Recruiting

RAI vs. Decision Aid

Sponsor:

Georgetown University

Code:

NCT06980103

Conditions

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision Aid

Usual Care

Study Details

Brief 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.

Conditions

Thyroid Cancer

Study ID

NCT06980103

Start date

Aug 6, 2025

Status verified date

Jan, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnosis of low risk or high risk DTC
  • Prior history of RAI
  • Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)

Study Design

Enrollment

408 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Decision Aid

The study intervention is a web-based decision aid (DA) developed by the study team. The Radioactive Iodine Decisions decision aid is designed as an educational tool to help patients have information about Radioactive Iodine and encourage them to talk with their medical team about this treatment decision.

Usual Care

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.

Primary outcome measure

  • Informed choice about RAI treatment [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

Lombardi Comprehensive Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Lourdes M Inbar-Albo, MD,MSc. Project Director

202-687-3628thyroidcancerstudy@georgetown.edu

Jacqueline Jonklaas, MD

202-687-3628jonklaaj@georgetown.edu

Principal Investigator:

Jacqueline Jonklaas, MD, PhD, MPH

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Leila Shobab, MD

202-877-0526Leila.Shobab@medstar.net

Inova Health System

Recruiting

Falls Church, Virginia, United States, 22031

Contacts

Samantha Diamond, MD

‭703-776-3574‬Samantha.Diamond-rossi@inova.org

More Information

Sponsor

Georgetown University

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Decision Aid
  • Radioactive Iodine Treatment
  • Thyroid Cancer
  • Intermediate Risk
  • Differentiated Thyroid Cancer
  • Intermediate risk DTC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-01-08.