Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy

Telemedicine Clinical Trial

— CO-SI-ONKO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05043220
• Other study ID #: CO-SI-ONKO
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telemedicine

Intervention

Device:
• PPG and PROM
description will follow

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Frauenklinik, Technische Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Compliance is defined as wearing time of the in-ear-sensor.	3 months
Primary	robustness of the ppg-signal	number and duration of the ppg-signal transmitted	3 months
Secondary	number of correct- and false-positive alerts	definition via comparison of alerts with clinical data	3 months
Secondary	number of contacts and hospitalization rates	definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data	3 months
Secondary	infections	detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.	3 months
Secondary	therapy modifications	dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation	3 months
Secondary	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
Secondary	OS; PFS	time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)	3 months
Secondary	health-related costs	cost-effectiveness analysis	3 months