Systematic Light Exposure for Pediatric Brain Tumor Survivors
This study is looking at whether using bright light exposure can help children and teenagers, aged 10 to 18, who have been treated for a brain tumor. Many survivors experience tiredness (fatigue) and problems with thinking (cognitive symptoms) like slow processing or trouble paying attention. This study will compare daily use of special bright light glasses (Luminette Version 3) to dim light glasses over 6 weeks. Researchers will check if the bright light helps with fatigue, sleep, and mood. This is a small pilot study with 40 participants to see if this approach is promising for future, larger studies. To join, you must have been treated for a brain tumor at Texas Children's Hospital and meet other specific criteria.
- Study design
- This is an interventional study with 40 planned participants. Participants will be randomly assigned to either the bright light group or the dim light group.
- What's involved
- You would use special light glasses for up to 30 minutes each weekday for 6 weeks. You would also complete cognitive assessments and questionnaires at the start, Week 4, Week 6, and Week 8.
- Compensation
- Not stated in the trial record.
- Follow-up
- Assessments will be completed up to 2 weeks after the intervention ends (Week 8).
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Systematic Light Exposure in Pediatric Brain Tumor Survivors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kimberly P Raghubar, PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
- Heather M Conklin, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percent of approached participants who consent to study participationOnce, prior to enrollment
The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 70%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
- Percent of sessions completed during all 6 weeks of bright or dim light exposureAt completion of bright or dim light exposure (Week 6)
The rates of light intervention adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 77% of sessions completed on average. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
- Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.Once, at completion of intervention (Week 6)
The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.