Assessment of Sleep Complaints in Brain Tumor Survivors

NCT01102998 | Completed

• 1 other identifier: PBTSLP
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints. The study focuses on the following objectives:

• To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.
• 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. The Study focuses on the following secondary objectives:
• To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.
• Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors
• Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration
• Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors

Conditions

Brain Tumors

Keywords

Sleep complaints; Brain Tumor Survivors

Outcome Measures

Primary Outcomes (1)

• Sleep disturbance in a cohort of pediatric brain tumor survivors.

  * 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.

  2 years

Study Arms (1)

Brain Tumor Survivors

Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and at least 2 years post active therapy or observation and their parents/guardians will be approached to participate during clinic visits.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 8 to 18 years of age who are patients at St Jude Children's Research Hospital and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor were targeted to assess the prevalence of sleep complaints.

You may qualify if:

• 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

You may not qualify if:

• Survivor of any cancer other than a brain tumor.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Valerie Crabtree, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

US (1)