Measuring Patient Expectations for Thyroid Surgery

October 19, 2023 updated by: Memorial Sloan Kettering Cancer Center

Measuring Patient Expectations for Thyroid Surgery: Development of a Patient-Reported Outcomes Instrument

The purpose of this study is to learn more about what patients undergoing surgery for thyroid cancer expect from their surgery. Your input may help us to better prepare and inform patients about their disease and its treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

138

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
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

Patients undergoing surgery for thyroid cancer will be recruited by the attending Head and Neck Surgeons and Research Study Assistants in the Head and Neck Clinic

Description

Inclusion Criteria:

  • Age ≥18 years
  • English speaking
  • Patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision

Exclusion Criteria:

  • Inability to speak or understand English
  • Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
  • Prior thyroid surgery
  • Prior radioactive iodine treatment, external beam radiation or chemotherapy

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
patient interviews
We aim to interview 15 patients with confirmed thyroid malignancy both pre- and postoperatively, for a total of 30 interviews. For the expansion of this study, we will accrue 25 patients with biopsy-proven thyroid cancer undergoing thyroidectomy to be educated with the CITSAV application prior to surgery.
Behavioral: patient interviews
The pre-operative interview will be within 4 weeks of planned surgery and the postoperative interview within 8 weeks of surgery completion. This initial study is designed to develop an instrument to measure patient preoperative expectations in this patient population.
Behavioral: CITSAV survey
Individual semi-structured qualitative interviews will be conducted with a total of 10 patients and 5 clinicians during this phase to identify and discuss levels of satisfaction, level of burden, potential obstacles to implementation, as well as suggestions for improving the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To establish a patient-reported outcomes tool for measuring preoperative expectations in patients undergoing surgery for thyroid cancer.
Time Frame: 2 year
This will be done by conducting qualitative semistructured interviews with 15 thyroid cancer patients (pre- and postoperatively) to identify recurring themes about their expectations regarding thyroid surgery.
2 year

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: Snehal Patel, 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

July 1, 2011

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimated)

August 9, 2011

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-087

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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