Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer

July 19, 2023 updated by: Memorial Sloan Kettering Cancer Center
This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Healthcare (Data Collection)
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow up)
    • New York
      • Brooklyn, New York, United States, 11220
        • MAIMONIDES MEDICAL CENTER (Data collection only)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted primarily in the MSK endocrinology and surgery clinics, which have a large volume of patients with LR-PTC choosing both surgery and AS. We also expect to expand this study to several clinics within the MSK Alliance Network and outside participating sites.

Description

Inclusion Criteria:

  • Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above
  • For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS
  • For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study.
  • Active patients of MSK and participating institutions

Exclusion Criteria:

  • Patients who have been diagnosed with a tumor greater than 2 cm
  • Patients with clinically suspicious lymphadenopathy in the neck
  • Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid cancer
This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes.
Behavioral: Questionnaires
Quality of Life Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
influencing decision making pre-visit
Time Frame: 3 years
Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
3 years
influencing decision making post-visit
Time Frame: 3 years
Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Benjamin Roman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2017

Primary Completion (Actual)

July 13, 2023

Study Completion (Actual)

July 13, 2023

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-382

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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