
2021年10月1日
研究の完了 (実際)
2022年7月1日
試験登録日
最初に提出
2015年4月14日
QC基準を満たした最初の提出物
2015年4月14日
最初の投稿 (見積もり)
2015年4月17日
学習記録の更新
投稿された最後の更新 (実際)
2022年7月25日
QC基準を満たした最後の更新が送信されました
2022年7月21日
最終確認日
2022年7月1日
詳しくは
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。
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