Giving Information on the Risks and Limitations of Mammography Screening (GIRLS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 608
- 试验地点
- 2
- 主要终点
- Self-efficacy
研究概览
简要总结
To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.
详细描述
1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 47 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient on the active roster of physicians of MUSIC (McMaster University Sentinel and Information Collaboration; McMaster Family Health Team).
- •Due for a mammogram (have not had a mammogram ≥ 18 months) according to Canadian screening interval recommendations for routine screening.
排除标准
- •Previous history of invasive or non-invasive breast cancer.
- •At higher risk for breast cancer compared to the general population i.e. identified as having the BRCA1 or BRCA2 gene, immediate family member has had breast cancer.
- •Have had a mammogram within the last 18 months (< 18 months).
研究组 & 干预措施
Full information
The intervention arm will receive full information on the risks and benefits of mammography through:
- Decision aid
- YouTube video
- Group information session
干预措施: Full information (Other)
Control
Standard information leaflet for breast screening from Cancer Care Ontario
结局指标
主要结局
Self-efficacy
时间窗: 1 month
Decision Self-Efficacy Scale
次要结局
- Informed Choice (Knowledge)(1 month)
- Informed Choice (Attitude)(1 month)
- Decisional Conflict(1 month)
- Screening Participation(6 months and 12 months)
- Information Relevant to the Decision Making Process(1 month)
- Knowledge of the Benefits and Risks of Mammography(1 month)
- Anxiety(1 month)
- Informed Choice (Intention)(1 month)
- Trust in Medical System(1 month)
- Decision Regret(12 month)
- Acceptance of a Decision Aid in Primary Care(12 months)
- Perception of Health Provider Recommendation(1 month)