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临床试验/NCT03775213
NCT03775213已完成不适用

The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk

Duke University2 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2021年10月12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
322
试验地点
2
主要终点
Number of Participants Who Chose Active Monitoring (AM).

研究概览

简要总结

The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).

详细描述

Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM) as an alternative to immediate surgery for select patient groups. Little is known about women's acceptability of AM after a diagnosis with DCIS.

Here the study team seeks to answer the question: if AM is found to be a safe alternative to immediate surgery, how likely are women to choose it as their first course of treatment?

In this study, women are asked to imagine having recently been diagnosed with DCIS. For some in the intervention arm, in-depth information about surgical options and AM are presented with a web-based decision support tool. After exploring the decision support tool, participants are asked to make a hypothetical treatment choice and to answer a series of additional questions about their decision-making process and personal preferences. Women in the control arm receive a reduced version of the decision support tool that only provides in-depth information about the surgical options (AM is mentioned as an experimental approach).

The overarching hypothesis of this study is that patients who are offered AM as a guideline-concordant care option (a potential future scenario if ongoing trials confirm the safety of AM) are more likely to choose it compared to women in current clinical practice (who receive information about surgical options only).

Primary research question: Compared to presenting active monitoring (AM) as an experimental option, does presenting AM as a guideline-concordant care option increase its uptake as treatment choice?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Sex: Female
  • Age: 50-79 years
  • Has had a negative mammographic screen in the past 12 months

排除标准

  • Personal history of breast cancer

结局指标

主要结局

Number of Participants Who Chose Active Monitoring (AM).

时间窗: Up to 1 hour

Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

次要结局

  • Number of Participants Who Perceived Active Monitoring as Risky.(Up to 1 hour)
  • Number of Participants Who Chose Mastectomy.(Up to 1 hour)
  • Change in Self-perceived Knowledge About DCIS.(Baseline and 1 hour)
  • Number of Participants Who Found the Treatment Option Acceptable.(Up to 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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