Childhood CancerNCT07222358
Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
An observational study of Childhood Cancer, run by St. Jude Children's Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Remote Monitoring Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Aug 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
- 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).
Read the 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
- Childhood Cancer
- Being tested
- Remote Monitoring Program
- Keywords
- St. Jude Alumni, St. Jude Life Participants
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring ProgramBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote Monitoring Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
The proportion of eligible survivors approached who enroll in the intervention
Measured: Assessed at contact for enrollment of each participant (baseline/screening).
On-boarding rate
The proportion of consented participants who successful onboard with the vendor and contribute any study data beyond baseline
Measured: Baseline at study entry through week 12
Completion rate
The proportion of enrolled survivors who remain on study and complete both baseline and week 12/end of study assessments.
Measured: Baseline at study entry through week 12
Adherence to the remote monitoring intervention
The proportion of enrolled survivors who complete at least 2/3 of the pre-specified remote monitoring study components
Measured: Baseline at study entry through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: After PI and vendor discussions, the decision was made not to proceed with the contract. The vendor's focus on large commercial efforts limits feasibility to support St. Jude clinical trial work.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie E Dixon, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222358
- Sponsor's protocol ID
- RAIS
- Status last verified
- Mar 2026
- First submitted
- 27 Oct 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
- ClinicalTrials.gov ID
- NCT07222358
- Acronym / sponsor ID
- RAIS
- Conditions
- Childhood Cancer
- Keywords
- St. Jude Alumni, St. Jude Life Participants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After PI and vendor discussions, the decision was made not to proceed with the contract. The vendor's focus on large commercial efforts limits feasibility to support St. Jude clinical trial work.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring Group | – | Behavioral: Remote Monitoring ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Remote Monitoring Group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie E Dixon, MD, MPH principal investigator
St. Jude Children's Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer, run by St. Jude Children's Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: Assessed at contact for enrollment of each participant (baseline/screening).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.