Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery

March 31, 2026 updated by: St. Jude Children's Research Hospital

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.

  • 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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

Description

Inclusion Criteria:

  • Participant is ≥18 years of age
  • 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 uses a continuous glucose monitor for diabetes management or has diabetes requiring insulin or more than 1 agent for treatment at baseline
  • Participant is currently enrolled on an intervention or active longitudinal monitoring ancillary study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate
Time Frame: Assessed at contact for enrollment of each participant (baseline/screening).
The proportion of eligible survivors approached who enroll in the intervention
Assessed at contact for enrollment of each participant (baseline/screening).
Completion rate
Time Frame: Baseline at study entry through week 12
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
Time Frame: Baseline at study entry through week 12
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
On-boarding rate
Time Frame: Baseline at study entry through week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Stephanie E Dixon, MD, MPH, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Actual)

October 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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