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Measuring Patient Expectations for Thyroid Surgery

This study is currently recruiting participants.
Verified November 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412762
First Posted: August 9, 2011
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
August 3, 2011
August 9, 2011
November 9, 2017
July 2011
July 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01412762 on ClinicalTrials.gov Archive Site
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Measuring Patient Expectations for Thyroid Surgery
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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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
Thyroid Cancer
  • 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
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.
Interventions:
  • Behavioral: patient interviews
  • Behavioral: CITSAV survey
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Snehal Patel, MD 212-639-3412
Contact: Andrea Pusic, MD 212-639-5085
United States
 
 
NCT01412762
11-087
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Snehal Patel, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
November 2017