Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Delivery Rate
研究概览
简要总结
This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.
详细描述
PRIMARY OBJECTIVES:
I. To design a patient decision aid video about breast reconstruction. II. To pilot test its acceptability with women. III. To field test the feasibility of delivery pre-consultation and efficacy at preparing women for their discussion with their plastic surgeon.
OUTLINE:
FOCUS GROUP: Survivors who previously considered breast reconstruction participate in a 40 to 60-minute focus group to gather feedback on currently-available patient decision aids and educational materials. The research team uses their feedback to create an initial prototype of a patient decision aid video
PILOT TEST: Survivors who previously considered breast reconstruction review the initial prototype of the patient decision aid video, then complete a questionnaire providing their feedback about the video's strengths and areas that could be improved. The research team then incorporates their feedback into the video."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aims 1 and 2: Patients who are 6 months to 3 years post-mastectomy surgery
- •Aim 3: Patients who are scheduled for their first breast reconstruction consultation with plastic surgery
- •Able to speak, read, and write English
排除标准
- •Women with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in their medical record)
- •Women for whom the video and workbook would not be appropriate due to clinical characteristics or contraindications (as determined by a provider)
结局指标
主要结局
Delivery Rate
时间窗: Up to 3 months prior to plastic surgery consultation
The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after the consultation.
次要结局
- Type of surgery completed(Up to 1 year after surgery)
- Breast Reconstruction Knowledge Questionnaire(Up to 3 months prior to plastic surgery consultation)
- Preparation for Decision Making Scale(Immediately after intervention)
- BREAST-Questionnaire (Q)(Up to 1 year prior to surgery, up to 1 year after surgery)
- Decisional Conflict Scale(Immediately before intervention, immediately after intervention, immediately after consultation)