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.
研究概览
地位
地位
干预/治疗
干预/治疗
详细说明
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.
研究类型
研究类型
注册 (估计的)
注册
阶段
阶段
- 不适用
联系人和位置
学习联系方式
学习联系方式
- 姓名:Research Nurse Navigator
- 电话号码:212-342-5162
- 邮箱:cancerclinicaltrials@cumc.columbia.edu
研究联系人备份
- 姓名:Rita Kukafka, DrPH, MA
- 电话号码:212-305-1945
- 邮箱:rk326@cumc.columbia.edu
学习地点
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New York
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New York、New York、美国、10032
- 招聘中
- Columbia University Irving Medical Center
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接触:
- Research Nurse Navigator
- 邮箱:cancerclinicaltrials@cumc.columbia.edu
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接触:
- 电话号码:212-342-5162
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-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
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无干预:Control
Standard educational materials regarding breast cancer chemoprevention. |
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实验性的: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 |
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Chemoprevention Uptake
大体时间: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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次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Beliefs about medication
大体时间: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
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Perceived Breast Cancer Risk
大体时间: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
|
|
Perceived Cardiovascular Disease Risk
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
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Decision Conflict
大体时间: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
大体时间: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
大体时间: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
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Perceived usefulness of RealRisks
大体时间: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
大体时间: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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合作者和调查者
调查人员
调查人员
- 首席研究员:Rita Kukafka, DrPH, MA、Columbia University
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (估计的)
初级完成
研究完成 (估计的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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