COMPLETED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-18
Study Completion:2025-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06073223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 80 years
  2. * Low risk papillary thyroid cancer or highly suspicious for cancer
  3. * Low risk papillary thyroid cancer
  4. * cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
  5. * cN0: No evidence of lymph node metastasis on ultrasound
  6. * cM0: No evidence of distant metastasis on imaging
  7. * Highly suspicious for cancer
  8. * Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
  9. * Nodule size 4 cm and smaller
  10. * Limited to the thyroid on ultrasound
  11. * No evidence of suspicious lymph nodes
  12. * No evidence of thyroid cancer outside of the neck
  13. * Referred for surgical consultation.
  1. * History of previous thyroid cancer or thyroid surgery and parathyroid surgery
  2. * Non-English speaking
  3. * Deaf
  4. * Performs at least one thyroid surgery annually on adults
  5. * Credentialed at Michigan Medicine
  6. * None

Contacts and Locations

Principal Investigator

Susan Pitt
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

The University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Susan Pitt, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-18
Study Completion Date2025-12-20

Study Record Updates

Study Start Date2023-09-18
Study Completion Date2025-12-20

Terms related to this study

Additional Relevant MeSH Terms

  • Thyroid Cancer