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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Kimberly P Raghubar, PhD
kpraghub@texaschildrens.org
832-822-3713
Time Frame
Start Date: 2022-10-14
Estimated Completion Date: 2026-07
Participants
Target number of participants: 40
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov