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

NCT03300284 | Completed

• 1 other identifier: 17-382
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Thyroid Cancer

Keywords

Quality of Life; Decision Making; 17-382

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

Questionnaires BEHAVIORAL

Quality of Life Questionnaires

Thyroid cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Hartford Healthcare (Data Collection)

Hartford, Connecticut, 06102, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Follow up)

Middletown, New Jersey, 07748, United States

Location

MAIMONIDES MEDICAL CENTER (Data collection only)

Brooklyn, New York, 11220, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Benjamin Roman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: August 7, 2017
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (5)