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

Inclusion Criteria11

  • Diagnosed and treated for a brain tumor at Texas Children's Hospital
  • 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 Criteria5

  • Diagnosis and/or treatment for secondary malignancy in the past 12 months
  • 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

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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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