Shared Decision-making for Breast Cancer Screening in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Evaluation of the effectiveness of the /lamammo-etvous.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 lamammo-etvous.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 lamammo-etvous.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
- 否
入选标准
- •- General practitioners (GPs):
- •The following GPs will be included:
- •1) Practicing in one of the French départements (administrative area) covered by the study.
- •The following women will be included:
- •Invited to participate in OBCS by the National Health Insurance Agency (Caisse Nationale d'Assurance Maladie; CNAM) during the studied month: eligible for OBCS, therefore aged between 50 and 74 at the time of inclusion;
- •On the patient list of a GP who is covered by the study at the time of inclusion;
- •Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.
排除标准
- •- General practitioners (GPs) :
- •The following GPs will be excluded:
- •Those who do not have any patients invited for OBCS in the studied month;
- •Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
- •Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
- •Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
- •Those who are participating in the MyPEBS study (the only national study of OBCS at the time the present protocol was drawn up).
- •The following women will not be included:
- •Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
- •If their GP refuses to participate in the study; or,
- •women under guardianship.
- •The following women will be excluded:
- •Those who object to the study in accordance with regulatory procedures issued by the Data Protection Officer (DPO),
- •Those who do not respond within 1 month after the questionnaire has been sent.
研究组 & 干预措施
Standard organised cancer screening
Women and their GPs will continue to carry out usual screening.
Decisional aid for organised cancer screening
Women will receive a leaflet that presents the tool. The leaflet includes a link to access the tool, and encourages the person to consult their GP to initiate the shared decision-making process. GPs will receive a letter presenting the study that includes: a) information about shared decision-making and how to implement it; b) the letter that is sent to their patients, and c) a recommendation to implement shared decision-making with their patients.
干预措施: The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool. (Other)
结局指标
主要结局
Evaluation of the effectiveness of the /lamammo-etvous.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 \[extremely high decisional conflict\].
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 the presentation of the /lamammo-etvous.fr/ tool on the intention to participate in OBCS.(2 months)
- Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on the implementation of shared decision-making.(2 months)
- Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on women's knowledge of OBCS.(2 months)
- Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ DA tool on women's care pathways following an invitation to participate in OBCS.(2 months)
- Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.(2 months)
- 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)