Thyroid NoduleNCT02878044
Shared Decision Making in Patients With Thyroid Nodules
A study testing Thyroid Decision Aid in people with Thyroid Nodule and Thyroid Cancer, run by Mayo Clinic at 2 sites in United States.
Trial summary
The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer
- What is being tested?
- Thyroid Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2016to 23 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Clinical diagnosis of low risk thyroid cancer
Who cannot join
- -Does not have the cognitive capacity to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Being tested
- Thyroid Decision Aid
- Keywords
- Shared Decision Making, Decision Aid
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid Decision AidOther
The Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Arm | Experimental | Not described Receives: Other: Thyroid Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of treatment choices between patients receiving usual care versus decision aid
Distribution of treatment choices between patients receiving usual care versus decision aid
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start18 Aug 2016
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan P. Brito Campana, MBBS, Mayo Clinic
- Investigators
- Juan P Brito Campana, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878044
- Sponsor's protocol ID
- 16-003809
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2016
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Patients With Thyroid Nodules
- ClinicalTrials.gov ID
- NCT02878044
- Acronym / sponsor ID
- 16-003809
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Keywords
- Shared Decision Making, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation Arm | Experimental | Other: Thyroid Decision Aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Clinical diagnosis of low risk thyroid cancer
Key exclusion criteria (1 listed)
- -Does not have the cognitive capacity to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid Decision AidThe Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules. | Other | Implementation Arm |
Primary outcome
Distribution of treatment choices between patients receiving usual care versus decision aid
Time frame: Up to six months
Distribution of treatment choices between patients receiving usual care versus decision aid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Brito Campana, MBBS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid Decision Aid in people with Thyroid Nodule and Thyroid Cancer, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of treatment choices between patients receiving usual care versus decision aid (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.