The Effect of E-Based Technology to Provide Personalized Decision Aid on Breast Reconstruction for Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Body image
研究概览
简要总结
Using decision aids has been demonstrated to support women to make treatment decision effectively. However, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.The aims of this study were: Evaluate the effect of E-based & personalized breast reconstruction surgery decision aid on women's decision satisfaction and mental health.
详细描述
Randomized controlled trial will be used to examine the effect of E-based & personalized breast reconstruction surgery decision aid on decision satisfaction, body image, anxiety and depression. Participants will be randomly assigned into either experimental or control groups with 88 women in each group. After completing the questionnaires at baseline, participants in the experimental group will be asked to receive a E-based & personalized breast reconstruction surgery decision aid at clinic. Control group will only receive pamphlet and usual care. All participants will be followed up 1 week after consultation, and 1 month, 8 month and 12 month after surgery.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age of at least 20 years or under 20 years but married
- •females newly diagnosed with breast cancer who are candidates for mastectomy
- •ability to read and speak Taiwanese or Mandarin
排除标准
- •Women with cancer recurrence
- •poor cognitive function
- •diagnosed with psychiatric disease
结局指标
主要结局
Body image
时间窗: Pre-surgery, 1 month, 8 month, 12 month post surgery
The Body Image Scale (BIS) has ten items rated on a four-point Likert scale (0 \[not at all\] to 3 \[very much\]), with total scores ranging from 0 to 30. Higher scores indicate greater BI distress.
Decision Regret
时间窗: 1 month, 8 month, 12 month post surgery
Decision Regret Scale (DRS) accesses "distress or remorse after a surgery decision". This instrument contains 5 items. The items were summed, divided by 5, and multiplied by 25. Higher scores indicate greater decision regret.
Decision conflict
时间窗: Pre-surgery, 1 week after intervention
Decision Conflict Scale (DCS) accesses the perception of uncertainty in information, values or support for surgery options. This instrument contains 16 items and was developed by O'Connor. The items were summed, divided by 16, and multiplied by 25. Higher scores indicate greater decision conflict.
次要结局
- Anxiety(Pre-surgery, 1 month, 8 month, 12 month post surgery)
- Depression(Pre-surgery, 1 month, 8 month, 12 month post surgery)
- Involvement in the Breast Reconstruction (BR) decision-making process scale(1 week after intervention)
研究者
Su-Ying Fang
Associate Professor
National Cheng Kung University