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

NCT ID: NCT06073223

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-12-20

Brief Summary

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

Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CQUPLE Intervention

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.

Group Type: EXPERIMENTAL

CQUPLE

Intervention Type: OTHER

Our research team developed 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. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making.

Usual Care Control

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

Usual Care

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

Intervention Type: OTHER

CQUPLE

Our research team developed 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. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making.

Intervention Type: OTHER

Eligibility 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.

• Performs at least one thyroid surgery annually on adults
• Credentialed at Michigan Medicine

Exclusion Criteria

• History of previous thyroid cancer or thyroid surgery and parathyroid surgery
• Non-English speaking
• Deaf

Subject Selection (for Surgeons)

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Pitt

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

The University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00218043

Identifier Type: OTHER

Identifier Source: secondary_id

R03CA283105

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2023.009

Identifier Type: -

Identifier Source: org_study_id