Systematic Light Exposure in Pediatric Brain Tumor Survivors
NCT ID: NCT05340881
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-10-14
2026-07-31
Brief Summary
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PRIMARY OBJECTIVE:
1. To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability.
SECONDARY OBJECTIVES:
2. To estimate the effect size of change in fatigue associated with bright light exposure.
3. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.
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Detailed Description
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1. The Bright Light Group will be exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes each day from Monday to Friday for a total of 6 weeks. Duration of light exposure will be gradually increased over the first few days until the target of 30 minutes is reached on Day 5. Light duration is for 10 mins on Days 1 \& 2, 20 mins on Days 3 \& 4, and finally, 30 mins on Day 5.
2. The Dim Light Group will be exposed to dim light (equivalent intensity of \<25 lux) for a maximum duration of 30 minutes. Dim light will be given in the same manner and frequency as described for the Bright Light group.
Participants will undergo the same evaluations and monitoring throughout the intervention and post-intervention follow-up. All participants will receive a pair of light glasses, with a phone app to track usage, and be fitted with an actigraph following consent to participate. Assessments will be completed at baseline (prior to intervention), with additional assessments at Week 4 (of intervention), Week 6 (end of intervention), and 2-weeks post-intervention (Week 8). Participants and their caregivers will complete questionnaires assessing fatigue, sleep, and mood. Psychological testing to measure attention, working memory, executive control, and processing speed will be completed using a computerized, online battery at each time point and in person at baseline and end of intervention. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history.
At baseline and end of intervention (Week 6), saliva will be collected. For each day of the intervention, participants will share their usage data and complete a daily sleep diary that includes time spent in bed, sleep/wake times, estimated amount of natural sunlight exposure, and medication use. A research coordinator will contact families on Days 2 and 5 and weekly thereafter for the duration of the intervention to identify possible light-related side effects and to check on compliance with light exposure (both frequency and duration). A remote app will be installed on the participant's or caregiver's cell phone to share light usage, which is tracked automatically once the device is turned on. At end of intervention (Week 6), participants and their caregivers will be asked to complete a short acceptability questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Bright Light Exposure
Participants are exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work.
Bright Light Exposure
Research coordinator will follow-up with participant on Days 2 \& 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued.
Cognitive Assessment
Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo).
Dim Light Exposure
Participants are exposed to exposed to dim light (equivalent intensity of \<25 lux) using light glasses (Luminette) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work.
Dim Light Exposure
A placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses.
Cognitive Assessment
Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo).
Interventions
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Bright Light Exposure
Research coordinator will follow-up with participant on Days 2 \& 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued.
Dim Light Exposure
A placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses.
Cognitive Assessment
Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with either surgery only or surgery and proton beam radiation therapy
* Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates
* Currently or previously enrolled in longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-49380, H-26785, H-41705
* Ages 10-18 years
* At least 1 year post-diagnosis
* Endorsed mild to moderate symptoms of fatigue on the PROMIS
* Approval from Long-Term Survivorship provider
* Adequate vision for computerized tasks
* English-speaking
* Intelligence Quotient (IQ) above 70
Exclusion Criteria
* Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention
* Presence of photophobia or other eye diseases, seizures, and/or migraines
* Use of photosensitizing medications
* Current or previous use of light therapy
10 Years
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
St. Jude Children's Research Hospital
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Kimberly Raghubar
Assistant Professor
Principal Investigators
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Kimberly P Raghubar, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine - Texas Children's Hospital
Heather M Conklin, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Texas Children's Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-50648
Identifier Type: -
Identifier Source: org_study_id
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