Characterizing Sleep Among Long-term Survivors of Childhood Cancer

NCT05480904 | Recruiting

• 2 other identifiers: CSALTSNCI-2022-08555
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Insomnia Severity Index (ISI)

  ISI is a seven-item questionnaire that looks at symptoms of clinical insomnia. The ISI assesses insomnia symptoms over the past 14 days and has demonstrated good reliability and validity. The total ISI score ranges from 0 to 28, with scores \< 8 indicating no significant insomnia.

  Baseline

• CSALTS Sleep Survey

  CSALTS Sleep Survey incorporating Epworth Sleepiness Scale (EPS) and Pittsburg Sleep Quality Index (PSQI) The CSALTS Sleep Survey assesses sleep quality, patterns, and daytime sleepiness. It incorporates 19 questions from the PSQI and 8 questions of the ESS. The PSQI and ESS total scores will be reported.

  Baseline

• Morningness-Eveningness Questionnaire (MEQ)

  The MEQ is a 19-question measure that assesses the degree to which respondents are active and alert at certain times of the day. Each item is rated using a Likert-type scale with lower scales reflecting a more evening-type characterization of alertness. Global scores range from 16 to 86 and these values are used to define 'definitely morning type' (70-86), 'moderately morning type' (59-69), 'neither type' (42-58), 'moderately evening type' (31-41), and 'definitely evening type' (16-30).

  Baseline

• Circadian Type Inventory (CTI)

  CTI is an 11-item questionnaire that looks at rigidity/flexibility of sleeping habits and ability/inability to overcome drowsiness (i.e., circadian rhythm disorders). Respondents use a 5-item, Likert-type scale to answer questions regarding their sleep habits and preferences. Scales range from 1 ("almost never") to 5 ("almost always"). Higher scores on the rigidity subscales indicate a greater flexibility in circadian rhythm, while lower scores on the overcoming-drowsiness subscale indicate a greater ability to manage on less sleep.

  Baseline

• Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)

  fatigue scale is a short 13-item tool that provides a single measure of an individual's level of fatigue during a usual day.

  Baseline

• CSALTS Pain Survey

  The 7-item pain survey will include pain interference questions from the SJLIFE Behavioral Survey and one pain intensity question. The six items that measures amount of pain interference in daily activities in last 7 days is measured from "not at all" to "very much." The pain intensity question is measured 1-10 with 10 "worst imaginable pain."

  Baseline for 2 nights

• Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT)

  The Sleep Profiler PSG2 measures brain waves during sleep, blood oxygen levels, heart rate, and breathing and will measure different patterns of sleep stages. Two nights of data collection will be requested though one night will be sufficient if the participant sleeps at least 4 hours. The apnea hypopnea index and sleep efficiency scores will be reported. The WatchPAT device assesses sleep timing, sleep staging, and sleep apnea events via a device worn on the wrist that measures limb movement, peripheral arterial tone and connects to an EKG electrode. Two nights of data collection will be requested though one night will be sufficient if the participant sleeps at least 4 hours. The apnea hypopnea index and sleep efficiency scores will be reported

  Baseline

Secondary Outcomes (5)

• Sustained Attention -Conners Continuous Performance Test 3rd Ed or CNS-VS CPT.

  Baseline

• Memory-California Verbal Learning Test 2nd Ed.

  Baseline

• Executive Functions -Trail Making Test or CNS-VS Shifting Attention Test

  Baseline

• Executive Functions- Verbal Fluency Test Controlled Oral Word Association (COWA) or CNS-VS Stroop Test

  Baseline

• Executive Functions -Digit Span Backward

  Baseline

Other Outcomes (5)

• Intelligence

  Baseline

• Processing Speed - Coding/Digit Symbol or CNS-VS Symbol Digit Test

  Baseline

• Processing Speed-Grooved Pegboard

  Baseline

Study Arms (2)

On campus

SJLIFE Study Campus Visit

Other: Neurocognitive (Thinking) Testing; Other: Health Questionnaires, Sleep Surveys & Sleep Diary; Diagnostic Test: Echocardiography/EKG; Diagnostic Test: Pulmonary Function; Device: Remote Polysomnography; Diagnostic Test: Physical Function

Remote

SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors

Diagnostic Test: CNS Vital Signs (Thinking) Testing; Other: Health Questionnaires, Sleep Surveys & Sleep Diary; Device: Remote Polysomnography

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.

On campus

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

Remote

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.

On campus; Remote

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

On campus

Pulmonary Function DIAGNOSTIC_TEST

PFTs will include spirometry, lung volume measurements by body plethysmography and single breath carbon monoxide-diffusion capacity (DLCO).

On campus

Remote Polysomnography DEVICE

The Sleep Profiler PSG2/WatchPat device will be used to assess nighttime sleep disorders.

Also known as: Sleep Profiler PSG2-Overnight Sleep Study

On campus; Remote

Physical Function DIAGNOSTIC_TEST

This is a test of how your heart and lungs respond to exercise.

On campus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Central Nervous System Neoplasms

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kevin Krull, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Krull, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 29, 2022
• Study Start: April 17, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)