Clinical trial NCT05480904: Characterizing Sleep Among Long-term Survivors of Childhood Cancer
Official title: Characterizing Sleep Among Long-term Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALL, Adult
CNS Tumor
Solid Tumor
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: CSALTS Sleep Survey
timeFrame: Baseline
measure: Morningness-Eveningness Questionnaire (MEQ)
timeFrame: Baseline
measure: Circadian Type Inventory (CTI)
timeFrame: Baseline
measure: Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
timeFrame: Baseline
measure: CSALTS Pain Survey
timeFrame: Baseline for 2 nights
measure: Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT)
timeFrame: Baseline
Secondary outcomes:
measure: Sustained Attention -Conners Continuous Performance Test 3rd Ed or CNS-VS CPT.
timeFrame: Baseline
measure: Memory-California Verbal Learning Test 2nd Ed.
timeFrame: Baseline
measure: Executive Functions -Trail Making Test or CNS-VS Shifting Attention Test
timeFrame: Baseline
measure: Executive Functions- Verbal Fluency Test Controlled Oral Word Association (COWA) or CNS-VS Stroop Test
timeFrame: Baseline
measure: Executive Functions -Digit Span Backward
timeFrame: Baseline
Other outcomes:
measure: Intelligence
timeFrame: Baseline
measure: Processing Speed - Coding/Digit Symbol or CNS-VS Symbol Digit Test
timeFrame: Baseline
measure: Processing Speed-Grooved Pegboard
timeFrame: Baseline
measure: Pulmonary Function
timeFrame: Baseline
measure: Echocardiogram
timeFrame: Baseline
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kevin Krull, PhD
role: PRINCIPAL_INVESTIGATOR
References: