Clinical trial NCT06853925: Testing a Web-based Intervention for Radioactive Iodine Symptom Management (RAI Support) to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients
Official title: A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Neoplasms
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
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (Retention and Engagement)
timeFrame: 4 weeks
measure: Acceptability (Quantitative)
timeFrame: 4 weeks
measure: Acceptability (Qualitative)
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.