Assessment of Sleep Complaints in Brain Tumor Survivors
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Purpose
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
| Condition |
|---|
|
Brain Tumors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Sleep Complaints in Brain Tumor Survivors |
- Sleep disturbance in a cohort of pediatric brain tumor survivors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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.
| Enrollment: | 153 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
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)
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| United States, Tennessee | |
| St . Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | Valerie Crabtree, Ph.D | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01102998 History of Changes |
| Other Study ID Numbers: | PBTSLP |
| Study First Received: | April 12, 2010 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
|
Sleep complaints Brain Tumor Survivors |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013