Feasibility of Remote Saliva and Sleep Monitoring for ALL Survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores the practicality and acceptability of collecting multiple biological samples and sleep data from childhood ALL survivors and their siblings. Participants complete enrollment, baseline, and telehealth visits and may do activities remotely or in person. Saliva samples are collected at home five times per day over three days, plus blood, hair, and nail samples, sleep data from a WatchPAT device, and diary questionnaires. Caregivers provide household information and feedback on acceptability. The study also examines how cancer treatment history and neighborhood conditions might influence stress-related biology and long-term health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

SURVIVORS

* The survivor is a childhood survivor of Acute Lymphocytic Leukemia (ALL).
* The survivor was treated on one of the following St. Jude Total Therapy Studies:

  1. TOTAL Therapy study XVI for Newly Diagnosed Patients with ALL (TOTXVI) OR
  2. Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma (TOT17)
* The survivor is cancer-free.
* The survivor is at least 5 years out from the ALL diagnosis.
* The survivor is at least 2 years out from completion of treatment.
* The survivor did not receive cranial therapy as part of ALL therapy.
* The survivor is aged ≥8 to 18 years old at the time of enrollment.
* The survivor has completed their After Completion of Therapy (ACT) clinic consultation.
* The survivor is able to speak and read English.
* The survivor has internet access.

SIBLINGS

* The sibling has a brother or sister who is an ALL survivor participating in this study.
* The sibling is aged ≥8 to18 years old at the time of enrollment.
* The sibling is able to speak and read English.
* The sibling has internet access.

CAREGIVERS

* The caregiver provides primary care or support to an ALL survivor that is in this study.
* The caregiver resides in the home full-time with enrolled survivor and sibling.
* The caregiver is able to speak and read English.
* The caregiver has internet access.
* The caregiver is willing and able to assist with at home biospecimen collection.

Exclusion Criteria:

SURVIVORS and SIBLINGS

* Survivor and/or sibling has a diagnosis of Down's Syndrome.
* Survivor and/or sibling has a diagnosis of autism spectrum disorder.
* Survivor and/or sibling has a diagnosis of another pervasive developmental disorder not listed above.
* Survivor and/or sibling has a history of prolonged treatment with steroid medications or systemic glucocorticoids for reasons other than ALL.
* Survivor and/or sibling resides outside of the United States.
* Inability or unwillingness of survivor and/or sibling and/or legal guardian/representative to give written informed consent.

CAREGIVERS Note: There are no exclusion criteria for caregivers.

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Bria Gresham, PhD — St. Jude Children's Research Hospital
• Study coordinator: Bria Gresham, PhD
• Email: referralinfo@stjude.org
• Phone: 866-278-5833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.