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NCT01412762 Clinical Trial

Measuring Patient Expectations for Thyroid Surgery

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01412762
Other study ID # 11-087
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2011
Est. completion date July 2024

Study information
Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 138
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
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 To establish a patient-reported outcomes tool for measuring preoperative expectations in patients undergoing surgery for thyroid cancer. 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
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