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Measuring Patient Expectations for Thyroid Surgery

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ClinicalTrials.gov Identifier: NCT01412762
Recruitment Status : Recruiting
First Posted : August 9, 2011
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Thyroid Cancer Behavioral: patient interviews Behavioral: CITSAV survey

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Patient Expectations for Thyroid Surgery: Development of a Patient-Reported Outcomes Instrument
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01412762     History of Changes
Other Study ID Numbers: 11-087
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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

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