Assessment of Sleep Complaints in Brain Tumor Survivors


N/A
8 Years
18 Years
Open (Enrolling)
Both
Brain Tumors

Thank you

Trial Information

Assessment of Sleep Complaints in Brain Tumor Survivors


This non-therapeutic single arm study will characterize the prevalence and types of sleep
complaints of pediatric brain tumor survivors. Brain tumor survivors ages 8 to 18 years who
are at least 5 years post diagnosis and 2 years post active therapy and their
parents/guardians will be approached to participate during clinic visits. If the patient and
guardian agree to participate, they will be administered three questionnaires in the clinic
during the patient's visit. From the medical record, the following variables will be
utilized to characterize the subjects and estimate which groups are at greatest risk of
sleep disturbances:

- Specific brain tumor diagnosis

- Location of tumor (cerebral hemispheres, parasellar region, posterior fossa, or spine)

- Age at diagnosis

- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation
only)


Inclusion Criteria:



- Age ≥8 to ≤ 18 years of age

- Brain tumor survivor

- ≥5 years post diagnosis

- ≥2 years post active cancer-directed therapy or observation only

- Parents speak and read English fluently

- Potential participant reads English fluently

- Potential participant/guardian willing to sign consent

Exclusion Criteria:

*Survivor of any cancer other than a brain tumor.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Sleep disturbance in a cohort of pediatric brain tumor survivors.

Outcome Description:

Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Valerie Crabtree, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

PBTSLP

NCT ID:

NCT01102998

Start Date:

April 2010

Completion Date:

April 2013

Related Keywords:

  • Brain Tumors
  • Sleep complaints
  • Brain Tumor Survivors
  • Brain Neoplasms

Name

Location
St . Jude Children's Research Hospital Memphis, Tennessee  38105