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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Bria Gresham, PhD
- 电话号码：866-278-5833
- 邮箱：referralinfo@stjude.org
学习地点
-
-
Tennessee
-
Memphis、Tennessee、美国、38105
- 招聘中
- St. Jude Children's Research Hospital
-
接触：
- Bria Gresham, PhD
- 电话号码：866-278-5833
- 邮箱：referralinfo@stjude.org
-
首席研究员：
- Bria Gresham, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population will include child and adolescent survivors of ALL, their siblings, and caregivers.
描述
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)
-
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
其他名称：
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.
其他名称：
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.
其他名称：
Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.
其他名称：
FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.
其他名称：
FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.
其他名称：
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.
其他名称：
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Enrollment Feasibility
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Saliva Sampling Acceptability-Acceptability Measure
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Bria Gresham, PhD、St. Jude Children's Research Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FARSC
- U54CA302464 (美国 NIH 拨款/合同)
- NCI-2026-06979 (其他标识符：NCI Clinical Trial Registration Program)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.