Clinical trial · Interventional
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CQUPLE | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CQUPLE Intervention
- description
- A novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon.
- interventionNames
- Other: CQUPLE
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Control
- description
- The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
- interventionNames
- Other: Usual Care
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
* NoneReferences
Publications (0)
Data not yet available