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

NCT ID: NCT07222358

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

St. Jude Alumni St. Jude Life Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Remote Monitoring Program

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephanie E Dixon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephanie Dixon, MD, MPH

Role: CONTACT

Phone: 866-278-5833

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stephanie Dixon, MD, MPH

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RAIS

Identifier Type: -

Identifier Source: org_study_id