Understanding and Addressing Rejection of Personalized Cancer Risk Information
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 726
- 试验地点
- 2
- 主要终点
- Screening intentions
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 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography screening behavior. The study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making.
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 the baseline survey in which they receive their BCRAT model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.
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
- 否
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
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
All participants receive a personal breast cancer risk estimate using the Gail Model
干预措施: Presentation of personal breast cancer risk estimate (Behavioral)
结局指标
主要结局
Screening intentions
时间窗: At baseline survey
Participants are asked their plans to get a mammogram in the next 12 months. The question is answered on a 5-point will-will not Likert scale.
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.
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.
次要结局
- Risk rejection as measured by a validated believability scale(At baseline survey)
- Risk rejection as measured by risk relative to a typical woman their age.(At baseline survey)
- Participant score on Risk Comprehension(At baseline survey)
- Goldilocks Risk Skepticism(At baseline survey)
- Participant score on Subjective numeracy(At baseline survey)