NCT02878044

Brief Summary

The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

August 16, 2016

Last Update Submit

January 5, 2022

Conditions

Thyroid NoduleThyroid Cancer

Keywords

Shared Decision Making, Decision Aid

Outcome Measures

Primary Outcomes (1)

  • Distribution of treatment choices between patients receiving usual care versus decision aid

    Distribution of treatment choices between patients receiving usual care versus decision aid

    Up to six months

Study Arms (1)

Implementation Arm

EXPERIMENTAL
Other: Thyroid Decision Aid

Interventions

Thyroid Decision AidOTHER

The Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules.

Implementation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of low risk thyroid cancer

You may not qualify if:

  • Does not have the cognitive capacity to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Thyroid NoduleThyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Juan P Brito Campana, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Senior Associate Consultant

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 25, 2016

Study Start

August 18, 2016

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)