Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

NCT05342155 | Active Not Recruiting

• 2 other identifiers: HEALTHSHR1R01CA258193-01
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 1

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.

Conditions

Survivorship; Childhood Cancer

Keywords

Health Data

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• I-Chang Huang, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 22, 2022
• Study Start: March 20, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 20, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)