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

Completed

• Conditions: Thyroid Cancer
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT03300284
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-03
• Status Verified: 2023-07
• Primary Completion: 2023-07-13
• Study Completion: 2023-07-13
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyroid cancer	Questionnaires	This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes.

Primary Outcome Measures

Name	Time	Method
influencing decision making pre-visit	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.
influencing decision making post-visit	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.

Trial Locations

Locations (5)

Memorial Sloan Kettering Monmouth (Consent and Follow up); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hartford Healthcare (Data Collection); 🇺🇸 Hartford, Connecticut, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

MAIMONIDES MEDICAL CENTER (Data collection only); 🇺🇸 Brooklyn, New York, United States