A Brief Video Intervention to Improve Patient Outcomes Following Radioiodine Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Auckland, New Zealand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Completed previous radioiodine treatment
Self-reported difficulty completing questionnaires
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention Video
BehavioralParticipants 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.
Control Video
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention VideoExperimental treatment 1 intervention
Group B: Control VideoActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-treatment functional Interference
Patient-reported functional interference following radioiodine treatment, assessed using a Functional Interference Questionnaire adapted from standard symptom interference measures. Participants rate the extent to which treatment-related effects interfere with daily activities including work, household tasks, and social participation. Each item is rated on a numeric rating scale from 0 to 10, where 0 = No interference, and 10 = Complete interference (i.e., higher scores indicate worse functioning or greater interference). A mean functional interference score will be calculated across items.
Time frame
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.2
Symptom Attribution to Treatment
Symptom attribution assessed using the Side Effect Attribution Scale (SEAS), which measures the extent to which participants attribute experienced symptoms to radioiodine treatment rather than to other causes. Participants rate attribution for 52 symptoms using a a 5-point Likert scale (i.e., 1-5 range): 1. = Definitely not a side effect 2. = Probably not a side effect 3. = Unsure 4. = Probably a side effect 5. = Definitely a side effect Higher scores indicate greater attribution of symptoms to treatment, whilst scores near 3 indicate uncertainty. A total attribution score is calculated by averaging responses across all symptoms.
Time frame
Pre-dose (1-3 weeks prior to treatment), post-dose (approximately 5-7 days post-dose), and 4-week follow-up.3
Adherence to Radiation Safety Precautionary Behaviours
Self-reported adherence to recommended radioiodine radiation safety precautionary behaviours (e.g., distancing, hygiene practices), assessed using a structured adherence questionnaire developed for this study. Adherence is quantified as a composite adherence score, calculated as the proportion of prescribed precautionary behaviours adhered to, with values ranging from 0 to 100%, where higher scores indicate greater adherence.
Time frame
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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