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

Study Overview
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Brief Summary
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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.

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

Conditions
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Telemedicine

Intervention / Treatment
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* Device: PPG and PROM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app | Device: PPG and PROM<br>* description will follow<br>|

What is the study measuring?
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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 |