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

NCT ID: NCT06853925

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Treatment as usual (TAU)

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 Type OTHER

Treatment as Usual (TAU)

Intervention Type 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).

Radioactive Iodine Support (RAI Support)

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.

Group Type EXPERIMENTAL

Radioactive Iodine Support (RAI Support)

Intervention Type 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.

Interventions

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Radioactive Iodine Support (RAI Support)

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.

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Alaina Carr

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaina Carr, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alaina L Carr, PhD

Role: CONTACT

202-687-0958

Valeria Gómez, BS

Role: CONTACT

Facility Contacts

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Alaina Carr PI, PhD

Role: primary

202-687-0958

References

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Carr AL, Jenkins AM, Jonklaas J, Gabriel K, Miller K, Graves K. Patient and Provider Perspectives of a Web-based Intervention to Support Symptom Management after Radioactive Iodine Treatment for Differentiated Thyroid Cancer: Qualitative Study. JMIR Form Res. 2025 Feb 12. doi: 10.2196/60588. Online ahead of print.

Reference Type BACKGROUND
PMID: 39937181 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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00008478

Identifier Type: -

Identifier Source: org_study_id

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