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NCT06073223 | RECRUITING | Thyroid Cancer

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

University of Michigan Rogel Cancer Center

Brief 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.

Condition or disease

Thyroid Cancer

Intervention/treatment

Usual Care

CQUPLE

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : SINGLE
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.
Primary Purpose : TREATMENT
Official Title : Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Actual Study Start Date : 2023-09-18
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

Location Details

NCT06073223

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Locations

RECRUITING

United States, Road cancer

The University of Michigan Cancer Center

Ann Arbor, Road cancer, United States, 48109