Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 主要终点
- Decisional conflict
研究概览
简要总结
Patients with acoustic neuroma had several treatment options. One of standard treatment is to receive the Gamma knife stereotactic radiosurgery, other options included suboccipital craniotomy and conservative treatment. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits their needs.
The investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on acoustic neuroma patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and post-treatment depression. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acoustic neuroma.
- •Tumor diameter ≤ 3.5cm.
- •The tumor type is Schwannoma.
排除标准
- •Patients with acoustic neuroma less than 20 years old
- •Pregnant woman
- •Patients can not cooperate with Gamma Knife treatment
- •Patients with acoustic neuroma who do not have their own abilities
- •Tumor diameter > 3.5cm.
研究组 & 干预措施
DAs group
Shared decision making using decision aids
干预措施: Decision aids (Other)
Control group
Standard oral explanation guided with booklets
结局指标
主要结局
Decisional conflict
时间窗: 4 weeks after discussion of treatment choice
Total score of decisional conflict scale
Knowledge
时间窗: 4 weeks after discussion of treatment choice
Total score on knowledge scale
次要结局
- Post-treatment depression(4 weeks after treatment)
- Decision regret(4 weeks after treatment)
研究者
tsaiyichieh
Principal Investigator
Taipei Medical University Shuang Ho Hospital
