A Brief Video Intervention to Improve Patient Outcomes Following Radioiodine Treatment

Официальное название

Testing a Brief Video Intervention to Support Patient Coping Following Radioiodine Treatment

Обзор

This study will test the impact of a short video intervention for people who are receiving radioiodine treatment for thyroid conditions (such as hyperthyroidism or thyroid cancer). After their single-dose treatment, patients need to follow safety instructions to protect others and manage side effects during recovery. Some people find these instructions hard to remember, and side effects (or anticipation of side effects) can feel worrying or disruptive. The video aims to present the treatment information in a more accessible patient-friendly way, so that patients feel less distressed, find their side effects easier to cope with, and better engage with safety precautions. All patients will first have a pre-treatment consultation with their doctor and receive the standard treatment information currently provided. Before this consultation patients will be randomly assigned to view one of two videos. The control group will see a neutral video that details standard health information that is not specific to radioiodine, while the intervention group will see a video that explains side effects, safety requirements and recovery period in a more adaptive way. Comparing these two groups will allow us to assess whether this new approach improves coping, reduces distress, and enhances adherence to safety instructions in the post-dose recovery phase of radioiodine treatment.

Подробное описание

This study is a two-arm randomised controlled trial. Prior to treatment, participants will be randomly assigned to one of two arms. The control group will view a neutral video that discusses general health advice unrelated to the radioiodine treatment, while the intervention group will view a video that reframes side effects and safety instructions in a more adaptive way. All participants will receive a standard pre-treatment consultation with their doctor and the usual written information. Outcomes will then be compared between the two groups in terms of side effects, disability and understanding of treatment precautions. To control for expectation effects both groups will be told that we are testing different videos to assist patients with the radioiodine treatment. This study aims to find out whether a short video intervention (1) helps patients cope better with side effects and get back to normal activities more quickly, (2) improves how well patients remember and understand the safety instructions they need to follow after their dose, (3) reduces disability related to the treatment and its side effects. By examining whether a brief video intervention improves coping with side effects, understanding of safety instructions, and post-treatment recovery, the research will provide new knowledge on how information about radioiodine can be delivered more effectively.

Вмешательства

• Поведенческое Intervention Video
  Participants will view a brief prerecorded video (approximately 4 minutes) online, delivered through Qualtrics, following completion of the baseline questionnaire. The intervention video will present information on radioiodine treatment recovery, managing treatment side effects, and radiation safety requirements. The video will be delivered online prior to the participant's radioiodine treatment, using patient-friendly language and supportive framing.
• Поведенческое Control Video
  Participants will view a brief prerecorded neutral video (approximately 4 minutes) online, being delivered through Qualtrics following the baseline questionnaire. The control video will present general health information unrelated to radioiodine treatment (e.g., healthy lifestyle topics such as nutrition and stress management). The video will be delivered online prior to the participant's radioiodine treatment, and will match the intervention video in duration, format, and presenter.

Первичные конечные точки

• Post-treatment functional Interference [Срок оценки: From treatment to post-treatment questionnaire (on the last day of radiation safety requirements; approximately 5-7 days post-dose) and at 4-week follow-up.]
• Symptom Attribution to Treatment [Срок оценки: Pre-dose (1-3 weeks prior to treatment), post-dose (approximately 5-7 days post-dose), and 4-week follow-up.]
• Adherence to Radiation Safety Precautionary Behaviours [Срок оценки: From treatment to post-treatment questionnaire (on the last day of radiation safety requirements; approximately 5-7 days post-dose) and at 4-week follow-up.]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Clinical diagnosis of hyperthyroidism or thyroid cancer
• Scheduled to receive radioiodine therapy at Auckland City Hospital Radiation Oncology Clinic
• Able to understand and communicate in English
• Access to an internet-connected device to complete study questionnaires

Критерии исключения

• Completed previous radioiodine treatment
• Self-reported difficulty completing questionnaires

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07405320 · 24301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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