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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University

About 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 does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

408 Participants
are divided into 2 treatment groups
Group A: Usual Care ConditionActive comparator 1 intervention
Group B: Decision AidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Informed choice about RAI treatment

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.

Time frame
4 weeks

Secondary outcomes

1

Knowledge about RAI

Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.

Time frame
Baseline
2

Knowledge about RAI

Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.

Time frame
1 week
3

Knowledge about RAI

Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.

Time frame
4 weeks
4

Knowledge about RAI

Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.

Time frame
6 months

Other outcomes

Sponsors and contacts

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Georgetown University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator