Characterizing Sleep Among Long-term Survivors of Childhood Cancer (NCT05480904) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Characterizing Sleep Among Long-term Survivors of Childhood Cancer
United States199 participantsStarted 2023-04-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at sleep problems and fatigue in long-term survivors of childhood cancers like ALL, CNS tumors, and solid tumors — given my history, does my doctor think my sleep issues might be related to my cancer treatment, and would participating in this kind of research be worth discussing?
2The trial uses at-home sleep monitoring devices like the Sleep Profiler and WatchPAT alongside questionnaires about insomnia, fatigue, pain, and body clock patterns — can my doctor explain what's actually involved in completing all of these, and how much time and effort it would realistically take?
3Since this study is 'active not recruiting,' does my doctor know of any similar observational sleep studies that are currently enrolling long-term childhood cancer survivors, in case this one is no longer an option for me?
4This is a non-interventional, observational study — meaning it's gathering information rather than testing a treatment — so can my doctor help me understand whether joining something like this could still benefit my care, or whether it's primarily contributing to research for future survivors?
5Given that sleep problems, fatigue, and pain are all being measured together in this trial, can my doctor tell me whether there are existing treatments or referrals — like a sleep specialist or pain management program — that might already address these issues for me while I look into whether research participation makes sense?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insomnia Severity Index (ISI)
Timeframe: Baseline
2
CSALTS Sleep Survey
Timeframe: Baseline
3
Morningness-Eveningness Questionnaire (MEQ)
Timeframe: Baseline
4
Circadian Type Inventory (CTI)
Timeframe: Baseline
5
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
Timeframe: Baseline
6
CSALTS Pain Survey
Timeframe: Baseline for 2 nights
7
Polysomnography Evaluation (Sleep Profiler PSG2 or WatchPAT)