Systematic Light Exposure in Pediatric Brain Tumor Survivors

NCT05340881 | Recruiting DMC

• 2 other identifiers: H-50648R21NR019892
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 2.To estimate the effect size of change in fatigue associated with bright light exposure.
3. 3.To estimate the effect size of change in cognitive efficiency associated with bright light exposure.

Conditions

Brain Tumor

Keywords

Pediatric Oncology; Fatigue; Cognitive Late Effects; Light Exposure; Sleep; Mood; Brain Tumor

Outcome Measures

Primary Outcomes (3)

• Percent of approached participants who consent to study participation

  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.

  Once, prior to enrollment

• Percent of sessions completed during all 6 weeks of bright or dim light exposure

  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.

  At completion of bright or dim light exposure (Week 6)

• Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.

  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.

  Once, at completion of intervention (Week 6)

Secondary Outcomes (4)

• Change in fatigue outcome

  Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)

• Change in fatigue outcome

  Baseline (prior to start of intervention) compared to Week 6 (end of intervention)

• Change in neurobehavioral outcome

  Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)

• Change in neurobehavioral outcome

  Baseline (prior to start of intervention) compared to Week 6 (end of intervention)

Study Arms (2)

Bright Light Exposure

ACTIVE COMPARATOR

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.

Behavioral: Bright Light Exposure; Other: Cognitive Assessment

Dim Light Exposure

PLACEBO COMPARATOR

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.

Behavioral: Dim Light Exposure; Other: Cognitive Assessment

Interventions

Bright Light Exposure BEHAVIORAL

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.

Bright Light Exposure

Dim Light Exposure BEHAVIORAL

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.

Also known as: Placebo

Dim Light Exposure

Cognitive Assessment OTHER

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).

Also known as: Cognitive tests and questionnaires

Bright Light Exposure; Dim Light Exposure

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Nursing Research (NINR): collaborator
• St. Jude Children's Research Hospital: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Fatigue

Interventions

Mental Status and Dementia Tests; Neuropsychological Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kimberly P Raghubar, PhD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

• Heather M Conklin, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly P Raghubar, PhD

CONTACT

832-822-3713; kpraghub@texaschildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double-blind, placebo-controlled trial design

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 22, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication.
• Access Criteria: Upon request to PI

Locations

US (1)