Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
NCT ID: NCT07222358
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-01-31
2027-08-31
Brief Summary
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Primary Objective - To establish the feasibility of a multi-component remote assessment program for adult survivors.
* The primary outcome for feasibility will be the participation rate (# eligible survivors approached who enroll) and completion rate (# of eligible survivors who enroll and remain on study through completion).
* An additional outcome for feasibility will be adherence to the multicomponent remote assessment among participants.
Secondary Objective
* To estimate the proportion of participants who complete each individual study component (adherence to each individual component monitoring).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Remote Monitoring Program
* Participants receive devices (Apple Watch, blood pressure monitor, Continuous Glucose Monitor (CGM), scale, measuring tape).
* Monitoring includes ECG, blood pressure, glucose, weight, waist circumference, physical activity, and sleep.
* Surveys include health status, medication use, personality traits, and acceptability measures.
* One-time blood draw includes CBC, CMP, lipids, HbA1c, NT-proBNP
* Food logging during CGM use.
* Semi-structured interviews post-study for a subset.
Interventions
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Remote Monitoring Program
* Participants receive devices (Apple Watch, blood pressure monitor, Continuous Glucose Monitor (CGM), scale, measuring tape).
* Monitoring includes ECG, blood pressure, glucose, weight, waist circumference, physical activity, and sleep.
* Surveys include health status, medication use, personality traits, and acceptability measures.
* One-time blood draw includes CBC, CMP, lipids, HbA1c, NT-proBNP
* Food logging during CGM use.
* Semi-structured interviews post-study for a subset.
Eligibility Criteria
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Inclusion Criteria
* Participant is enrolled in the St. Jude Life (SJLIFE) cohort
* Participant is able and willing to provide informed consent
* Participant has signed a separate consent for the St. Jude banking protocol (TBANK)
* Participant received anthracycline (≥100 mg/m²), chest or abdominal radiation as part of childhood cancer treatment
* Participant owns a SmartPhone compatible with the vendor platform, Apple HealthKit, and Dexcom (a wearable device that continuously tracks glucose levels)
* Participant verbalizes understanding directions for completing remote study activities with the third-party partner
* Participant is fluent in English
Exclusion Criteria
* Participant is currently enrolled on an intervention or active longitudinal monitoring ancillary study
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Stephanie E Dixon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie Dixon, MD, MPH
Role: primary
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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RAIS
Identifier Type: -
Identifier Source: org_study_id