Living Well After Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of patients enrolled per month
研究概览
简要总结
Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.
详细描述
Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer.
Participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. Tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. Participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper.
The baseline survey and second survey will each take approximately 45 minutes for participants to complete. The third survey will take approximately 30 minutes for participants to complete.
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
- Single (Participant)
盲法说明
Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (18 years or older)
- •New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS)
- •Not yet had mastectomy
- •Considering or planning to have mastectomy
- •Able to read and speak English
- •Competent to make health care decisions
排除标准
- •Age less than 18 years
- •Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma
- •Already had mastectomy for this diagnosis
- •Planning to have breast conservation therapy
- •Not being treated by a Texas Oncology surgeon or oncologist
- •Not able to read and speak English
- •Not competent to make health care decisions
结局指标
主要结局
Number of patients enrolled per month
时间窗: 12 months
To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month.
Proportion of patients retained at 6 months
时间窗: 6 months
To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment.
次要结局
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.(6 months)
- How a patient decision aid about breast reconstruction affects knowledge about reconstruction.(6 months)
- How a patient decision aid about breast reconstruction affects decision making outcomes.(6 months)
研究者
Michael P Pignone
Professor of Medicine
University of Texas at Austin