Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

NCT ID: NCT05342155

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 602 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2028-06-20

Brief 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.

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.

Conditions

Survivorship; Childhood Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ≥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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Chang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

1R01CA258193-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HEALTHSHR

Identifier Type: -

Identifier Source: org_study_id