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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300284
• Other study ID #: 17-382
• Status: Completed
• Start date: August 7, 2017
• Est. completion date: July 13, 2023

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Behavioral:
• Questionnaires
Quality of Life Questionnaires

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	MAIMONIDES MEDICAL CENTER (Data collection only)	Brooklyn	New York
United States	Hartford Healthcare (Data Collection)	Hartford	Connecticut
United States	Memorial Sloan Kettering Monmouth (Consent and Follow up)	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	influencing decision making pre-visit	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
Primary	influencing decision making post-visit	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

External Links

•   Memorial Sloan Kettering Cancer Center