Characterizing Sleep Among Long-term Survivors of Childhood Cancer

St. Jude Children's Research Hospital

Status: Enrolling

Conditions: Solid Tumor; ALL, Adult; CNS Tumor

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

Study type: Observational

Funder types: Other

Identifiers

NCT05480904

NCI-2022-08555 (Registry Identifier)

CSALTS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

On campus

Description:

SJLIFE Study Campus Visit

Treatment:

Diagnostic Test: Pulmonary Function

Other: Neurocognitive (Thinking) Testing

Device: Remote Polysomnography

Other: Health Questionnaires, Sleep Surveys & Sleep Diary

Diagnostic Test: Physical Function

Diagnostic Test: Echocardiography/EKG

Remote

Description:

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

Treatment:

Diagnostic Test: CNS Vital Signs (Thinking) Testing

Device: Remote Polysomnography

Other: Health Questionnaires, Sleep Surveys & Sleep Diary