Back to resultsShared Decision Making in Patients With Thyroid Nodules
Primary Purpose
Thyroid Nodule, Thyroid Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thyroid Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Thyroid Nodule focused on measuring Shared Decision Making, Decision Aid
Eligibility Criteria
Inclusion Criteria:
-Clinical diagnosis of low risk thyroid cancer
Exclusion Criteria:
-Does not have the cognitive capacity to provide consent
Sites / Locations
- Mayo Clinic Jacksonville
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implementation Arm
Arm Description
Outcomes
Primary Outcome Measures
Distribution of treatment choices between patients receiving usual care versus decision aid
Distribution of treatment choices between patients receiving usual care versus decision aid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02878044
Brief Title
Shared Decision Making in Patients With Thyroid Nodules
Official Title
Shared Decision Making in Patients With Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2016 (Actual)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Thyroid Cancer
Keywords
Shared Decision Making, Decision Aid
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implementation Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Thyroid Decision Aid
Intervention Description
The Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules.
Primary Outcome Measure Information:
Title
Distribution of treatment choices between patients receiving usual care versus decision aid
Description
Distribution of treatment choices between patients receiving usual care versus decision aid
Time Frame
Up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Clinical diagnosis of low risk thyroid cancer
Exclusion Criteria:
-Does not have the cognitive capacity to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Brito Campana, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Shared Decision Making in Patients With Thyroid Nodules
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