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

NCT07222358 | Not Yet Recruiting

• 1 other identifier: RAIS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Childhood Cancer

Keywords

St. Jude Alumni; St. Jude Life Participants

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Remote Monitoring Program BEHAVIORAL

* 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.

Remote Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Stephanie E Dixon, MD, MPH

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Dixon, MD, MPH

CONTACT

866-278-5833; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)