Bright Light Exposure for Neoplasms, Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Children's Hospital, Houston, TX
Neoplasms, Brain+1 More
Bright Light Exposure - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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: 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: To estimate the effect size of change in fatigue associated with bright light exposure. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.

Eligible Conditions

  • Neoplasms, Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neoplasms, Brain

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Once, at completion of intervention (Week 6)

Week 6
Percent of sessions completed during all 6 weeks of bright or dim light exposure
Week 6
Change in fatigue outcome
Change in neurobehavioral outcome
Week 6
Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
Once, prior to enrollment
Percent of approached participants who consent to study participation

Trial Safety

Safety Progress

1 of 3

Other trials for Neoplasms, Brain

Trial Design

2 Treatment Groups

Bright Light Exposure
1 of 2
Dim Light Exposure
1 of 2
Active Control
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Bright Light Exposure · Has Placebo Group · N/A

Bright Light ExposureActiveComparator Group · 2 Interventions: Bright Light Exposure, Cognitive Assessment · Intervention Types: Behavioral, Other
Dim Light ExposurePlaceboComparator Group · 2 Interventions: Dim Light Exposure, Cognitive Assessment · Intervention Types: Behavioral, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: once, at completion of intervention (week 6)
Closest Location: Texas Children's Hospital · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2005First Recorded Clinical Trial
4 TrialsResearching Neoplasms, Brain
311 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
514 Previous Clinical Trials
284,490 Total Patients Enrolled
St. Jude Children's Research HospitalOTHER
390 Previous Clinical Trials
5,294,587 Total Patients Enrolled
17 Trials studying Neoplasms, Brain
3,189 Patients Enrolled for Neoplasms, Brain
Baylor College of MedicineLead Sponsor
910 Previous Clinical Trials
5,981,726 Total Patients Enrolled
1 Trials studying Neoplasms, Brain
119 Patients Enrolled for Neoplasms, Brain
Kimberly P Raghubar, PhDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital
Heather M Conklin, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with a brain tumor and have been treated for it at Texas Children's Hospital.
You have had a diagnosis of cancer for at least 3 years.
Endorsed mild to moderate symptoms of fatigue on the PROMIS.
You have adequate vision for computerized tasks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.