Measuring Patient Expectations for Thyroid Surgery
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01412762
First received: August 3, 2011
Last updated: April 29, 2013
Last verified: April 2013
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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 2014 |
| Estimated Primary Completion Date: | July 2014 (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
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: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Surgery interview 11-087 |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013