Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT07222358

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
St. Jude Children's Research Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRemote 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.

Timeline

Start date
2026-04-01
Primary completion
2026-08-01
Completion
2027-08-01
First posted
2025-10-29
Last updated
2026-04-06

Source: ClinicalTrials.gov record NCT07222358. Inclusion in this directory is not an endorsement.