NCT01412762

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2011Jul 2026

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

15 years

First QC Date

August 3, 2011

Last Update Submit

August 1, 2025

Conditions

Keywords

Surgeryinterview11-087

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 interviewsBehavioral: CITSAV survey

Interventions

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.

patient interviews
CITSAV surveyBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age ≥18 years
  • English speaking
  • Patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Snehal Patel, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 9, 2011

Study Start

July 1, 2011

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 3, 2025

Record last verified: 2025-08

Locations