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

Neuroma, Acoustic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04101409
• Other study ID #: N201711048
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: I-Chun Lai
• Phone: 886-2-22490088
• Email: 15596[@]s.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: May 31, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroma
• Neuroma, Acoustic

Intervention

Other:
• Decision aids
Shared decision making with decision aids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Total score of decisional conflict scale	4 weeks after discussion of treatment choice
Primary	Knowledge	Total score on knowledge scale	4 weeks after discussion of treatment choice
Secondary	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
Secondary	Post-treatment depression	Total score of Hospital anxiety and depression scale (HADS)	4 weeks after treatment