Decision Aid for Thyroid Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Low/high risk DTC, prior RAI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

408 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for people recently diagnosed with intermediate-risk differentiated thyroid cancer. Participants should be deciding about radioactive iodine treatment and willing to use a website to help make their decision. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I understand the study information and can make decisions about my care.

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

I was diagnosed with intermediate risk thyroid cancer less than 6 months ago and am considering radioactive iodine treatment.

Exclusion Criteria

My thyroid cancer is classified as low or high risk.

I have previously received radioactive iodine treatment.

I cannot undergo RAI treatment due to conditions like pregnancy or low white blood cell count.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Decision Aid Intervention

Participants receive either a decision aid website or usual care website to help make informed decisions about RAI treatment

4 weeks

Online access

Follow-up

Participants are monitored for informed choice, knowledge, decisional conflict, and satisfaction with decision

6 months

Surveys at baseline, 1 week, 4 weeks, and 6 months

Treatment Details

Interventions

• Decision Aid

Trial Overview The study tests if a decision aid (DA) website can help thyroid cancer patients understand RAI treatment better than usual care. The DA includes interactive tools and personalized information, while the control group uses a basic ACS website without these features.

Participant Groups

Group I: Decision Aid Experimental Treatment 1 Intervention

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.

Group II: Usual Care Condition Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+