Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

Survivorship Clinical Trial

Official title:

Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342155
• Other study ID #: HEALTHSHR
• Secondary ID: 1R01CA258193-01
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: June 20, 2026

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: I-Chang Huang, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 20, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer
• Survivorship

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Chronic health conditions log	Log of patient reported chronic health condition status	Baseline, week 60 and week 108
Primary	Physical performance-Cardiopulmonary fitness	Cardiopulmonary fitness - six minute walk and cardiopulmonary exercise testing	Baseline , week 60 and week 108
Primary	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
Primary	Physical performance-Flexibility	Flexibility - Sit and reach test (Flex-Tester), passive ankle range of motion	Baseline, week 60 and week 108
Primary	Physical performance-Mobility	Mobility - Timed up and go test	Baseline, week 60 and week 108
Primary	Physical performance-Balance and sensory integrity	Balance and sensory integrity - Computerized dynamic posturography (SMART Equi Test)	Baseline, week 60 and week 108

External Links

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