Decision Aid for Thyroid Cancer

Recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special website can assist people with thyroid cancer in making better decisions about radioactive iodine (RAI) treatment. It will compare the effectiveness of this decision aid, a specialized online tool, against standard information on the American Cancer Society website. The trial targets individuals diagnosed with intermediate-risk differentiated thyroid cancer (DTC) within the last six months who are considering RAI treatment. Participants will use either the decision aid website, featuring interactive tools and personalized guidance, or the ACS website, which provides basic information. As an unphased trial, this study allows participants to contribute to research that could enhance decision-making tools for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your medications might interact with the study.

What prior data suggests that this decision aid is safe for patients with thyroid cancer?

Past research has found that tools called decision aids are clear, balanced, and helpful for patients with differentiated thyroid cancer (DTC). These tools assist patients in understanding their treatment options, such as radioactive iodine (RAI) therapy, enabling informed choices. Decision aids are not treatments and therefore do not carry risks or side effects like medicines or medical procedures. Instead, they provide structured guidance and information to facilitate discussions with healthcare teams, helping patients make decisions aligned with their personal values and preferences. Overall, using a decision aid is safe for patients, as it offers additional support and information during the decision-making process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for thyroid cancer because it aims to empower patients with intermediate risk differentiated thyroid cancer (DTC) by providing detailed, personalized information and support for making informed decisions about radioactive iodine (RAI) therapy. Unlike standard care, which often involves general information from resources like the American Cancer Society, this Decision Aid offers specific insights into treatment options, potential side effects, and personal values clarification. By enhancing communication with healthcare teams and supporting decision-making, this approach could lead to more patient-centered care and better alignment with individual preferences and needs.

What evidence suggests that this decision aid is effective for making informed decisions about RAI treatment for thyroid cancer?

This trial will compare the effectiveness of a Decision Aid with Usual Care for patients with thyroid cancer. Research has shown that decision aids can help these patients make informed treatment choices. One study found that a decision aid was clear, fair, and useful for patients selecting their treatment options. Another review emphasized the importance of these tools in helping patients understand their choices and align them with personal values. Using decision aids links to better decision-making by providing clear guidance and information, leading to more informed and confident treatment decisions for patients with thyroid cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10264809/

Patient decision aids for patients with differentiated thyroid ... Evidence-based PtDAs were created for patients with DTC for two different treatment decisions. Our final version was judged to be clear, balanced, and helpful ...

2. aot.amegroups.org aot.amegroups.org/article/view/7207/html

A narrative review of decision aids for low-risk thyroid cancer Indeed, the 5-year overall survival rate for papillary thyroid cancer (PTC) is outstanding: 97% for all stages and 100% for patients with disease localized to ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2770969

Novel Decision Support Interventions for Low-risk Thyroid ... This quality improvement study examines a patient-oriented intervention to support decision-making about low-risk thyroid cancer treatment.

4. nature.com nature.com/articles/s41598-024-72002-0

Assessing radioiodine therapy long-term outcomes in ... This study explored the role of radioiodine therapy (RAI) in low-risk thyroid cancer patients and examined the disease-specific survival (DSS) rates.

5. liebertpub.com liebertpub.com/doi/10.1177/10507256251363120

2025 American Thyroid Association Management ... This document is intended to inform clinical decision-making using the DATA framework for patients as they proceed through their individual journey with ...

6. academic.oup.com academic.oup.com/jcem/article/104/9/4087/5380478

Risk Stratification in Differentiated Thyroid Cancer This review examines the critical role of ongoing risk stratification from the time of detection through final follow-up in differentiated thyroid cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12515032/

Development of a Decision Aid for Patients With Low‐Risk ... Development of a Decision Aid for Patients With Low‐Risk Thyroid Cancer: A Mixed‐Methods Analysis of Feedback From Both Patient and Clinicians - PMC.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804922013405

Position paper from the Endocrine Task Force of ... Differentiated non-medullary thyroid carcinoma (DTC) is the most common endocrine malignancy. The incidence of DTC has increased worldwide during the last ...