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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
The University of Michigan Cancer Center
RECRUITING
Ann Arbor
Contact Information
Primary
Katy Jensen
gensurgadmin-choiceresearchteam@med.umich.edu
734-764-5424
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2025-10
Participants
Target number of participants: 70
Treatments
Experimental: CQUPLE 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.
Active_comparator: Usual Care Control
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov