An interventional study of Usual Care and CQUPLE in Thyroid Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Treatment
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.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 50 is close to the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
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Low risk papillary thyroid cancer or highly suspicious for cancer
Low risk papillary thyroid cancer
Highly suspicious for cancer
Exclusion Criteria:
Subject Selection (for Surgeons)
Surgeon Inclusion Criteria
Surgeon Exclusion Criteria
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 7 days after surgery
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.
Time frame: baseline, pre-visit and post visit- up to 7 days
Plan to share: Yes — The investigators will make de-identified data available on a by request basis and will require a DUA
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center