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

Not Applicable

Active, not recruiting

• Conditions: Telemedicine
• Interventions: Device: PPG and PROM

• Registration Number: NCT05043220
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-14
• Study Start: 2021-09-29
• Primary Completion: 2022-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine	PPG and PROM	Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app

Primary Outcome Measures

Name	Time	Method
Compliance	3 months	Compliance is defined as wearing time of the in-ear-sensor.
robustness of the ppg-signal	3 months	number and duration of the ppg-signal transmitted

Secondary Outcome Measures

Name	Time	Method
number of contacts and hospitalization rates	3 months	definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data
infections	3 months	detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.
number of correct- and false-positive alerts	3 months	definition via comparison of alerts with clinical data
health-related costs	3 months	cost-effectiveness analysis
OS; PFS	3 months	time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)
therapy modifications	3 months	dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation
effect on quality of life	3 months	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.

Trial Locations

Locations (1)

Klinikum rechts der Isar, Frauenklinik, Technische Universität München; 🇩🇪 Munich, Germany