Thyroid NeoplasmsNCT06853925
Testing a Web-based Intervention for Radioactive Iodine Symptom Management to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients
A study testing Radioactive Iodine Support (RAI Support) and Treatment as Usual (TAU) in people with Thyroid Neoplasms, run by Georgetown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Radioactive Iodine Support (RAI Support) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valeria Gómez, BS contact
United States1 site, 1 recruiting
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Alaina Carr PI, PhD, 202-687-0958, alc343@georgetown.edu
About this study
Official title: A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer
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:
- Can patients easily use and benefit from the RAI Support intervention?
- Does RAI Support improve health-related quality of life (overall well-being) compared to usual care?
Read more
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:
- Receive access to RAI Support or an informational website (treatment as usual) for four weeks.
- Use the assigned website once a week for up to four weeks.
- 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.
- Complete an optional 60 minute virtual interview about your experiencing using the assigned website.
- Conditions
- Thyroid Neoplasms
- Being tested
- Radioactive Iodine Support (RAI Support), Treatment as Usual (TAU)
- Keywords
- symptom burden, self efficacy, feasibility studies, internet-based intervention, pilot projects, neoplasms, radioactive iodine treatment, iodine radioisotopes, health-related quality of life, informational needs
- Medical subject headings
- Thyroid Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Iodine Support (RAI Support)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Treatment as Usual (TAU) |
| Radioactive Iodine Support (RAI Support) | Experimental | 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. Receives: Behavioral: Radioactive Iodine Support (RAI Support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Retention and Engagement)
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).
Measured: 4 weeks
Acceptability (Quantitative)
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.
Measured: 4 weeks
Acceptability (Qualitative)
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.
Measured: 4 weeks
Secondary outcomes (1)
Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start2 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaina Carr, Georgetown University
- Investigators
- Alaina Carr, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853925
- Sponsor's protocol ID
- 00008478
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06853925
- Acronym / sponsor ID
- 00008478
- Conditions
- Thyroid Neoplasms
- Keywords
- symptom burden, self efficacy, feasibility studies, internet-based intervention, pilot projects, neoplasms, radioactive iodine treatment, iodine radioisotopes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can patients easily use and benefit from the RAI Support intervention?
- 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:
- Receive access to RAI Support or an informational website (treatment as usual) for four weeks.
- Use the assigned website once a week for up to four weeks.
- 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.
- Complete an optional 60 minute virtual interview about your experiencing using the assigned website.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Other | Other: 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). |
| Radioactive Iodine Support (RAI Support) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Radioactive Iodine Support (RAI Support) |
| 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). | Other | Treatment as usual (TAU) |
Primary outcome
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).
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.
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.
1 secondary outcome
Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Thyroid Neoplasms
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Studies on Tumors of the Thyroid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valeria Gómez, BS contact
Alaina Carr, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive Iodine Support (RAI Support) and Treatment as Usual (TAU) in people with Thyroid Neoplasms, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaina L Carr, PhD (202-687-0958, cancercarestudy@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Retention and Engagement) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.