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

NCT04101409 | Unknown

• 1 other identifier: N201711048
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroma, Acoustic

Keywords

decision aids; shared decision making

Outcome Measures

Primary Outcomes (2)

• Decisional conflict

  Total score of decisional conflict scale

  4 weeks after discussion of treatment choice

• Knowledge

  Total score on knowledge scale

  4 weeks after discussion of treatment choice

Secondary Outcomes (2)

• Decision regret

  4 weeks after treatment

• Post-treatment depression

  4 weeks after treatment

Study Arms (2)

DAs group

EXPERIMENTAL

Shared decision making using decision aids

Other: Decision aids

Control group

NO INTERVENTION

Standard oral explanation guided with booklets

Interventions

Decision aids OTHER

Shared decision making with decision aids

DAs group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

I-Chun Lai

CONTACT

886-2-22490088; 15596@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: September 24, 2019
• Study Start: October 15, 2019
• Primary Completion: February 29, 2020
• Study Completion: May 31, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09