Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later. Researchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.

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

• Patients aged 18 and older

• Patients diagnosed with intermediate risk DTC \< 6 months ago and who are making a decision about RAI treatment

• Ability to understand the information conveyed in the informed consent form, pose questions and process answers (e.g., no cognitive impairment per direct consultation with the patient's physician), and, finally, provided informed consent to participate.

• Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.

Locations
United States
Washington, D.c.
Lombardi Comprehensive Cancer Center
RECRUITING
Washington D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Virginia
Inova Health System
RECRUITING
Falls Church
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2032-05-15
Participants
Target number of participants: 408
Treatments
Active_comparator: Usual Care Condition
Patients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison.
Experimental: Decision Aid
Patients randomized in the RAI Decision website arm will receive information about intermediate risk DTC; treatment options for intermediate risk DTC following thyroidectomy; clarification of the decision to be made (to have RAI therapy or not); risks and benefits of each treatment option, including potential side effects related to salivary gland damage, lacrimal and nasal symptoms, delay in childbearing; clarification of values and preferences around treatment options; structured guidance around communication with the healthcare team and information to support decision-making about RAI.
Related Therapeutic Areas
Sponsors
Leads: Georgetown University
Collaborators: National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov