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

NCT06073223 | Completed

• 3 other identifiers: UMCC 2023.009HUM00218043R03CA283105
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (1)

• Effect of CQUPLE on patient treatment choice

  baseline, pre-visit and post visit- up to 7 days

Study Arms (2)

CQUPLE Intervention

EXPERIMENTAL

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

Usual Care Control

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Usual Care OTHER

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

Usual Care Control

CQUPLE 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.

CQUPLE Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of previous thyroid cancer or thyroid surgery and parathyroid surgery
• Non-English speaking
• Deaf
• Subject Selection (for Surgeons)
• Performs at least one thyroid surgery annually on adults
• Credentialed at Michigan Medicine
• None

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Susan Pitt

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group will be blinded to the intervention and receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: September 18, 2023
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)