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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Effect of CQUPLE on patient treatment choice

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,191 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,371 Total Patients Enrolled

Susan PittPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to join this research endeavor?

"Clinicaltrials.gov confirms that this medical research is actively recruiting new participants, having been listed since October 1st 2023 and last updated on the 3rd of the same month."

Answered by AI

How many participants are engaging with the current study?

"Affirmative. Clinicaltrials.gov's information indicates that this clinical trial, first posted on October 1st 2023, is actively looking for participants. Seventy individuals must be recruited from a single site."

Answered by AI

Who qualifies for participation in this clinical research?

"The requirements for participation in this clinical trial are a diagnosis of thyroid cancer and being between the ages 18 to 80. 70 individuals need to be recruited before it can begin."

Answered by AI

Does this trial accept participants younger than two decades of age?

"As outlined in the study's eligibility requirements, participants must be aged between 18 and 80. Additionally, there are 33 separate studies for those below the age of consent as well as 229 trials available to individuals over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073223.

All > Thyroid Cancer