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

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.

Study Overview

• Status: Unknown
• Conditions: Neuroma, Acoustic
• Intervention / Treatment: Other: Decision aids

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I-Chun Lai; Phone Number: 1367 886-2-22490088; Email: 15596@s.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAs group; Shared decision making using decision aids	Other: Decision aids; Shared decision making with decision aids
No Intervention: Control group; Standard oral explanation guided with booklets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision regret	Total score of decision regret, The dependent variable for this study was decision regret, assessed using the Decision Regret Scale (DRS). The DRS consists of five statements: (1) It was the right decision; (2) I regret the choice that was made; (3) I would go for the same choice if I had to do it over again; (4) the choice did me a lot of harm, and (5) the decision was a wise one. Agreement with each statement is measured on a five-point Likert scale (1 = strongly agree to 5 = strongly disagree). Score of each item is converted to a 0-100 scale by subtracting 1 from each item and multiplying by 25. Scores from items 2 and 4 are reversed. To obtain a global score, all items are summed and the total is divided by 5. Scores range from 0 (no regret) to 100 (high regret), increasing by increments of 5. Ref. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D Med Decis Making. 2003 Jul-Aug; 23(4):281-92.	4 weeks after treatment
Post-treatment depression	Total score of Hospital anxiety and depression scale (HADS)	4 weeks after treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2019
• Primary Completion (Anticipated): February 29, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 21, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: shared decision making; decision aids
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neurilemmoma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuroma; Neuroma, Acoustic
• Other Study ID Numbers: N201711048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No