SurvivorshipNCT05342155
Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes
An observational study of Survivorship and Childhood Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Some childhood cancer survivors have health problems as the result of previous cancer treatment. This study is being done to determine if we can better predict the risk a childhood cancer survivor might have for developing future health issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship, Childhood Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- ≥18 years of age at the time of study
- Enrolled on SJLIFE
- ≥5 years from initial diagnosis of pediatric cancer/malignancy
- Currently not receiving cancer therapies
- Access to web-enabled smartphone
Who cannot join
- Known severe neurocognitive impairment (e.g., estimated intelligence score [FSIQ] <70), which requires proxies to complete daily symptom and PRO surveys;
- <3rd-grade reading level or not able to communicate in English;
- Currently pregnant or reports planning to become pregnant in the next two years;
- Lack of access to web-enabled smartphone, or not able to use/access internet from the device.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Some childhood cancer survivors have health problems as the result of previous cancer treatment. This study is being done to determine if we can better predict the risk a childhood cancer survivor might have for developing future health issues.
The goal of this study is to enable regular monitoring of patient-generated health data (PGHD), including symptoms, physical activity, energy expenditure, sleep behavior and heart rate variability, and utilize these data in predicting survivor-specific risk of late effects to improve survivorship care and outcomes.
Read the detailed description
This study is designed to collect symptoms/other PGHD as risk factors of subsequent adverse outcomes, including PROs (impaired QOL, unplanned healthcare use) assessed via smartphones, and clinical outcomes (physical performance deficits, onset of/worsening CHCs) assessed at SJCRH's After Completion of Therapy (ACT) Clinic. Each survivor will be assessed at 6 timepoints over 2-year period: T0 (baseline: week 0) for assessing baseline PROs and clinical outcomes at ACT Clinic; T1 (7 days in week 1), T2 (7 days in week 5) and T3 (7 days in week 9) for collecting symptoms/PGHD and PROs in non-clinical, daily-living settings; T4 (week 60) and T5 (week 108) for collecting PRO and clinical outcomes at ACT Clinic. Survivors will report symptoms/PGHD over a 3-month period for a purpose of collecting risk factors.
Primary Objective
Aim 1: Use a mHealth platform to collect and integrate symptoms, activity, and health behavioral data, and develop/validate risk prediction models for future QOL outcomes using these dynamic data.
Aim 1a: Investigate variability of patient-generated health data (PGHD), i.e., symptoms (via smartphone), and physical activity, energy expenditure, sleep behavior and heart rate variability (via wearable accelerometer/biometric sensor) within and between survivors with special attention to their temporal change patterns.
Aim 1b: Assess associations and temporal patterns of the mHealth-collected PGHD while considering clinical (cancer treatment exposure/doses, age at cancer diagnosis, childhood cancer types, etc.) and socio-demographic (age at study, sex, educational attainment, income, etc.) factors.
Aim 1c: Develop risk prediction models for future QOL outcomes using training data with cross-validation and validate model performance using independent test data.
Aim 1d: Establish personalized risk prediction scores for potential use within clinical settings.
Secondary Objectives
Aim 2: Develop/validate risk prediction models and establish personalized risk prediction scores for other outcomes (unplanned care utilization including emergency room visits and hospitalizations, physical performance deficits, onset of chronic health conditions) using the same approach as Aim 1.
Aim 3: Create a web-based tool to calculate and report personalized outcome specific risks and facilitate integration of risk scores into the survivor's patient portal and hospital's EHR for potential future use/evaluation in clinical management.
