Web-based Intervention for Thyroid Cancer

(RAI Support Trial)

Overseen By Valeria Gómez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Cognitive, Psychiatric, Hearing problems, others

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online tool can help adults with differentiated thyroid cancer feel better after receiving radioactive iodine treatment. The tool, called RAI Support, provides educational resources and symptom management strategies. Researchers will compare it to a typical cancer information website to assess whether RAI Support improves overall well-being. Participants should have undergone thyroid cancer treatment within the last three years and experience mild to moderate symptoms related to their treatment. As an unphased trial, this study allows participants to contribute to innovative research that could enhance support for others with similar experiences.

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 focuses on using an online tool to help manage symptoms after thyroid cancer treatment.

What prior data suggests that the RAI Support intervention is safe for thyroid cancer patients?

Research has shown that online tools can be safe for patients. The RAI Support tool helps thyroid cancer survivors manage symptoms after radioactive iodine (RAI) treatment. RAI treatment has been extensively studied, and research indicates it does not significantly increase the risk of developing other cancers, except possibly thyroid cancer. This suggests the treatment is generally well-tolerated.

The RAI Support tool is easy to use and understand, offering videos, infographics, and other resources to help manage symptoms like dry mouth. Although the tool is new, doctors have approved the content, making it a safe and supportive option for those who have had RAI treatment. This trial aims to assess how well people can use this tool and whether it improves their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Radioactive Iodine (RAI) Support intervention because it offers a fresh, patient-centered approach to managing thyroid cancer treatment. Unlike traditional educational resources, RAI Support uses multimedia content, including videos and infographics, designed at an accessible reading level to cater to diverse patient backgrounds. This web-based tool also includes interactive features like clinician-led activities and stress-management resources, aiming to enhance patient understanding and engagement in their care. By integrating these unique elements, RAI Support has the potential to improve symptom management and patient outcomes more effectively than standard text-based information sources.

What evidence suggests that the RAI Support intervention is effective for improving quality of life in thyroid cancer patients?

This trial will compare a web-based intervention, Radioactive Iodine Support (RAI Support), with Treatment as Usual (TAU) using the American Cancer Society website. Research has shown that radioactive iodine (RAI) therapy effectively treats differentiated thyroid cancer. Studies have found that patients receiving RAI therapy often achieve better cancer control and many live longer. For high-risk patients, RAI therapy can increase survival rates by up to 30.9%. It also reduces the likelihood of cancer recurrence, particularly in the first two years after treatment. Overall, RAI is a proven method for effectively managing thyroid cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Alaina Carr, PhD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

Adults over 18 with differentiated thyroid cancer who had radioactive iodine treatment within the last three years. Participants should have mild to moderate symptoms, be able to understand English, and have internet access for using a digital tool aimed at improving quality of life.

Inclusion Criteria

I have a device with internet to use.

I am 18 or older with papillary or follicular carcinoma.

I have been diagnosed with differentiated thyroid cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to RAI Support or an informational website for four weeks and use the assigned website once a week

4 weeks

4 visits (virtual)

Follow-up

Participants complete online questionnaires about symptoms, mood, and confidence in managing symptoms, and may participate in an optional virtual interview

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Radioactive Iodine Support (RAI Support)

Trial Overview The trial is testing an online tool called RAI Support against usual care (an informational website) to see if it can improve health-related quality of life after radioactive iodine treatment. Patients will use their assigned website weekly and complete questionnaires about their well-being.

How Is the Trial Designed?

Group I: Treatment as usual (TAU) Experimental Treatment 1 Intervention

The American Cancer Society (ACS) website on Radioactive Iodine (Radioiodine)Therapy for Thyroid Cancer is the TAU comparison. This website is a reputable and trusted source of information about cancer, with relevant content and web availability. Using the ACS website allows participants in both groups to receive information (addressing ethical concerns) through a website (similar delivery mode for information).

Group II: Radioactive Iodine Support (RAI Support) Experimental Treatment 1 Intervention

RAI Support consists of multimedia content (images, videos, text, audio, and infographics across different website pages) that is written at an 8th grade reading level. RAI Support uses patient materials that are visually diverse to appeal to patients from different racial and ethnic backgrounds and inclusion of all genders. RAI Support users can access short (\~3 minutes or less) clinician-approved symptom management education videos and follow clinician-led video-guided activities such as nutrition management for dry mouth. In addition, RAI Support contains infographic pages about specific symptoms of RAI (e.g., salivary, lacrimal, and nasal symptoms with strategies for symptom management) and a resources page consisting of a printable treatment summary and survivorship plan to bring to provider appointments and access to evidence-based stress-management resources such as relaxation recordings.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452844/

Comparing therapeutic outcomes: radioactive iodine therapy ... The majority of patients underwent RAI therapy (76.3%). Most patients had a good biochemical (68.4%, p = 0.246) and structural control (72.4%, p ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/4/525

A SEER-Based Study Covering Histologic Subtypes and ... The relative survival rate is higher or tends to be higher in most subgroups undergoing RAI therapy than in subgroups not undergoing RAI therapy.

3. snmmi.org snmmi.org/Web/Web/News/Articles/Radioiodine-Therapy-Improves-Relative-Survival-Rates-of-Differentiated-Thyroid-Cancer-Patients.aspx

Radioiodine Therapy Improves Relative Survival Rates of ... In high-risk differentiated thyroid cancer, benefits in relative survival of up to 30.9 percent were observed. For larger tumor size or lymph ...

4. jenci.springeropen.com jenci.springeropen.com/articles/10.1186/s43046-025-00293-z

Effectiveness of radioiodine therapy on preventing recurrence ... RAI therapy shows potential in reducing recurrence in DTC, particularly within the first 2-year post-treatment, but its effect on overall survival remains ...

5. thyroid.org thyroid.org/patient-thyroid-information/ct-for-patients/february-2019/vol-12-issue-2-p-10-11/

Low dose radioactive iodine is as effective as high ... Low dose radioactive iodine ablation therapy is equivalent to higher doses in patients with low risk thyroid cancer in terms of recurrence and survival.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8449277/

Cancer Risk After Radioactive Iodine Treatment for ... RAI therapy was not associated with a significant increase in overall cancer risk or site-specific cancer incidence or mortality, except for thyroid cancer.

7. 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.

8. thyroid.org thyroid.org/patient-thyroid-information/ct-for-patients/january-2023/vol-16-issue-1-p-7-8/

Cancer risk following radioiodine treatment of ... This data shows that there overall no increased risk of cancer after treating patients with hyperthyroidism with radioactive iodine therapy.

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00013

Radioactive Iodine: Recognizing the Need for Risk-Benefit ... This results in a modestly positive association of the risk of death from solid cancer, with a small but significant total of 20-30 lifetime ...