Wearable Data for Personalized Prognostication in Cancer: A Registry Protocol

This study will have two distinct stages. Stage 1 will examine and refine the utility and feasibility of the Apple Health-Epic platform in a small, convenience-driven patient cohort to ensure platform robustness and patient feasibility prior to initiating larger recruitment efforts in Stage 2. The objectives of Stage 2 will be to conduct enterprise-wide enrollment to build a large registry database permitting investigation of future specific questions that will be addressed in subsequent retrospective research protocols linked to this registry protocol.

• Non-Interventional Study (Other), also known as Non-Interventional Observational Study, non-interventional study, Noninterventional (Observational) Study: Non-Interventional Study

Primary outcomes

• Feasibility of data collection [Up to 8.5 years]: The proportion of participants for whom a successful data connection is established between their Apple Health data and the study registry will be quantified". Then for each variable captured by Apple Health, we will quantify the following feasibility metrics for data collection, evaluated separately for the retrospective (up to 8 years) and prospective (up to 5 years) data periods: For each subject, the total amount of retrospective (and prospective) HealthKit data available per patient in days and months will be calculated. For each subject, the number of days per week that a variable is available will be estimated and summarized by the average and standard deviation across weeks (or months). For both 1-2, the metrics will be calculated when pooling all available data, and separately for windows of 6 months. We will examine histograms and boxplots of the distributions across the cohort.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Age: ≥ 18 years
* Has Apple Health app on personal device with valid iOS operating software (i.e., iOS 15.0 or higher)
* Has a registered MyChart/MyCityofHope account (or be willing to register for one) and the app downloaded onto the personal device that also contains the Apple Health app with their data
* Ability to read and understand English to review MyChart/MyCityofHope on-screen instructions to sync and share Apple Health data
* Meets one of the below criteria:
* Any patient at City of Hope who had and/or has a cancer-related visit (e.g., high risk, newly diagnosed, receiving treatment, active follow-up, survivorship etc.)
* City of Hope employee

Exclusion Criteria:

* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
* City of Hope employees listed on the study roster or who manage employees listed on the study roster

• Lee Jones, Principal investigator, City of Hope Medical Center