NCT06980103 · Georgetown University
Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Informed choice about RAI treatment
Time frame: 4 weeks
The primary outcome is informed choice measured with the Multi-Dimensional Measure of Informed Choice (MMIC). The scores for informed choice include two components: knowledge categorized as high/low based on the mid-point in the range of scores on the knowledge measure (minimum score of 0 and maximum score of 10; higher scores indicate greater knowledge) and values (attitudes) that are categorized as positive or negative based on the mid-point on the attitude items (minimum score of 4; maximum score of 28; higher scores more greater alignment of the RAI treatment decision with personal values. Informed choice is characterized as informed or uninformed. An informed choice means a decision based on high knowledge and values (attitudes) that align with the patient's preferences and final treatment decision. An uninformed choice occurs when a patient has low knowledge or makes a decision that doesn't match their personal values and attitudes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Washington D.C., District of Columbia
- Falls Church, Virginia
Collaborators
National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations