Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT07222358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: