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NCT Number: NCT06853925

Testing a Web-based Intervention for Radioactive Iodine Symptom Management to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients

The goal of this clinical trial is to learn if adult patients diagnosed with differentiated thyroid cancer can easily use and benefit from an online tool aimed to provide patients with educational resources and symptom management strategies to improve their quality of life after radioactive iodine (RAI) treatment. The main questions it aims to answer are:

1. Can patients easily use and benefit from the RAI Support intervention? 2. Does RAI Support improve health-related quality of life (overall well-being) compared to usual care?

This research will help test better digital tools to support thyroid cancer survivors in managing their health after RAI treatment.

Researchers will compare RAI Support to treatment as usual (a publicly available informational website about thyroid cancer) to see if RAI Support works to improve patients' overall well-being.

Participants will:

1. Receive access to RAI Support or an informational website (treatment as usual) for four weeks. 2. Use the assigned website once a week for up to four weeks. 3. Complete two online questionnaires (an initial questionnaire and a final questionnaire after four weeks of using the assigned website) about symptoms related to RAI treatment, mood, and confidence in managing symptoms. 4. Complete an optional 60 minute virtual interview about your experiencing using the assigned website.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location status: Recruiting

Location contact

Alaina Carr PI, PhD

CONTACT

[email protected]

202-687-0958

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older (papillary or follicular carcinoma)
  • Diagnosed with differentiated thyroid cancer
  • Received radioactive iodine (RAI) treatment less than or equal to three years ago.
  • Mild to moderate symptoms of RAI
  • Able to provide informed consent in English
  • Access to a computer, tablet, or smartphone with internet connectivity

Exclusion criteria

  • A condition that precludes providing informed consent or completing study procedures (cognitive or psychiatric condition, hearing problems) as identified by the patient's physician or as assessed by a trained study team member.

Treatment and study plan

Radioactive Iodine Support (RAI Support)

Behavioral

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.

Treatment as usual (TAU)

Other

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).

Primary outcomes

  1. Feasibility (Retention and Engagement)

    Time frame: 4 weeks

    Feasibility is defined by at least 86% of patients are retained and complete the 4-week post-assessment. Feasibility is also defined as greater or equal to 70% RAI Support engagement rate (greater or equal to 3/4 website sections).

  2. Acceptability (Quantitative)

    Time frame: 4 weeks

    Acceptability will be assessed using the Acceptability of Intervention Measure (AIM). AIM is a 4-item questionnaire that assesses the acceptability of an intervention. Each item is on a 5-point Likert scale (1=Completely disagree; 5= Completely agree). Higher scores indicate greater acceptability.

  3. Acceptability (Qualitative)

    Time frame: 4 weeks

    Acceptability will also be assessed from qualitative feedback gathered from participants in the RAI Support intervention condition. Up to 20 RAI Support completers will be asked to complete an individual exit interview with the PI or a trained study team member to elicit feedback on the helpfulness of the intervention, participant burden, barriers to intervention participation, satisfaction with components of the intervention, and satisfaction with the delivery, modality, and length of the intervention.

Secondary outcomes

  1. Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life)

    Time frame: 4 weeks

    The Functional Assessment of Cancer Therapy- General-7 (FACT-G7) questionnaire consists of 7 items assessing the physical, emotional, and functional well-being of adult cancer patients. Each item is on a five-point Likert scale (0= Not at all; 4= Very much). Scores range from 0-28. Higher scores are indicative of better HRQOL.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaina L Carr, PhD

CONTACT

[email protected]

202-687-0958

Valeria Gómez, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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