Characterizing Sleep Among Long-term Survivors of Childhood Cancer

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

ALL, Adult, CNS Tumor, Solid Tumor

Being tested

Neurocognitive (Thinking) Testing, CNS Vital Signs (Thinking) Testing, Health Questionnaires, Sleep Surveys & Sleep Diary, Echocardiography/EKG, Pulmonary Function

Medical subject headings

Precursor Cell Lymphoblastic Leukemia-Lymphoma, Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Neurocognitive (Thinking) TestingOther

  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) TestingDiagnostic 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 DiaryOther

  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/EKGDiagnostic 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 FunctionDiagnostic test

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

• Remote PolysomnographyDevice

  Also called Sleep Profiler PSG2-Overnight Sleep Study

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

• Physical FunctionDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline

2. 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.

   Measured: Baseline

3. 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).

   Measured: Baseline

4. 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.

   Measured: Baseline

5. 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.

   Measured: Baseline

6. 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."

   Measured: Baseline for 2 nights

7. 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

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Jul 2022
2. Study start17 Apr 2023
3. Primary completion29 Apr 2026
4. Study completionJan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for ALL, AdultStudies of the same condition, open and under way.
• More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.