Decision Support for Chemoprevention
Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
The purpose of this study is to find out whether electronic tools that provide information and reminders to people at high risk for breast cancer and their healthcare providers can increase the use of medications, such as tamoxifen, that may help lower the risk of developing breast cancer. The study will also look at how these tools can be successfully used as part of routine medical care.
調査の概要
詳細な説明
This randomized controlled trial will evaluate whether the web-based RealRisks decision aid, combined with standard educational materials, increases breast cancer chemoprevention uptake among women at high risk for breast cancer compared with standard educational materials alone. The intervention incorporates individualized breast cancer and cardiovascular disease risk information to support informed decision-making regarding chemoprevention. The primary endpoint is chemoprevention uptake at 12 months. Secondary outcomes include medication beliefs, breast cancer risk perceptions, informed choice, and decision conflict.
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:Research Nurse Navigator
- 電話番号:212-342-5162
- メール:cancerclinicaltrials@cumc.columbia.edu
研究連絡先のバックアップ
- 名前:Rita Kukafka, DrPH, MA
- 電話番号:212-305-1945
- メール:rk326@cumc.columbia.edu
研究場所
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New York
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New York、New York、アメリカ、10032
- 募集
- Columbia University Irving Medical Center
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コンタクト:
- Research Nurse Navigator
- メール:cancerclinicaltrials@cumc.columbia.edu
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コンタクト:
- 電話番号:212-342-5162
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)
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High-risk for breast cancer based upon any of the following criteria:
- Histologically-confirmed atypical hyperplasia or lobular carcinoma in situ
- At least a 3% breast cancer risk at 5 years or 5% risk at 10 years or 20% lifetime risk according to one of the following breast cancer risk models: Breast Cancer Surveillance Consortium risk calculator V3 (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#calculator), Gail Breast Cancer Risk Assessment Tool (https://bcrisktool.cancer.gov/calculator.html), Tyrer-Cuzick model V8 (https://ibis-risk-calculator.magview.com), or BOADICEA canrisk model (https://www.canrisk.org)
- Known carriers of germline pathogenic/likely pathogenic variant in the following breast cancer predisposition genes (ATM, BRCA2, CHEK2, or PALB2)
- Prior chest wall irradiation before age 30 years
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English- or Spanish-speaking
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Has a clinician affiliated with NYP/CUIMC
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Able to provide written, verbal or online informed consent
Exclusion Criteria:
- Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
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: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 |
|---|---|
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介入なし:Control
Standard educational materials regarding breast cancer chemoprevention. |
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実験的:Intervention
Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning. |
Behavioral/Educational Material |
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 |
|---|---|---|
|
Chemoprevention Uptake
時間枠:12 months after randomization
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The primary outcome is to compare the uptake of breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) at 12 months among women at high-risk for breast cancer assigned to standard educational materials alone or combined with the web-based decision aid, RealRisks. Assessed by EHR log and self-report |
12 months after randomization
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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 |
|---|---|---|
|
Beliefs about medication
時間枠:Baseline, 6 months, 12 months
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Beliefs in Medication Questionnaire (BMQ)adapted for use in chemoprevention decision-making. The BMQ includes the Necessity scale (10 items that assess how patients perceive their personal need for chemoprevention for reducing BC risk, maintaining their health, and preventing illness), the Concerns scale (10 items measuring concerns about potential adverse effects of chemoprevention). Participants rate the extent to which they agree with each item on a scale (scored 1- 5). The total score for each scale is computed by adding the scores for each scale item together and dividing by the number of items. |
Baseline, 6 months, 12 months
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Perceived Breast Cancer Risk
時間枠:Baseline, 6 months, and 12 months
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3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of breast cancer on a scale of 0 to 100% |
Baseline, 6 months, and 12 months
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Perceived Cardiovascular Disease Risk
時間枠:Baseline, 6-months and 12-months
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3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of cardiovascular disease on a scale of 0 to 100%. |
Baseline, 6-months and 12-months
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Accuracy of Perceived Breast Cancer Risk
時間枠:Baseline, 6 months, and 12 months
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Difference between perceived numeric risk estimate and actual 10-year risk of breast cancer risk according to the BCSC risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk |
Baseline, 6 months, and 12 months
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Accuracy of Perceived Cardiovascular Disease Risk
時間枠:Baseline, 6-month, and 12-month
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Difference between perceived numeric risk estimate and actual 10-year risk of Cardiovascular Disease Risk according to the 2013 ACA/AHA ASCVD risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk |
Baseline, 6-month, and 12-month
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Informed Choice
時間枠:Baseline, 6 months, and 12 months
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This measure combines the chemoprevention knowledge scale, an attitudes scale, and chemoprevention decision. Informed choice defined as 1) those who have an adequate knowledge score, a positive attitude towards chemoprevention, and decide to take chemoprevention; 2) those who have an adequate knowledge score, a negative attitude towards chemoprevention, and decide not to take chemoprevention. |
Baseline, 6 months, and 12 months
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Decision Conflict
時間枠:Baseline, 6 months, and 12 months
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Score on the 10-item Decision Conflict Scale assessing uncertainty and conflict related to decisions about chemoprevention uptake. Items are rated using three response categories: Yes (0), Unsure (2), and No (4). Scores are summed, divided by 10, and multiplied by 25. Final scores range from 0 to 100, with higher scores indicating greater conflict and lower scores indicating less conflict. |
Baseline, 6 months, and 12 months
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Intention or decision about chemoprevention uptake
時間枠:Baseline, 6 months, and 12 months
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Behavioral intentions to take chemoprevention measured using 'Given what you know right now, how likely do you think you are to take a breast cancer prevention drug in the next year?' (1 = 'not at all likely,' to 5 = 'extremely likely'). |
Baseline, 6 months, and 12 months
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Factors influencing intention about chemoprevention
時間枠:Baseline, 6 months, and 12 months
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Survey item to rank the main factors influencing a patient's decision about chemoprevention: 1) Personalized risk information; 2) polypharmacy for CVD or other comorbidities; 3) Provider recommendation; 4) RealRisks DA; 5) Other:____ |
Baseline, 6 months, and 12 months
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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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Perceived usefulness of RealRisks
時間枠:6 months and 12 months
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Preparation for Decision Making scale. 10-items assesses a patients perception of how useful a DA or decision support intervention is in preparing the respondent to communicate with their provider at a consultation making a health decision. |
6 months and 12 months
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Acceptability of RealRisks
時間枠:6 months and 12 months
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Ottawa 10-item Acceptability questionnaire includes questions evaluating comprehensibility, sufficiency of information, and overall suitability of the DA for decision making. |
6 months and 12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Rita Kukafka, DrPH, MA、Columbia University
研究記録日
主要日程の研究
研究開始 (実際)
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
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