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临床试验/NCT06975085
NCT06975085已完成不适用

Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 781 人开始时间: 2025年4月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
781
试验地点
1
主要终点
Risk rejection as measured by a numeric estimate

研究概览

简要总结

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

详细描述

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by testing hypotheses about why women reject their risk estimate and the influence of rejection on screening intentions.

The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. Participants will be required to complete a survey in which they receive their BCRAT model risk estimate and respond to that risk estimate.

研究设计

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

入排标准

年龄范围
39 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
  • English literacy
  • Black or African American race

排除标准

  • 1. Prior diagnosis of
  • breast cancer
  • Ductal carcinoma in situ (DCIS)
  • Lobular carcinoma in situ (LCIS)
  • Known BRCA1/2 gene mutation
  • Cowan syndrome
  • Li-Fraumeni syndrome
  • Having received previous chest radiation for treatment of Hodgkin's lymphoma.

研究组 & 干预措施

Breast cancer risk presentation

Other

All participants are presented with their personal breast cancer risk, estimated using the Gail Model

干预措施: Presentation of a personal breast cancer risk estimate (Behavioral)

结局指标

主要结局

Risk rejection as measured by a numeric estimate

时间窗: at baseline survey

Participants are asked whether they agree or disagree with their Gail Model risk estimate. An open text box allows them to write the risk number that they believe is accurate for them.

Risk-concordant information seeking

时间窗: at baseline survey

Participants will be given the opportunity to get more information about breast cancer screening, and will be given response options to receive information for women at lower than average risk, higher than average risk, or women with risk that is "about the same as a typical woman". Concordance is measured by agreement between the participants' actual risk estimate and the option that they choose.

Screening intentions

时间窗: at baseline survey

Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will

Number of Participants Who Rejected the Cancer Risk Estimate

时间窗: at baseline survey

Participants are asked whether they agree or disagree with their Gail Model risk estimate. Risk rejection was defined as disagreement the estimate. An open text box allows them to write the risk number that they believe is accurate for them.

Risk-concordant Information Seeking

时间窗: at baseline survey

Participants will be given the opportunity to get more information about breast cancer screening, and will be given response options to receive information for women at lower than average risk, higher than average risk, or women with risk that is "about the same as a typical woman". Concordance is measured by agreement between the participants' actual risk estimate and the option that they choose.

Screening Intentions

时间窗: at baseline survey

Screening intentions were measured on a 5-point Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will. Higher scores indicate greater intention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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