Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy (CO-SI-ONKO)

Technical University of Munich

Status: Active, not recruiting

Conditions: Telemedicine

Treatments: Device: PPG and PROM

Study type: Interventional

Funder types: Other

Identifiers

NCT05043220

CO-SI-ONKO

Details and patient eligibility

About

We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gynecological cancer
• indication for systemic cancer therapy
• patients who are legally competent and able to understand and follow instructions of the study staff
• present informed consent

Exclusion criteria

• no use if internet or applications
• persons who are in a dependency or employment relationship with the study center
• positive proof of COVID-19
• affection of the external auditory canal

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Telemedicine

Experimental group

Description:

Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app

Treatment:

Device: PPG and PROM