Systematic Light Exposure in Pediatric Brain Tumor Survivors

Brain Tumor Clinical Trial

— SLEPBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340881
• Other study ID #: H-50648
• Secondary ID: R21NR019892
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: Kimberly P Raghubar, PhD
• Phone: 832-822-3713
• Email: kpraghub[@]texaschildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants will be randomized to take part in one of two groups:

1. 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.

2. 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), saliva 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

• 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

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Behavioral:
• Bright Light Exposure
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.
• Dim Light Exposure
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.

Other:
• Cognitive Assessment
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).

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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.	Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Secondary	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.	Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Secondary	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.	Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Secondary	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.	Baseline (prior to start of intervention) compared to Week 6 (end of intervention)