Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer; Survivorship

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 Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: I-Chang Huang, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: I-Chan Huang, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom log	Log of patient reported symptoms	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	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	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	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)	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	Baseline, week 60 and week 108
Physical performance-Cardiopulmonary fitness	Cardiopulmonary fitness - six minute walk and cardiopulmonary exercise testing	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)	Baseline, week 60 and week 108
Physical performance-Flexibility	Flexibility - Sit and reach test (Flex-Tester), passive ankle range of motion	Baseline, week 60 and week 108
Physical performance-Mobility	Mobility - Timed up and go test	Baseline, week 60 and week 108
Physical performance-Balance and sensory integrity	Balance and sensory integrity - Computerized dynamic posturography (SMART Equi Test)	Baseline, week 60 and week 108

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: I-Chang Huang, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Health Data
• Other Study ID Numbers: HEALTHSHR; 1R01CA258193-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No