Back to resultsAIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Primary Purpose
Thyroid Nodules, Thyroid Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling using the electronic conversation aid
counseling by routine care
Sponsored by
About this trial
This is an interventional other trial for Thyroid Nodules focused on measuring thyroid nodules, shared decision making
Eligibility Criteria
Inclusion Criteria:
- Adults >18 years old presenting for evaluation of a thyroid nodule
Exclusion Criteria:
- Patients with hyperthyroidism
- Patients with previous biopsy of the nodule of interest
- Pregnant patients
- Prisoners
Sites / Locations
- University of FloridaRecruiting
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control Group
Arm Description
Counseling using the electronic conversation aid
Routine counseling only
Outcomes
Primary Outcome Measures
Proportion of eligible patients for feasibility
Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).
Secondary Outcome Measures
Full Information
NCT ID
NCT04463719
First Posted
July 6, 2020
Last Updated
July 18, 2023
Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04463719
Brief Title
AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Official Title
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules, Thyroid Cancer
Keywords
thyroid nodules, shared decision making
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Counseling using the electronic conversation aid
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Routine counseling only
Intervention Type
Behavioral
Intervention Name(s)
Counseling using the electronic conversation aid
Intervention Description
Patients receive counseling about thyroid biopsy with the use of the conversation aid.
Intervention Type
Behavioral
Intervention Name(s)
counseling by routine care
Intervention Description
Patients receive counseling by routine care without the use of the conversation aid
Primary Outcome Measure Information:
Title
Proportion of eligible patients for feasibility
Description
Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).
Time Frame
at 6 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >18 years old presenting for evaluation of a thyroid nodule
Exclusion Criteria:
Patients with hyperthyroidism
Patients with previous biopsy of the nodule of interest
Pregnant patients
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina, MD
Phone
352-273-8656
Email
Naykky.SinghOspina@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Behnken
Email
Behnken.Emma@mayo.edu
First Name & Middle Initial & Last Name & Degree
Victor Montori
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
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