Characterizing Sleep Among Long-term Survivors of Childhood Cancer
St. Jude Children's Research Hospital
120 participants
Apr 17, 2023
OBSERVATIONAL
Conditions
Summary
The patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors. 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.
Eligibility
Inclusion Criteria6
- Participant in SJLIFE and \> 5 years from diagnosis.
- \>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 Criteria7
- Estimated intelligence score \<80.
- 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.
Interventions
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.
Attention: Continuous Performance Task 5 mins Processing Speed: Symbol Digit Test 4 mins Executive Function: Shifting Attention 3 min and Stroop Test 5 mins
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.
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
PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).
The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
This is a test of how your heart and lungs respond to exercise.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05480904