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NCT Number: NCT05342155

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Survivorship Childhood Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. Chronic health conditions log

    Time frame: Baseline, week 60 and week 108

    Log of patient reported chronic health condition status

  7. Physical performance-Cardiopulmonary fitness

    Time frame: Baseline , week 60 and week 108

    Cardiopulmonary fitness - six minute walk and cardiopulmonary exercise testing

  8. 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)

  9. Physical performance-Flexibility

    Time frame: Baseline, week 60 and week 108

    Flexibility - Sit and reach test (Flex-Tester), passive ankle range of motion

  10. Physical performance-Mobility

    Time frame: Baseline, week 60 and week 108

    Mobility - Timed up and go test

  11. Physical performance-Balance and sensory integrity

    Time frame: Baseline, week 60 and week 108

    Balance and sensory integrity - Computerized dynamic posturography (SMART Equi Test)

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 22, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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