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

Not Applicable

• Conditions: Neuroma, Acoustic
• Interventions: Other: Decision aids

• Registration Number: NCT04101409
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-21
• Last Update Submitted: 2019-09-21
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Study Start: 2019-10-15
• Primary Completion: 2020-02-29
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAs group	Decision aids	Shared decision making using decision aids

Primary Outcome Measures

Name	Time	Method
Decisional conflict	4 weeks after discussion of treatment choice	Total score of decisional conflict scale
Knowledge	4 weeks after discussion of treatment choice	Total score on knowledge scale

Secondary Outcome Measures

Name	Time	Method
Post-treatment depression	4 weeks after treatment	Total score of Hospital anxiety and depression scale (HADS)
Decision regret	4 weeks after treatment	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.