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After PI and vendor discussions, the decision was made not to proceed with the contract. The vendor's focus on large commercial efforts limits feasibility to support St. Jude clinical trial work.
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This feasibility study evaluates a 12-week, multi-component remote assessment program for adult survivors of childhood cancer. The study aims to determine the participation and adherence rates to remote monitoring of cardiometabolic health using wearable devices, surveys, and laboratory testing facilitated by a third-party vendor.
Primary Objective - To establish the feasibility of a multi-component remote assessment program for adult survivors.
Secondary Objective
Survivors of childhood cancer face increased risks of late effects, including cardiometabolic conditions. Due to geographic diversity and mobility limitations, remote research participation is essential. This study pilots a remote assessment platform to monitor cardiometabolic health indicators such as blood pressure, heart rate variability, glucose control, physical activity, sleep, diet, and laboratory biomarkers. Participants will be on-boarded by a vendor, receive devices, and complete assessments remotely. A subset will participate in interviews to evaluate platform acceptability and barriers. The study will assess feasibility through participation and adherence rates, aiming to inform future remote intervention trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Monitoring Group | Participants will undergo a 12-week remote monitoring program using wearable devices and complete surveys and a one-time lab draw. A subset will participate in interviews post-intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Monitoring Program | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Participation rate | The proportion of eligible survivors approached who enroll in the intervention | Assessed at contact for enrollment of each participant (baseline/screening). |
| On-boarding rate | The proportion of consented participants who successful onboard with the vendor and contribute any study data beyond baseline | Baseline at study entry through week 12 |
| Completion rate | The proportion of enrolled survivors who remain on study and complete both baseline and week 12/end of study assessments. | Baseline at study entry through week 12 |
| Adherence to the remote monitoring intervention | The proportion of enrolled survivors who complete at least 2/3 of the pre-specified remote monitoring study components | Baseline at study entry through week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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All participants who meet eligibility criteria and consent to enrollment on the study.
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie E Dixon, MD, MPH | St. Jude Children's Research Hospital | Principal Investigator |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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A one-time blood sample (30 mL) will be collected from each participant either at home or at a local facility. The sample will include clinical laboratory tests such as Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), lipids, HbA1c, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). The remaining portion of the sample will be banked at St. Jude Children's Research Hospital for future research.
Retained blood samples may contain DNA and could be used for future genetic or molecular analyses.
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