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

Not Applicable

Recruiting

• Conditions: Thyroid Cancer
• Interventions: Other: Usual Care; Other: CQUPLE

• Registration Number: NCT06073223
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-18
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Control	Usual Care	The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
CQUPLE Intervention	CQUPLE	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of the CQUPLE intervention to patients	day after clinic visit	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.
Feasibility of the CQUPLE intervention (burden of data collection on study team)	up to 7 days after surgery	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.
Acceptability of the CQUPLE intervention to providers	at time of surgery	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.
Feasibility of the CQUPLE intervention (recruitment)	up to 7 days after surgery	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.
Feasibility of the CQUPLE intervention (retention)	up to 7 days after surgery	Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.

Secondary Outcome Measures

Name	Time	Method
Effect of CQUPLE on patient treatment choice	baseline, pre-visit and post visit- up to 7 days	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.

Trial Locations

Locations (1)

The University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States