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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuroma, Acoustic

Intervention / Treatment
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* Other: Decision aids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAs group<br>Shared decision making using decision aids | Other: Decision aids<br>* Shared decision making with decision aids<br>|
| No Intervention: Control group<br>Standard oral explanation guided with booklets | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision aids, shared decision making