Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Thyroid Cancer

Treatments: Other: CQUPLE; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06073223

UMCC 2023.009

R03CA283105 (U.S. NIH Grant/Contract)

HUM00218043 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

CQUPLE Intervention

Experimental group

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.

Treatment:

Other: CQUPLE

Usual Care Control

Active Comparator group

Description:

The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.

Treatment:

Other: Usual Care