search
Back to results

Systematic Light Exposure in Pediatric Brain Tumor Survivors (SLEPBT)

Primary Purpose

Brain Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Light Exposure
Dim Light Exposure
Cognitive Assessment
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring Pediatric Oncology, Fatigue, Cognitive Late Effects, Light Exposure, Sleep, Mood, Brain Tumor

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Enrolled on/in existing longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-50648)
  • Ages 10-18 years
  • At least 3 years 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Texas Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bright Light Exposure

Dim Light Exposure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change in fatigue outcome
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Change in fatigue outcome
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 6 (end of systematic light exposure), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.
Change in neurobehavioral outcome
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Change in neurobehavioral outcome
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 6 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.

Full Information

First Posted
March 23, 2022
Last Updated
May 19, 2023
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05340881
Brief Title
Systematic Light Exposure in Pediatric Brain Tumor Survivors
Acronym
SLEPBT
Official Title
Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.
Detailed Description
Participants will be randomized to take part in one of two groups: The Bright Light Group will be exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes each day from Monday to Friday for a total of 6 weeks. Duration of light exposure will be gradually increased over the first few days until the target of 30 minutes is reached on Day 5. Light duration is for 10 mins on Days 1 & 2, 20 mins on Days 3 & 4, and finally, 30 mins on Day 5. The Dim Light Group will be exposed to dim light (equivalent intensity of <25 lux) for a maximum duration of 30 minutes. Dim light will be given in the same manner and frequency as described for the Bright Light group. Participants will undergo the same evaluations and monitoring throughout the intervention and post-intervention follow-up. All participants will receive a pair of light glasses, with a phone app to track usage, and be fitted with an actigraph following consent to participate. Assessments will be completed at baseline (prior to intervention), with additional assessments at Week 4 (of intervention), Week 6 (end of intervention), and 2-weeks post-intervention (Week 8). Participants and their caregivers will complete questionnaires assessing fatigue, sleep, and mood. Psychological testing to measure attention, working memory, executive control, and processing speed will be completed using a computerized, online battery at each time point and in person at baseline and end of intervention. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history. At baseline and end of intervention (Week 6), blood work will be collected. For each day of the intervention, participants will share their usage data and complete a daily sleep diary that includes time spent in bed, sleep/wake times, estimated amount of natural sunlight exposure, and medication use. A research coordinator will contact families on Days 2 and 5 and weekly thereafter for the duration of the intervention to identify possible light-related side effects and to check on compliance with light exposure (both frequency and duration). A remote app will be installed on the participant's or caregiver's cell phone to share light usage, which is tracked automatically once the device is turned on. At end of intervention (Week 6), participants and their caregivers will be asked to complete a short acceptability questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Pediatric Oncology, Fatigue, Cognitive Late Effects, Light Exposure, Sleep, Mood, Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled trial design
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright Light Exposure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dim Light Exposure
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bright Light Exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dim Light Exposure
Other Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Assessment
Other Intervention Name(s)
Cognitive tests and questionnaires
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percent of approached participants who consent to study participation
Description
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.
Time Frame
Once, prior to enrollment
Title
Percent of sessions completed during all 6 weeks of bright or dim light exposure
Description
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.
Time Frame
At completion of bright or dim light exposure (Week 6)
Title
Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
Description
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.
Time Frame
Once, at completion of intervention (Week 6)
Secondary Outcome Measure Information:
Title
Change in fatigue outcome
Description
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Time Frame
Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Title
Change in fatigue outcome
Description
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 6 (end of systematic light exposure), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.
Time Frame
Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Title
Change in neurobehavioral outcome
Description
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Time Frame
Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Title
Change in neurobehavioral outcome
Description
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 6 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.
Time Frame
Baseline (prior to start of intervention) compared to Week 6 (end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Enrolled on/in existing longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-50648) Ages 10-18 years At least 3 years 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly P Raghubar, PhD
Phone
832-822-3713
Email
kpraghub@texaschildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly P Raghubar, PhD
Organizational Affiliation
Baylor College of Medicine - Texas Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather M Conklin, PhD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly P Raghubar, PhD
Phone
832-822-3713
Email
kpraghub@texaschildrens.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share de-identified data for all IPD that underlie results in a publication upon reasonable request.
IPD Sharing Time Frame
6 months after publication.
IPD Sharing Access Criteria
Upon request to PI

Learn more about this trial

Systematic Light Exposure in Pediatric Brain Tumor Survivors

We'll reach out to this number within 24 hrs