Clinical trial NCT05342155: Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes
Official title: Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Survivorship
Childhood Cancer
Keywords: Health Data
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-04-22
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study

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.

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.

Primary outcomes:
measure: Symptom log
timeFrame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
measure: Euro QoL 5D
timeFrame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
measure: NIH PROMIS 45
timeFrame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
measure: QLACS
timeFrame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
measure: MEPS-US Medical Expenditure Panel Survey
timeFrame: Baseline, week 1, week 5, week 9, week 60 and week 108, timeline for each survivor includes 6 timepoints over 2-year period
measure: Chronic health conditions log
timeFrame: Baseline, week 60 and week 108
measure: Physical performance-Cardiopulmonary fitness
timeFrame: Baseline , week 60 and week 108
measure: Physical performance-Muscular strength and endurance
timeFrame: Baseline, week 60 and week 108
measure: Physical performance-Flexibility
timeFrame: Baseline, week 60 and week 108
measure: Physical performance-Mobility
timeFrame: Baseline, week 60 and week 108
measure: Physical performance-Balance and sensory integrity
timeFrame: Baseline, week 60 and week 108
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: I-Chang Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: