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Behavioural Intervention

CQUPLE Intervention for Thyroid Cancer

N/A

Recruiting

Led By Susan Pitt

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low risk papillary thyroid cancer or highly suspicious for cancer

Low risk papillary thyroid cancer: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound, No evidence of lymph node metastasis on ultrasound, No evidence of distant metastasis on imaging

Must not have

History of previous thyroid cancer or thyroid surgery and parathyroid surgery

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new intervention for 50 patients newly diagnosed with thyroid cancer to help them make informed decisions about their treatment.

Who is the study for?

This trial is for individuals aged 18-80 with low-risk papillary thyroid cancer. Eligible participants should have a tumor size of up to 4 cm, confined to the thyroid, no lymph node metastasis or distant spread based on imaging. They must be referred for surgical consultation and not have had previous thyroid/parathyroid surgery, nor be non-English speaking or deaf.

What is being tested?

The study compares two approaches in treating low-risk thyroid cancer: 'CQUPLE' intervention versus usual care. CQUPLE involves specific information delivery before a surgeon visit while usual care does not provide extra information. Participants are randomly assigned to one of these groups and their treatment choices are recorded.

What are the potential side effects?

Since this trial focuses on the decision-making process rather than direct medical treatments, there aren't traditional side effects involved. However, receiving more or less information could impact patients' stress levels and confidence in their treatment choice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thyroid cancer is low risk or highly suspected to be cancerous.

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My thyroid cancer is small, within the thyroid, and hasn't spread.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had thyroid cancer or surgery on my thyroid or parathyroid.

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I do not speak English.

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I am deaf.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day after clinic visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day after clinic visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and day after clinic visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the CQUPLE intervention to patients

Acceptability of the CQUPLE intervention to providers

Feasibility of the CQUPLE intervention (burden of data collection on study team)

+2 more

Secondary study objectives

Effect of CQUPLE on patient treatment choice

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CQUPLE InterventionExperimental Treatment1 Intervention

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.

Group II: Usual Care ControlActive Control1 Intervention

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

0 / 6Eligibility criteria met