NCT07405320

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

November 18, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

MindsetDigital InterventionRadioiodine

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    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

    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.

Study Arms (2)

Intervention Video

EXPERIMENTAL

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.

Behavioral: Intervention Video

Control Video

ACTIVE COMPARATOR

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.

Behavioral: Control Video

Interventions

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.

Intervention Video
Control VideoBEHAVIORAL

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.

Control Video

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid NeoplasmsHyperthyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To control for expectation effects both groups will be told that we are testing different videos to assist patients with the radioiodine treatment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a two-arm parallel 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. Outcomes will then be compared between the two groups in terms of side effects, disability and understanding of treatment precautions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 12, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

July 6, 2026

Study Completion (Estimated)

July 6, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The start date will be after publication of the primary results or completion of the thesis, whichever occurs first. IPD will be available upon reasonable request for up to 5 years following study completion.
Access Criteria
De-identified IPD and supporting information will be available to qualified researchers upon reasonable request. Requests must include a brief proposal outlining the intended use of the data and will be reviewed by the study investigators. Approved requestors will be granted access to de-identified datasets and supporting documentation via secure data transfer. Data sharing will be conducted in accordance with institutional ethics approval and data governance requirements.