- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300284
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
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
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Healthcare (Data Collection)
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New Jersey
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Consent and Follow up)
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New York
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Brooklyn, New York, United States, 11220
- MAIMONIDES MEDICAL CENTER (Data collection only)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Health Network
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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.
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Quality of Life Questionnaires
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
influencing decision making pre-visit
Time Frame: 3 years
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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.
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3 years
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influencing decision making post-visit
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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