Clinical trial NCT05340881: Systematic Light Exposure in Pediatric Brain Tumor Survivors
Official title: Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: Pediatric Oncology
Fatigue
Cognitive Late Effects
Light Exposure
Sleep
Mood
Brain Tumor
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: St. Jude Children's Research Hospital
First posted: 2022-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled trial design
Primary purpose: SUPPORTIVE_CARE

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:

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.

Detailed 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.

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
* 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

Primary outcomes:
measure: Percent of approached participants who consent to study participation
timeFrame: Once, prior to enrollment
measure: Percent of sessions completed during all 6 weeks of bright or dim light exposure
timeFrame: At completion of bright or dim light exposure (Week 6)
measure: Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
timeFrame: Once, at completion of intervention (Week 6)
Secondary outcomes:
measure: Change in fatigue outcome
timeFrame: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
measure: Change in fatigue outcome
timeFrame: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
measure: Change in neurobehavioral outcome
timeFrame: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
measure: Change in neurobehavioral outcome
timeFrame: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine - Texas Children's Hospital
name: Kimberly P Raghubar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Heather M Conklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: