Testing a Web-based Intervention for Radioactive Iodine Symptom Management to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Radioactive Iodine Support (RAI Support), Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Thyroid Neoplasms. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer
Обзор
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.
Вмешательства
- Поведенческое 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 nutr - Другое 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).
Первичные конечные точки
- Feasibility (Retention and Engagement) [Срок оценки: 4 weeks]
- Acceptability (Quantitative) [Срок оценки: 4 weeks]
- Acceptability (Qualitative) [Срок оценки: 4 weeks]
Вторичные конечные точки (1)
- Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life) [Срок оценки: 4 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Georgetown University — Washington D.C.
Публикации
- 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. PMID 39937181
Идентификаторы
NCT: NCT06853925 · 00008478