RECRUITING

Systematic Light Exposure in Pediatric Brain Tumor Survivors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-14
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05340881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed and treated for a brain tumor at Texas Children's Hospital
  2. * Treated with either surgery only or surgery and proton beam radiation therapy
  3. * Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates
  4. * 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
  5. * Ages 10-18 years
  6. * At least 1 year post-diagnosis
  7. * Endorsed mild to moderate symptoms of fatigue on the PROMIS
  8. * Approval from Long-Term Survivorship provider
  9. * Adequate vision for computerized tasks
  10. * English-speaking
  11. * Intelligence Quotient (IQ) above 70
  1. * Diagnosis and/or treatment for secondary malignancy in the past 12 months
  2. * Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention
  3. * Presence of photophobia or other eye diseases, seizures, and/or migraines
  4. * Use of photosensitizing medications
  5. * Current or previous use of light therapy

Contacts and Locations

Study Contact

Kimberly P Raghubar, PhD
CONTACT
832-822-3713
kpraghub@texaschildrens.org

Principal Investigator

Kimberly P Raghubar, PhD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine - Texas Children's Hospital
Heather M Conklin, PhD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Kimberly P Raghubar, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine - Texas Children's Hospital
  • Heather M Conklin, PhD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-14
Study Completion Date2025-03

Study Record Updates

Study Start Date2022-10-14
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Brain Tumor