Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
NCT06073223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-17
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
Interventions
- OTHER
-
Usual Care
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
- 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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Susan Pitt · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-18
- Primary Completion
- 2025-12-20
- Completion
- 2025-12-20
Countries
- United States
Study Locations
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