- Conditions
- Survivorship, Childhood Cancer
- Keywords
- Health Data
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | For the focus group, the participant will be asked to review the potential platform the investigators are developing to better describe risks of health are developing to better describe risks of health issues in childhood cancer survivors. The focus group session will last approximately 2 hours. | |
| Campus and Home Assessments | For the campus and home assessments, the participant will be engaged in the research activities over 108 weeks (approximately 2 years). DatStat Connect app-Throughout participation in this research study, the participant will use a personal compatible device, such as smartphone or tablet, to report information about their health and respond to questionnaires using a website app called DatStat Connect. The wrist monitor (Actigraph) and heart monitor (CorSense) will also transmit information to DatStat Connect. The wrist monitor and heart monitor will connect to a compatible personal device via Bluetooth. The wrist monitor and heart CorSense device and St Jude Life study visit St Jude LIFE study visit: the participant will be asked to complete a St Jude LIFE research study assessment on the St Jude campus at three timepoints: initial visit (Week 0),approximately end of Year 1 (Week 60), and approximately end of Year 2 (Week 108). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom log
Log of patient reported symptoms
Measured: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Euro QoL 5D
Quality of Life Survey
Measured: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
NIH PROMIS 45
Patient report outcomes
Measured: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
QLACS
Quality of Life in Adult Cancer Survivors Survey
Measured: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
MEPS-US Medical Expenditure Panel Survey
Unplanned health care utilization (emergency room visits, hospitalization, unplanned primary care physician visit)
Measured: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Chronic health conditions log
Log of patient reported chronic health condition status
Measured: Baseline, week 60 and week 108
Physical performance-Cardiopulmonary fitness
Cardiopulmonary fitness - six minute walk and cardiopulmonary exercise testing
Measured: Baseline , week 60 and week 108
Physical performance-Muscular strength and endurance
Muscular strength and endurance - Isometric grip strength, isokinetic knee extension and ankle dorsiflexion (Biodex System 4)
Measured: Baseline, week 60 and week 108
Physical performance-Flexibility
Flexibility - Sit and reach test (Flex-Tester), passive ankle range of motion
Measured: Baseline, week 60 and week 108
Physical performance-Mobility
Mobility - Timed up and go test
Measured: Baseline, week 60 and week 108
Physical performance-Balance and sensory integrity
Balance and sensory integrity - Computerized dynamic posturography (SMART Equi Test)
Measured: Baseline, week 60 and week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start20 Mar 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- I-Chang Huang, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342155
- Sponsor's protocol ID
- HEALTHSHR
- Other IDs
- 1R01CA258193-01
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2022
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes
- ClinicalTrials.gov ID
- NCT05342155
- Acronym / sponsor ID
- HEALTHSHR
- Conditions
- Survivorship, Childhood Cancer
- Keywords
- Health Data
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 602 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 22 Apr 2022 (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.
Some childhood cancer survivors have health problems as the result of previous cancer treatment. This study is being done to determine if we can better predict the risk a childhood cancer survivor might have for developing future health issues.
The goal of this study is to enable regular monitoring of patient-generated health data (PGHD), including symptoms, physical activity, energy expenditure, sleep behavior and heart rate variability, and utilize these data in predicting survivor-specific risk of late effects to improve survivorship care and outcomes.
Detailed description
This study is designed to collect symptoms/other PGHD as risk factors of subsequent adverse outcomes, including PROs (impaired QOL, unplanned healthcare use) assessed via smartphones, and clinical outcomes (physical performance deficits, onset of/worsening CHCs) assessed at SJCRH's After Completion of Therapy (ACT) Clinic. Each survivor will be assessed at 6 timepoints over 2-year period: T0 (baseline: week 0) for assessing baseline PROs and clinical outcomes at ACT Clinic; T1 (7 days in week 1), T2 (7 days in week 5) and T3 (7 days in week 9) for collecting symptoms/PGHD and PROs in non-clinical, daily-living settings; T4 (week 60) and T5 (week 108) for collecting PRO and clinical outcomes at ACT Clinic. Survivors will report symptoms/PGHD over a 3-month period for a purpose of collecting risk factors.
Primary Objective
Aim 1: Use a mHealth platform to collect and integrate symptoms, activity, and health behavioral data, and develop/validate risk prediction models for future QOL outcomes using these dynamic data.
Aim 1a: Investigate variability of patient-generated health data (PGHD), i.e., symptoms (via smartphone), and physical activity, energy expenditure, sleep behavior and heart rate variability (via wearable accelerometer/biometric sensor) within and between survivors with special attention to their temporal change patterns.
