Communicating Objective Risk for Personalized Decision Making About Mammography
2017年7月20日 更新者：University of Pennsylvania
The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial.
Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths.
Two presentation formats will be tested and compared.
調査の概要
詳細な説明
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
研究の種類
介入
入学 (実際)
1560
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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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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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
35年～49年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Exclusion Criteria:
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
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：階乗代入
- 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 |
|---|---|
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介入なし：Control group 1: pre/post-test
Group receives pre and post test questions only.
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実験的：Control group 2: tool and pre/post-test
Group receives decision tool without personalized information.
(Behavioral: Decision Aid)
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実験的：Gail score in a percentage format
Group receives Gail score in a percentage format.
(Behavioral: Decision Aid)
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実験的：Gail score in a frequency format
Group receives Gail score in a frequency format.
(Behavioral: Decision Aid)
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実験的：Frequency + Average 50 year old
Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman.
(Behavioral: Decision Aid)
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実験的：Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography.
(Behavioral: Decision Aid)
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実験的：Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography.
(Behavioral:Decision Aid)
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実験的：Frequency + Avg 50 year old + Mamm Data + Mortality Data
Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography.
(Behavioral: Decision Aid)
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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 |
|---|---|---|
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Behavioral intentions to get a mammogram
時間枠：immediately following intervention (time 0)
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All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
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immediately following intervention (time 0)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Attitude about mammography
時間枠：immediately following intervention (time 0)
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Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
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immediately following intervention (time 0)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Injunctive and descriptive norms about mammography
時間枠：immediately following intervention (time 0)
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Participants will be asked to report their perceived norms about mammography, what they think important others would expect them to do and what they think other women their age or older are doing.
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immediately following intervention (time 0)
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Decisional satisfaction
時間枠：immediately following intervention (time 0)
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This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided.
Items include, "The information in the decision aid made me feel the choice to get a mammogram is being taken away from me by the groups that make screening recommendations."
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immediately following intervention (time 0)
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Risk perception
時間枠：immediately before and after intervention (time 0)
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This variable includes perceived severity and perceived susceptibility of breast cancer.
Items include, "What is the chance that an average 40-49 year old woman will develop breast cancer in the next 10 years?
Please choose a number between 0 (no chance of breast cancer) and 100 (definitely will get breast cancer)."
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immediately before and after intervention (time 0)
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Clarity of the information being presented
時間枠：immediately following intervention (time 0)
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These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
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immediately following intervention (time 0)
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Credibility of the information
時間枠：immediately following intervention (time 0)
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These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid.
Items include, "How credible did you find the information presented in the decision aid?"
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immediately following intervention (time 0)
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Emotional reactions
時間枠：immediately following intervention (time 0)
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The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid.
Items include, "How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?"
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immediately following intervention (time 0)
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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：Joseph N Cappella, PhD、University of Pennsylvania
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
2012年9月1日
一次修了 (実際)
2012年12月18日
研究の完了 (実際)
2012年12月18日
試験登録日
最初に提出
2012年8月28日
QC基準を満たした最初の提出物
2012年9月17日
最初の投稿 (見積もり)
2012年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月21日
QC基準を満たした最後の更新が送信されました
2017年7月20日
最終確認日
2017年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 816186
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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