Intervention to reduce overtreatment in low-risk thyroid cancer patients
Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
This study tests if giving more information about treatment options can help low-risk thyroid cancer patients make better choices and avoid unnecessary treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06073223 on ClinicalTrials.gov |
What this trial studies
This study involves 50 patients aged 18 to 80 who have been newly diagnosed with low-risk thyroid cancer. Participants will be randomized into two groups: one receiving the CQUPLE intervention aimed at enhancing their understanding of treatment options, and the other receiving usual care without additional information. The study will assess patients' treatment choices and awareness before and after their surgical consultations. The goal is to evaluate whether the intervention can influence treatment decisions and reduce unnecessary overtreatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with low-risk papillary thyroid cancer or highly suspicious thyroid nodules.
Not a fit: Patients with a history of previous thyroid cancer or thyroid surgery, as well as non-English speakers and the deaf, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help patients make more informed treatment choices, potentially reducing unnecessary surgeries.
How similar studies have performed: Other studies have shown success in using educational interventions to improve patient decision-making in cancer treatment, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 this trial is running
Ann Arbor, Michigan
- The University of Michigan Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Susan Pitt — University of Michigan Rogel Cancer Center
- Study coordinator: Katy Jensen
- Email: gensurgadmin-choiceresearchteam@med.umich.edu
- Phone: 734-764-5424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.