Measuring Patient Expectations for Thyroid Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01412762
First received: August 3, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Thyroid Cancer
Behavioral: patient interviews

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Patient Expectations for Thyroid Surgery: Development of a Patient-Reported Outcomes Instrument

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To establish a patient-reported outcomes tool for measuring preoperative expectations in patients undergoing surgery for thyroid cancer. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patient interviews
We aim to interview 15 patients with confirmed thyroid malignancy both pre- and postoperatively, for a total of 30 interviews.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412762

Contacts
Contact: Snehal Patel, MD 212-639-3412
Contact: Andrea Pusic, MD 212-639-5085

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Snehal Patel, MD    212-639-3412      
Contact: Andrea Pusic, MD    212-639-5085      
Principal Investigator: Adrea Pusic, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Snehal Patel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01412762     History of Changes
Other Study ID Numbers: 11-087
Study First Received: August 3, 2011
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Surgery
interview
11-087

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 20, 2014