Aim 1b: Assess associations and temporal patterns of the mHealth-collected PGHD while considering clinical (cancer treatment exposure/doses, age at cancer diagnosis, childhood cancer types, etc.) and socio-demographic (age at study, sex, educational attainment, income, etc.) factors.
Aim 1c: Develop risk prediction models for future QOL outcomes using training data with cross-validation and validate model performance using independent test data.
Aim 1d: Establish personalized risk prediction scores for potential use within clinical settings.
Secondary Objectives
Aim 2: Develop/validate risk prediction models and establish personalized risk prediction scores for other outcomes (unplanned care utilization including emergency room visits and hospitalizations, physical performance deficits, onset of chronic health conditions) using the same approach as Aim 1.
Aim 3: Create a web-based tool to calculate and report personalized outcome specific risks and facilitate integration of risk scores into the survivor's patient portal and hospital's EHR for potential future use/evaluation in clinical management.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | –For the focus group, the participant will be asked to review the potential platform the investigators are developing to better describe risks of health are developing to better describe risks of health issues in childhood cancer survivors. The focus group session will last approximately 2 hours. |
| Campus and Home Assessments | – | –For the campus and home assessments, the participant will be engaged in the research activities over 108 weeks (approximately 2 years). DatStat Connect app-Throughout participation in this research study, the participant will use a personal compatible device, such as smartphone or tablet, to report information about their health and respond to questionnaires using a website app called DatStat Connect. The wrist monitor (Actigraph) and heart monitor (CorSense) will also transmit information to DatStat Connect. The wrist monitor and heart monitor will connect to a compatible personal device via Bluetooth. The wrist monitor and heart CorSense device and St Jude Life study visit St Jude LIFE study visit: the participant will be asked to complete a St Jude LIFE research study assessment on the St Jude campus at three timepoints: initial visit (Week 0),approximately end of Year 1 (Week 60), and approximately end of Year 2 (Week 108). |
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 (5 listed)
- ≥18 years of age at the time of study
- Enrolled on SJLIFE
- ≥5 years from initial diagnosis of pediatric cancer/malignancy
- Currently not receiving cancer therapies
- Access to web-enabled smartphone
Key exclusion criteria (4 listed)
- Known severe neurocognitive impairment (e.g., estimated intelligence score [FSIQ] <70), which requires proxies to complete daily symptom and PRO surveys;
- <3rd-grade reading level or not able to communicate in English;
- Currently pregnant or reports planning to become pregnant in the next two years;
- Lack of access to web-enabled smartphone, or not able to use/access internet from the device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom log
Time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Log of patient reported symptoms
Euro QoL 5D
Time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Quality of Life Survey
NIH PROMIS 45
Time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Patient report outcomes
QLACS
Time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Quality of Life in Adult Cancer Survivors Survey
MEPS-US Medical Expenditure Panel Survey
Time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
Unplanned health care utilization (emergency room visits, hospitalization, unplanned primary care physician visit)
Chronic health conditions log
Time frame: Baseline, week 60 and week 108
Log of patient reported chronic health condition status
Physical performance-Cardiopulmonary fitness
Time frame: Baseline , week 60 and week 108
Cardiopulmonary fitness - six minute walk and cardiopulmonary exercise testing
Physical performance-Muscular strength and endurance
Time frame: Baseline, week 60 and week 108
Muscular strength and endurance - Isometric grip strength, isokinetic knee extension and ankle dorsiflexion (Biodex System 4)
Physical performance-Flexibility
Time frame: Baseline, week 60 and week 108
Flexibility - Sit and reach test (Flex-Tester), passive ankle range of motion
Physical performance-Mobility
Time frame: Baseline, week 60 and week 108
Mobility - Timed up and go test
Physical performance-Balance and sensory integrity
Time frame: Baseline, week 60 and week 108
Balance and sensory integrity - Computerized dynamic posturography (SMART Equi Test)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
I-Chang Huang, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivorship and Childhood Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Symptom log (time frame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period). The study lists 11 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 24 Aug 2026.