Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Participation rate
Study Overview
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).
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Remote Monitoring Program (Behavioral)
Outcomes
Primary Outcomes
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
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
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.
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
Secondary Outcomes
No secondary outcomes reported