Characterizing Sleep Among Long-term Survivors of Childhood Cancer

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05480904
Status
Active Not Recruiting

Conditions

  • ALL, Adult
  • CNS Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 17, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
199 participants (estimated)

Arms

  • Arm: On campus
    SJLIFE Study Campus Visit
  • Arm: Remote
    SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

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