Systematic Light Exposure in Pediatric Brain Tumor Survivors

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.

Conditions

• Brain Tumor

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

OTHER

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).

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• St. Jude Children's Research Hospital

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Kimberly P Raghubar, PhD · Baylor College of Medicine - Texas Children's Hospital

• Heather M Conklin, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-14

Primary Completion

2026-06-30

Completion

2026-07-31

Countries

• United States

Study Locations