Characterizing Sleep Among Long-term Survivors of Childhood Cancer
NCT ID: NCT05480904
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-04-17
2027-01-31
Brief Summary
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Primary Objective
The primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood ALL, CNS tumors, and non- CNS solid tumors.
Exploratory Objective
The exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in SJLIFE.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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On campus
SJLIFE Study Campus Visit
Neurocognitive (Thinking) Testing
Intelligence: WASI-II 20 min; Sustained Attention:
Conners Continuous Performance Test 3rd ED. 15 min; Memory: California Verbal Learning Test 2nd Ed. 20 min; Visual Selective Reminding 7 min; Processing Speed:Coding/Digit Symbol 3 min; Grooved Pegboard 5 min; Executive Function: Trail Making Test 5 min; Verbal Fluency Test 3 min; Digit Span 5 min; Visuospatial: Rey Complex Figure 10 min; Functional Behavior: CCSS Neurocognitive Questionnaire 5 min.
Health Questionnaires, Sleep Surveys & Sleep Diary
The participant will be asked to complete the sleep surveys and sleep diary, FACIT fatigue, and CSALTS Pain Survey These questionnaires will take about 29 minutes to complete. The sleep diary is completed at the time the participant wears the sleep device.
Echocardiography/EKG
All echocardiograms will be performed using a General Electric VIVID-7. The LV volume, mass and EF will be calculated using the recommendations of the American Society of Echocardiography
Pulmonary Function
PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).
Remote Polysomnography
The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
Physical Function
This is a test of how your heart and lungs respond to exercise.
Remote
SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors
CNS Vital Signs (Thinking) Testing
Attention: Continuous Performance Task 5 mins Processing Speed: Symbol Digit Test 4 mins Executive Function: Shifting Attention 3 min and Stroop Test 5 mins
Health Questionnaires, Sleep Surveys & Sleep Diary
The participant will be asked to complete the sleep surveys and sleep diary, FACIT fatigue, and CSALTS Pain Survey These questionnaires will take about 29 minutes to complete. The sleep diary is completed at the time the participant wears the sleep device.
Remote Polysomnography
The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
Interventions
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Neurocognitive (Thinking) Testing
Intelligence: WASI-II 20 min; Sustained Attention:
Conners Continuous Performance Test 3rd ED. 15 min; Memory: California Verbal Learning Test 2nd Ed. 20 min; Visual Selective Reminding 7 min; Processing Speed:Coding/Digit Symbol 3 min; Grooved Pegboard 5 min; Executive Function: Trail Making Test 5 min; Verbal Fluency Test 3 min; Digit Span 5 min; Visuospatial: Rey Complex Figure 10 min; Functional Behavior: CCSS Neurocognitive Questionnaire 5 min.
CNS Vital Signs (Thinking) Testing
Attention: Continuous Performance Task 5 mins Processing Speed: Symbol Digit Test 4 mins Executive Function: Shifting Attention 3 min and Stroop Test 5 mins
Health Questionnaires, Sleep Surveys & Sleep Diary
The participant will be asked to complete the sleep surveys and sleep diary, FACIT fatigue, and CSALTS Pain Survey These questionnaires will take about 29 minutes to complete. The sleep diary is completed at the time the participant wears the sleep device.
Echocardiography/EKG
All echocardiograms will be performed using a General Electric VIVID-7. The LV volume, mass and EF will be calculated using the recommendations of the American Society of Echocardiography
Pulmonary Function
PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).
Remote Polysomnography
The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
Physical Function
This is a test of how your heart and lungs respond to exercise.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>18 years of age at time of enrollment.
* Diagnosed with ALL (treated with CRT or chemotherapy only) or CNS tumors (posterior fossa tumors or supratentorial tumors) or non-CNS solid tumors (with abdominal or chest radiation or bilateral retinoblastoma survivors).
* Participant was less than 21 years of age at time of diagnosis.
* Speaks and understands English (polysomnography device speaks to patients only in English).
* Remote participant must have Wi-Fi access
Exclusion Criteria
* Currently prescribed an intervention for a sleep disorder.
* Survivor of craniopharyngioma.
* Survivor of Hodgkin Lymphoma.
* Relapsed or treated with hematopoietic stem cell therapy.
* Brain injury unrelated to cancer diagnosis or therapy.
* Pulmonary injury unrelated to cancer diagnosis or therapy.
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Kevin Krull, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2022-08555
Identifier Type: REGISTRY
Identifier Source: secondary_id
CSALTS
Identifier Type: -
Identifier Source: org_study_id
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