- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405320
A Brief Video Intervention to Improve Patient Outcomes Following Radioiodine Treatment
Testing a Brief Video Intervention to Support Patient Coping Following Radioiodine Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Niamh Orr-Walker
- Phone Number: 0211263070
- Email: norr242@aucklanduni.ac.nz
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Completed previous radioiodine treatment
- Self-reported difficulty completing questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Video
Participants assigned to the intervention group will view a brief video that explains radioiodine treatment, side effects, and radiation safety requirements using adaptive and supportive framing.
|
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.
|
|
Active Comparator: Control Video
Participants assigned to the control group will view a neutral video containing general health-related information unrelated to radioiodine treatment.
The video will be similar in length, style, and presenter to the intervention 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-treatment functional Interference
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.
|
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.
|
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
Time Frame: Pre-dose (1-3 weeks prior to treatment), post-dose (approximately 5-7 days post-dose), and 4-week follow-up.
|
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):
|
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
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.
|
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. |
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data (IPD) will be shared, including item-level questionnaire responses and derived summary scores collected at each study time point (e.g., symptom attribution scores, functional interference scores, and adherence scores), as well as basic demographic variables necessary to reproduce the primary analyses.
Data that could directly or indirectly identify individual participants (e.g., names, contact details, dates of birth) will not be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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