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Clinical Trials/NCT04101409
NCT04101409
Unknown
Not Applicable

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

Taipei Medical University Shuang Ho Hospital0 sites78 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuroma, Acoustic
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
78
Primary Endpoint
Decisional conflict
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
May 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Principal Investigator
Principal Investigator

tsaiyichieh

Principal Investigator

Taipei Medical University Shuang Ho Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with acoustic neuroma.
  • Tumor diameter ≤ 3.5cm.
  • The tumor type is Schwannoma.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Decisional conflict

Time Frame: 4 weeks after discussion of treatment choice

Total score of decisional conflict scale

Knowledge

Time Frame: 4 weeks after discussion of treatment choice

Total score on knowledge scale

Secondary Outcomes

  • Post-treatment depression(4 weeks after treatment)
  • Decision regret(4 weeks after treatment)

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