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Feasibility and Acceptability of Remote Saliva Collection

2 listopada 2026 zaktualizowane przez: St. Jude Children's Research Hospital

The purpose of this study is to evaluate the practicality and acceptability of collecting biological samples and health information from childhood survivors of acute lymphoblastic leukemia (ALL) and their siblings. Participants will provide saliva, blood, hair, and fingernail samples, complete questionnaires, and participate in sleep monitoring. The information collected will help researchers understand how cancer treatment and neighborhood conditions may affect stress hormones, inflammation, and long-term health.

Primary Objective

- To evaluate the feasibility of collecting multiple biological specimens, surveys, and sleep assessment among child and adolescent survivors of ALL and their siblings.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Childhood survivors of acute lymphoblastic leukemia (ALL) can experience long-term health problems after cancer treatment. Researchers believe that stress-related biological processes and social factors, such as neighborhood socioeconomic conditions, may influence long-term health outcomes. However, it is not known whether collecting multiple biological samples over several days is practical for survivors and their families.

This feasibility and acceptability study will enroll survivors of childhood ALL, their siblings, and caregivers. Participants may complete study activities through a combination of in-person and remote procedures or through a fully remote option.

Participants will complete an enrollment visit, a baseline visit conducted either in person or remotely, and a telehealth reminder visit. Survivors and siblings will provide saliva, blood, hair, and fingernail samples. Saliva samples will be collected at home five times per day over three days. Participants will also wear a WatchPAT sleep monitoring device and complete morning and evening diaries during the saliva collection period. Questionnaires will assess demographic information, sleep, emotional well-being, family relationships, health behaviors, and other factors that may influence cortisol measurements. Caregivers will complete questionnaires about household and demographic characteristics and provide feedback regarding study acceptability.

Blood samples will be used to measure markers of inflammation and hormone function. Saliva, hair, and fingernail samples will be used to evaluate cortisol, a biological marker related to stress and hypothalamic-pituitary-adrenal (HPA) axis functioning. The study will also explore associations between neighborhood socioeconomic status and biological measures of cortisol and inflammation. Findings from this feasibility study will be used to inform the design of future research investigating the effects of cancer treatment and social environments on long-term health outcomes among childhood ALL survivors.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38105
        • Rekrutacyjny
        • St. Jude Children's Research Hospital
        • Kontakt:
        • Główny śledczy:
          • Bria Gresham, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

8 lat do 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population will include child and adolescent survivors of ALL, their siblings, and caregivers.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Childhood ALL Survivors

Childhood survivors of acute lymphoblastic leukemia treated on St. Jude Total Therapy XVI or Total Therapy 17 protocols who meet survivorship and age eligibility requirements.
Test diagnostyczny: Salivary Cortisol Collection

Participants collect five saliva samples per day on three days within a 14-day period (wake, +30 min, +45 min, +60 min, bedtime) to assess diurnal cortisol rhythm and cortisol awakening response.

Inne nazwy:
  • Saliva Sampling; Saliva Collection
Test diagnostyczny: Blood Biomarker Collection

Collection of blood samples to measure high-sensitivity C-reactive protein, pro-inflammatory cytokines, dehydroepiandrosterone, and luteinizing hormone. Hybrid participants undergo venipuncture (~3 mL blood). Remote participants use the FDA-approved RedDrop One capillary blood collection device.

Inne nazwy:
  • Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood Collection
Test diagnostyczny: Hair Cortisol Collection

Collection of a small hair sample from the posterior vertex of the scalp to measure long-term cortisol exposure. Hair is cut close to the scalp and stored for laboratory analysis.

Inne nazwy:
  • Hair Sample Collection
Test diagnostyczny: Nail Cortisol Collection

Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.

Inne nazwy:
  • Fingernail Collection; Nail Sample Collection
Test diagnostyczny: WatchPAT Sleep Assessment

FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.

Inne nazwy:
  • WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor
Behawioralne: Morning and Evening Diaries

Participants complete brief morning and evening diaries to record sleep, caffeine intake, medication use, symptoms, stress, affect, daily events, and other factors that may influence cortisol measurements.

Inny: MEMS Cap Adherence Monitoring

Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.

Inne nazwy:
  • Aardex MEMS Caps; Medication Event Monitoring System Caps
Inny: OnTimePoint Application

Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times.

Inny: Survey and Questionnaire Assessment

Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers.
Siblings of ALL Survivors

Biological or household siblings of enrolled ALL survivors, aged 8-18 years.
Test diagnostyczny: Salivary Cortisol Collection

Participants collect five saliva samples per day on three days within a 14-day period (wake, +30 min, +45 min, +60 min, bedtime) to assess diurnal cortisol rhythm and cortisol awakening response.

