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

St. Jude Children's Research Hospital

Status: Not yet enrolling

Conditions: Childhood Cancer

Treatments: Behavioral: Remote Monitoring Program

Study type: Observational

Funder types: Other

Identifiers

NCT07222358

RAIS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Remote Monitoring Group

Description:

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.

Treatment:

Behavioral: Remote Monitoring Program