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临床试验/NCT02954900
NCT02954900已完成不适用

Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot

Columbia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in the accuracy of risk perception (Likert Scale Score)

研究概览

简要总结

The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.

详细描述

Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).

The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
  • The participant understands and is willing to provide informed consent in English or Spanish
  • Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital

排除标准

  • Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
  • Prior history of breast cancer

结局指标

主要结局

Change in the accuracy of risk perception (Likert Scale Score)

时间窗: Baseline, 2 weeks

To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.

次要结局

  • Chemoprevention uptake rate among high-risk women(6 months)
  • Referral rates to the breast clinic(12 months)
  • Change in a patient's breast cancer knowledge (Survey Score)(Baseline, 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine D. Crew

Associate Professor of Medicine and Epidemiology

Columbia University

研究点 (1)

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