Brain TumorsNCT01102998
Assessment of Sleep Complaints in Brain Tumor Survivors
An observational study of Brain Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Brain Tumors
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Survivor of any cancer other than a brain tumor.
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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:
Read more
- 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
Read the 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
- Obesity status
- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)
- Conditions
- Brain Tumors
- Keywords
- Sleep complaints, Brain Tumor Survivors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Crabtree, Ph.D, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102998
- Sponsor's protocol ID
- PBTSLP
- Status last verified
- Nov 2013
- First submitted
- 12 Apr 2010
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Complaints in Brain Tumor Survivors
- ClinicalTrials.gov ID
- NCT01102998
- Acronym / sponsor ID
- PBTSLP
- Conditions
- Brain Tumors
- Keywords
- Sleep complaints, Brain Tumor Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Obesity status
- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Survivor of any cancer other than a brain tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep disturbance in a cohort of pediatric brain tumor survivors.
Time frame: 2 years
* 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- St. Jude Children's Research HospitalLink provided by the sponsor.
Related trials for Brain Tumors
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Crabtree, Ph.D principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance in a cohort of pediatric brain tumor survivors. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.