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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer
• Intervention / Treatment: Other: CQUPLE; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Usual Care Control; The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.	Other: Usual Care; The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the CQUPLE intervention (recruitment)	Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.	up to 7 days after surgery
Feasibility of the CQUPLE intervention (retention)	Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.	up to 7 days after surgery
Feasibility of the CQUPLE intervention (burden of data collection on study team)	To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.	up to 7 days after surgery
Acceptability of the CQUPLE intervention to patients	This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.	up to 14 days after visit
Acceptability of the CQUPLE intervention to providers	This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.	at 6 months, and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of CQUPLE on patient treatment choice	The investigators will assess patient's intended treatment choice at baseline and pre-visit. The investigators will assess actual treatment choice post-visit. The investigators will ask: "Knowing what you know now, which treatment option would/did you choose for yourself?" Answers will include: removal of the entire thyroid, removal of half of the thyroid, surveillance with ultrasound.	baseline, pre-visit and post visit- up to 7 days

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Pitt, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: UMCC 2023.009; HUM00218043 (Other Identifier: University of Michigan); R03CA283105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will make de-identified data available on a by request basis and will require a DUA
• IPD Sharing Time Frame: A data set comprised of survey data, interview and conversation transcripts, and metadata will be made available for non-profit research purposes within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
• IPD Sharing Access Criteria: The data set will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No