Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Completed · Not applicable
Conditions studied: Thyroid Cancer
In brief
The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.
Key facts
- Study ID
- NCT06073223
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 50
- Starts
- 2023-09-18
- Expected to finish
- 2025-12-20
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 80 years
- Low risk papillary thyroid cancer or highly suspicious for cancer
- Low risk papillary thyroid cancer
- cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
- cN0: No evidence of lymph node metastasis on ultrasound
- cM0: No evidence of distant metastasis on imaging
- Highly suspicious for cancer
- Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
- Nodule size 4 cm and smaller
- Limited to the thyroid on ultrasound
- No evidence of suspicious lymph nodes
- No evidence of thyroid cancer outside of the neck
- Referred for surgical consultation.
You may not qualify if…
- History of previous thyroid cancer or thyroid surgery and parathyroid surgery
- Non-English speaking
- Deaf
- Subject Selection (for Surgeons)
- Surgeon Inclusion Criteria
- Performs at least one thyroid surgery annually on adults
- Credentialed at Michigan Medicine
- Surgeon Exclusion Criteria
- None
Where it is running
- The University of Michigan Cancer Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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