Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
Primary Purpose
Neuroma, Acoustic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision aids
Sponsored by
About this trial
This is an interventional health services research trial for Neuroma, Acoustic focused on measuring decision aids, shared decision making
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DAs group
Control group
Arm Description
Shared decision making using decision aids
Standard oral explanation guided with booklets
Outcomes
Primary Outcome Measures
Decisional conflict
Total score of decisional conflict scale
Knowledge
Total score on knowledge scale
Secondary Outcome Measures
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.
Post-treatment depression
Total score of Hospital anxiety and depression scale (HADS)
Full Information
NCT ID
NCT04101409
First Posted
January 23, 2019
Last Updated
September 21, 2019
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04101409
Brief Title
Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
Official Title
Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Anticipated)
Primary Completion Date
February 29, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroma, Acoustic
Keywords
decision aids, shared decision making
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAs group
Arm Type
Experimental
Arm Description
Shared decision making using decision aids
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard oral explanation guided with booklets
Intervention Type
Other
Intervention Name(s)
Decision aids
Intervention Description
Shared decision making with decision aids
Primary Outcome Measure Information:
Title
Decisional conflict
Description
Total score of decisional conflict scale
Time Frame
4 weeks after discussion of treatment choice
Title
Knowledge
Description
Total score on knowledge scale
Time Frame
4 weeks after discussion of treatment choice
Secondary Outcome Measure Information:
Title
Decision regret
Description
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.
Time Frame
4 weeks after treatment
Title
Post-treatment depression
Description
Total score of Hospital anxiety and depression scale (HADS)
Time Frame
4 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Chun Lai
Phone
886-2-22490088
Ext
1367
Email
15596@s.tmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial
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