RecruitingNot ApplicableNCT05340881

Systematic Light Exposure in Pediatric Brain Tumor Survivors

Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors


Sponsor

Baylor College of Medicine

Enrollment

40 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action. 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.


Eligibility

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured light therapy program can reduce fatigue and improve sleep in children and teenagers who survived brain tumors and are experiencing ongoing tiredness after treatment. **You may be eligible if...** - You are between 10 and 18 years old and a brain tumor survivor treated at Texas Children's Hospital - You were treated with surgery alone or surgery plus proton beam radiation - It has been at least 1 year since your diagnosis - You have mild to moderate fatigue - You have an IQ above 70 and can do computer-based tasks - You speak English - Your long-term survivorship provider has approved participation **You may NOT be eligible if...** - You had high-grade glioma, brain stem glioma, or atypical teratoid rhabdoid tumors - You are not enrolled in the associated longitudinal neurocognitive studies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBright 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.

BEHAVIORALDim 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.

OTHERCognitive 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).


Locations(1)

Texas Children's Hospital

Houston, Texas, United States

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NCT05340881


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