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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06980103
Status
Recruiting
Apply to this trial

Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decision Aid — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 6, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
408 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Lourdes M Inbar-Albo, MD,MSc. Project Director
[email protected]
202-687-3628
Jacqueline Jonklaas, MD
[email protected]
202-687-3628
Jacqueline Jonklaas, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Kristi D Graves, Ph.D. (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Leila Shobab, MD
[email protected]
202-877-0526
Leila Shobab, MD, Assistant Professor (SUB_INVESTIGATOR)
Inova Health SystemFalls ChurchVirginia22031
Samantha Diamond, MD
[email protected]
‭703-776-3574‬
Samantha Diamond-Rossi, MD (SUB_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCMedStar Washington Hospital Center· Washington D.C., DCInova Health System· Falls Church, VA

Related Studies