跳至主要内容
临床试验/NCT05607849
NCT05607849尚未招募不适用

Shared Decision-making for Breast Cancer Screening in Primary Care

Nantes University Hospital0 个研究点目标入组 20,000 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20,000
主要终点
Evaluation of the effectiveness of the discutons-mammo.fr DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.

研究概览

简要总结

Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website Discutons-mammo.fr DEDICACES project 1.

DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Open Label

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evaluation of the effectiveness of the discutons-mammo.fr DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.

时间窗: 2 months

Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].

次要结局

  • Evaluation of the effect of presenting the discutons-mammo.fr DA tool on women's knowledge of OBCS.(2 months)
  • Evaluation of the effect of the presentation of the discutons-mammo.fr DA tool on women's care pathways following an invitation to participate in OBCS.(2 months)
  • Evaluation of the effect of presenting the discutons-mammo.fr DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.(2 months)
  • Evaluation of the effect of the presentation of the discutons-mammo.fr tool on the intention to participate in OBCS.(2 months)
  • Evaluation of the effect of presenting the discutons-mammo.fr DA tool on the implementation of shared decision-making.(2 months)

研究者

申办方类型
Other
责任方
Sponsor

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