Feasibility and Acceptability of Remote Saliva Collection
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.
연구 개요
상태
개입 / 치료
- 진단 검사: Salivary Cortisol Collection
- 진단 검사: Blood Biomarker Collection
- 진단 검사: Hair Cortisol Collection
- 진단 검사: Nail Cortisol Collection
- 진단 검사: WatchPAT Sleep Assessment
- 행동: Morning and Evening Diaries
- 다른: MEMS Cap Adherence Monitoring
- 다른: OnTimePoint Application
- 다른: Survey and Questionnaire Assessment
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Bria Gresham, PhD
- 전화번호: 866-278-5833
- 이메일: referralinfo@stjude.org
연구 장소
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38105
- 모병
- St. Jude Children's Research Hospital
-
연락하다:
- Bria Gresham, PhD
- 전화번호: 866-278-5833
- 이메일: referralinfo@stjude.org
-
수석 연구원:
- Bria Gresham, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The study population will include child and adolescent survivors of ALL, their siblings, and caregivers.
설명
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:
- TOTAL Therapy study XVI for Newly Diagnosed Patients with ALL (TOTXVI) OR
- Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma (TOT17)
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The survivor is cancer-free.
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The survivor is at least 5 years out from the ALL diagnosis.
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The survivor is at least 2 years out from completion of treatment.
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The survivor did not receive cranial therapy as part of ALL therapy.
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The survivor is aged ≥8 to 18 years old at the time of enrollment.
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The survivor has completed their After Completion of Therapy (ACT) clinic consultation.
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The survivor is able to speak and read English.
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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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.
다른 이름들:
FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.
다른 이름들:
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. Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.
다른 이름들:
Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times. 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. |
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.
다른 이름들:
FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.
다른 이름들:
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. Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.
다른 이름들:
Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times. 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. |
Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Enrollment Feasibility
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Saliva Sampling Acceptability-Acceptability Measure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bria Gresham, PhD, St. Jude Children's Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FARSC
- U54CA302464 (미국 NIH 보조금/계약)
- NCI-2026-06979 (기타 식별자: NCI Clinical Trial Registration Program)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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