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

Taipei Medical University

Status: Unknown

Conditions: Neuroma, Acoustic

Treatments: Other: Decision aids

Study type: Interventional

Funder types: Other

Identifiers

NCT04101409

N201711048

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with acoustic neuroma.
2. Tumor diameter ≤ 3.5cm.
3. The tumor type is Schwannoma.

Exclusion criteria

1. Patients with acoustic neuroma less than 20 years old
2. Pregnant woman
3. Patients can not cooperate with Gamma Knife treatment
4. Patients with acoustic neuroma who do not have their own abilities
5. Tumor diameter > 3.5cm.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

DAs group

Experimental group

Description:

Shared decision making using decision aids

Treatment:

Other: Decision aids

Control group

No Intervention group

Description:

Standard oral explanation guided with booklets