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

COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Telemedicine
• Intervention / Treatment: Device: PPG and PROM

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine; Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app	Device: PPG and PROM; description will follow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Compliance is defined as wearing time of the in-ear-sensor.	3 months
robustness of the ppg-signal	number and duration of the ppg-signal transmitted	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of correct- and false-positive alerts	definition via comparison of alerts with clinical data	3 months
number of contacts and hospitalization rates	definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data	3 months
infections	detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.	3 months
therapy modifications	dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation	3 months
effect on quality of life	change in minimum 9 points in the EORTC QLQ-C30-questionnaire is evaluated as significant change. In questions 1-28: 28-112 points can be achieved: higher scores are associated with a worse outcome. In questions 29-30:2-14 points can be achieved: higher scores are associated with a better outcome.	3 months
OS; PFS	time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)	3 months
health-related costs	cost-effectiveness analysis	3 months

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Heike Jansen, Dr. med, Technical University of Munich; Study Director: Marion Kiechle, Prof. Dr. med., Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CO-SI-ONKO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No