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

Not Applicable

Not yet recruiting

• Conditions: Thyroid Neoplasms

• Registration Number: NCT06853925
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-06-01
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility (Retention and Engagement)	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)	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)	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 Outcome Measures

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