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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaina L Carr, PhD | Contact | 202-687-0958 | cancercarestudy@georgetown.edu | |
| Valeria Gómez, BS | Contact | cancercarestudy@georgetown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alaina Carr, PhD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39937181 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2025 | Jan 14, 2026 |
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|
| 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). |
|
| 4 weeks |
| ICF_002.pdf |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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