Inne nazwy:
  • Saliva Sampling; Saliva Collection
Test diagnostyczny: Blood Biomarker Collection

Collection of blood samples to measure high-sensitivity C-reactive protein, pro-inflammatory cytokines, dehydroepiandrosterone, and luteinizing hormone. Hybrid participants undergo venipuncture (~3 mL blood). Remote participants use the FDA-approved RedDrop One capillary blood collection device.

Inne nazwy:
  • Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood Collection
Test diagnostyczny: Hair Cortisol Collection

Collection of a small hair sample from the posterior vertex of the scalp to measure long-term cortisol exposure. Hair is cut close to the scalp and stored for laboratory analysis.

Inne nazwy:
  • Hair Sample Collection
Test diagnostyczny: Nail Cortisol Collection

Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.

Inne nazwy:
  • Fingernail Collection; Nail Sample Collection
Test diagnostyczny: WatchPAT Sleep Assessment

FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.

Inne nazwy:
  • WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor
Behawioralne: Morning and Evening Diaries

Participants complete brief morning and evening diaries to record sleep, caffeine intake, medication use, symptoms, stress, affect, daily events, and other factors that may influence cortisol measurements.

Inny: MEMS Cap Adherence Monitoring

Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.

Inne nazwy:
  • Aardex MEMS Caps; Medication Event Monitoring System Caps
Inny: OnTimePoint Application

Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times.

Inny: Survey and Questionnaire Assessment

Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers.
Caregivers

Primary caregivers residing full-time with enrolled survivors and siblings.
Inny: Survey and Questionnaire Assessment

Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Enrollment Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants approached that enroll in the study
Baseline through study completion, approximately 3 months after enrollment
Saliva Sampling Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants who complete the saliva sampling procedures will adhere to the timing of the saliva sampling
Baseline through study completion, approximately 3 months after enrollment
Blood Sampling Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled who complete the blood sample collection
Baseline through study completion, approximately 3 months after enrollment
Hair Sampling Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed the hair sample collection
Baseline through study completion, approximately 3 months after enrollment
Fingernail Sampling Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed the fingernail sample collection
Baseline through study completion, approximately 3 months after enrollment
Overall Study Procedure Feasibility
Ramy czasowe: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed each study procedure
Baseline through study completion, approximately 3 months after enrollment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Saliva Sampling Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of saliva sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Blood Sampling Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of blood sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Hair Sampling Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of hair sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Fingernail Sampling Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of fingernail sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Overall Biospecimen Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of overall biospecimen acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Overall Study Procedure Acceptability-Acceptability Measure
Ramy czasowe: Post study, approximately 3 months after enrollment

A measure of overall study acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of overall study acceptability.
Post study, approximately 3 months after enrollment
Neighborhood Socioeconomic Status (nSES)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with cortisol awakening response. Cortisol awakening response will be measured via the slope of four morning saliva samples (upon waking, +30 minutes, +45 minutes, +60 minutes) across three days, with values at each time point averaged across days.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Cortisol Diurnal Rhythm
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with cortisol diurnal rhythm. Cortisol diurnal rhythm will be measured via the slope of five daily saliva samples (upon waking, +30 minutes, +45 minutes, +60 minutes, bedtime) across three days, with values at each time point averaged across days.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Hair Cortisol Concentration
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with hair cortisol concentration. Hair cortisol concentration will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Nail Cortisol Concentration
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with nail cortisol concentration. Nail cortisol concentration will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and High-Sensitivity C-Reactive Protein (hs-CRP)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with high-sensitivity c-reactive protein (hs-CRP). Plasma hs-CRP will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interferon gamma (IFN-y)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interferon gamma (IFN-y). Plasma IFN-y will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 1 beta (IL-1β)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 1 beta (IL-1β). Plasma IL-1β will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 2 (IL-2)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 2 (IL-2). Plasma IL-2 will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 4 (IL-4)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 4 (IL-4). Plasma IL-4 will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 6 (IL-6)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 6 (IL-6). Plasma IL-6 will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 10 (IL-10)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 10 (IL-10). Plasma IL-10 will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 12 (IL-12p70)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 12 (IL-12p70). Plasma IL-12p70 will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 17A (IL-17A)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 17A (IL-17A). Plasma IL-17A will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Tumor Necrosis Factor - alpha (TNF- α)
Ramy czasowe: Post study, approximately 6 months after accrual ends

Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with Tumor Necrosis Factor - alpha (TNF- α). Plasma (TNF- α) will be evaluated as a continuous measure.
Post study, approximately 6 months after accrual ends

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

St. Jude Children's Research Hospital

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Bria Gresham, PhD, St. Jude Children's Research Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2028

Ukończenie studiów (Szacowany)

1 października 2029

Daty rejestracji na studia

Pierwszy przesłany

25 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 października 2026

Pierwszy wysłany (Rzeczywisty)

20 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FARSC
  • U54CA302464 (Grant/umowa NIH USA)
  • NCI-2026-06979 (Inny identyfikator: NCI Clinical Trial Registration Program)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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