To hear about similar clinical trials, please enter your email below
Trial Title:
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
NCT ID:
NCT06073223
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
The control group will be blinded to the intervention and receive usual care, which
involves providing no disease or treatment specific information outside the surgeon
visit.
Intervention:
Intervention type:
Other
Intervention name:
Usual Care
Description:
The control group will receive usual care, which involves providing no disease or
treatment specific information outside the surgeon visit.
Arm group label:
Usual Care Control
Intervention type:
Other
Intervention name:
CQUPLE
Description:
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.
Arm group label:
CQUPLE Intervention
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Michigan Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katy Jensen
Phone:
734-764-5424
Email:
gensurgadmin-choiceresearchteam@med.umich.edu
Investigator:
Last name:
Susan Pitt, MD
Email:
Principal Investigator
Start date:
September 18, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073223
