NCT05480904

Characterizing Sleep Among Long-term Survivors of Childhood Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A cross-sectional pilot study that will enroll participants for on-campus or remote study activities. The investigators anticipate a targeted evaluable accrual of 120, 40 within each of the three groups identified above. The plan is to employ remote polysomnography and surveys to assess patterns of sleep disorders. These assessments could be done in the homes of survivors or during campus visits.

Conditions

• ALL, Adult
• CNS Tumor
• Solid Tumor

Interventions

Type	Name	Description
OTHER	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.
DIAGNOSTIC_TEST	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
OTHER	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.
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	Pulmonary Function	PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).
DEVICE	Remote Polysomnography	The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.
DIAGNOSTIC_TEST	Physical Function	This is a test of how your heart and lungs respond to exercise.

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2022-07-29
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States