The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Informed choice
研究概览
简要总结
The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.
详细描述
The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 49 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands.
- •Women with low health literacy will be included
排除标准
- •Previous history of breast cancer
- •Difficulty speaking Spanish or Catalan
- •Cognitive impairment to understand or complete the materials based on the interviewer judgment
结局指标
主要结局
Informed choice
时间窗: Two weeks after the intervention
The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.
次要结局
- Breast screening attitudes(Two weeks after the intervention)
- Breast screening intention(Two weeks after the intervention and after being invited to be screened)
- Decisional conflict(Two weeks after the intervention)
- Confidence in the decision made(Two weeks after the intervention)
- Anxiety about screening participation(Two weeks after the intervention)
- Worry about breast cancer(Two weeks after the intervention)
- Anticipated regret(Two weeks after the intervention)
- Time perspective(Two weeks after the intervention)
- Perceived importance of benefit/harms of screening(Two weeks after the intervention)
- Perceived risk of breast cancer(Two weeks after the intervention)
研究者
Montserrat Rue
Professor
Institut de Recerca Biomèdica de Lleida