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Customized Video for Anxiety Reduction in Brain Tumor Radiation Treatment

This study is testing if a personalized video can help reduce anxiety for patients with certain brain tumors (glioblastoma, WHO Grade II or III glioma) and their caregivers during and after radiation treatment. The video, called a Neuro-Imaging Referenced Symptom (NIRS) video, explains symptoms and side effects based on your specific tumor. You would either receive standard information or standard information plus this NIRS video. Researchers will measure changes in your anxiety levels using a questionnaire at different times up to one month after radiation therapy. This study aims to see if this video can improve your quality of life by lowering anxiety.

Study design
This is an interventional study planning to enroll 117 participants. Participants and their caregivers will be randomly assigned to one of two groups.
What's involved
You would complete questionnaires in English and potentially an optional survey. You would also watch the NIRS video if assigned to that group.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety levels will be measured from the start of the study up to one month after radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04479696

Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors

Recruiting
NAAges 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~117 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Educational InterventionQuestionnaire AdministrationSurvey AdministrationVideo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)
Measured over From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)

Conditions

Glioblastoma
WHO Grade II Glioma
WHO Grade III Glioma

Explore related trials

GlioblastomaGlioma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Caroline Chung · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Caroline Chung
[email protected]
713-745-5422
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PATIENT ELIGIBILITY CRITERIA: Adult patients with newly diagnosed glioma (World Health Organization \[WHO\] grade 2-4) who are planned for a 6-week course of radiotherapy after surgery
PATIENT ELIGIBILITY CRITERIA: Able to complete questionnaires in English
PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the start of radiotherapy
CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (\>= 18 years) who is accompanying an eligible patient consented to the study
CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is consented for participation on the study
CAREGIVER ELIGIBILITY CRITERIA: Able and willing to complete questionnaires in English

Exclusion

PATIENT ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation
PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status \[KPS\] \< 60) that prevent the ability to complete the questionnaires
CAREGIVER ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation

What this trial measures

  • Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)

    Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain \[FACT- Br\]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.