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临床试验/NCT04101409
NCT04101409Unknown不适用

Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital0 个研究点目标入组 78 人开始时间: 2019年10月15日最近更新:
适应症
干预措施

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

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

Experimental

Shared decision making using decision aids

干预措施: Decision aids (Other)

Control group

No Intervention

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

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

tsaiyichieh

Principal Investigator

Taipei Medical University Shuang Ho Hospital

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