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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
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neuroma, Acoustic focused on measuring decision aids, shared decision making

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 23, 2019
    Last Updated
    September 21, 2019
    Sponsor
    Taipei Medical University Shuang Ho Hospital
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    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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