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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Other: Usual Care
* Other: CQUPLE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day after clinic 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 time of surgery | 
| 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 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 |