Characterizing Sleep Among Long-term Survivors of Childhood Cancer

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.

Conditions

• ALL, Adult
• CNS Tumor
• Solid Tumor

Interventions

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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Kevin Krull, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2026-07-31

Completion

2027-01-31

Countries

• United States

Study Locations