- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07691008
Wearable Data for Personalized Prognostication in Cancer: A Registry Protocol
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Lee Jones
- Telefonnummer: 626-761-2214
- E-mail: leejones@coh.org
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Observational
Participants have health data collected from their mobile phone for up to 5 years throughout the study.
|
Ikke-interventionel undersøgelse
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of data collection
Tidsramme: 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. |
Up to 8.5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lee Jones, City of Hope Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 260059
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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