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Decision Support for Chemoprevention

2026年11月4日 更新者:Rita Kukafka、Columbia University

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

状態

募集

条件

介入・治療

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

介入

入学 (推定)

240

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • New York
      • New York、New York、アメリカ、10032
        • 募集
        • Columbia University Irving Medical Center
        • コンタクト:
        • コンタクト:
          • 電話番号:212-342-5162

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

40年~79年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  1. Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)

  2. 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
  3. English- or Spanish-speaking

  4. Has a clinician affiliated with NYP/CUIMC

  5. 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

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: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
介入なし:Control

Standard educational materials regarding breast cancer chemoprevention.

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

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

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

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
Perceived Breast Cancer Risk
時間枠:Baseline, 6 months, and 12 months

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
Perceived Cardiovascular Disease Risk
時間枠:Baseline, 6-months and 12-months

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
Accuracy of Perceived Breast Cancer Risk
時間枠:Baseline, 6 months, and 12 months

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
Accuracy of Perceived Cardiovascular Disease Risk
時間枠:Baseline, 6-month, and 12-month

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
Informed Choice
時間枠:Baseline, 6 months, and 12 months

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
Decision Conflict
時間枠:Baseline, 6 months, and 12 months

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
Intention or decision about chemoprevention uptake
時間枠:Baseline, 6 months, and 12 months

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
Factors influencing intention about chemoprevention
時間枠:Baseline, 6 months, and 12 months

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

その他の成果指標

結果測定
メジャーの説明
時間枠
Perceived usefulness of RealRisks
時間枠:6 months and 12 months

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
Acceptability of RealRisks
時間枠:6 months and 12 months

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

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

協力者

捜査官

  • 主任研究者:Rita Kukafka, DrPH, MA、Columbia University

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)

2026年10月7日

一次修了 (推定)

2028年9月1日

研究の完了 (推定)

2028年9月1日

試験登録日

最初に提出

2026年10月1日

QC基準を満たした最初の提出物

2026年10月23日

最初の投稿 (実際)

2026年10月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11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

  • AAAV2148
  • 5R01CA293927-03 (米国 NIH グラント/契約)

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

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