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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04101409
Enrollment
78
Registered
2019-09-24
Start date
2019-10-15
Completion date
2020-05-31
Last updated
2019-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroma, Acoustic

Keywords

decision aids, shared decision making

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.

Interventions

Shared decision making with decision aids

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflict4 weeks after discussion of treatment choiceTotal score of decisional conflict scale
Knowledge4 weeks after discussion of treatment choiceTotal score on knowledge scale

Secondary

MeasureTime frameDescription
Decision regret4 weeks after treatmentTotal 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.
Post-treatment depression4 weeks after treatmentTotal score of Hospital anxiety and depression scale (HADS)

Contacts

Primary ContactI-Chun Lai
15596@s.tmu.edu.tw886-2-22490088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026