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

N/AActive Not RecruitingNCT05043220

Technical University of Munich100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Telemedicine

Interventions

PPG and PROMDEVICE

description will follow

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, Germany

Outcomes

Primary Outcomes

Compliance

Compliance is defined as wearing time of the in-ear-sensor.

Time frame: 3 months

robustness of the ppg-signal

number and duration of the ppg-signal transmitted

Time frame: 3 months

Secondary Outcomes

number of correct- and false-positive alerts

definition via comparison of alerts with clinical data

Time frame: 3 months

number of contacts and hospitalization rates

definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data

Time frame: 3 months

infections

detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.

Time frame: 3 months

therapy modifications

dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation

Time frame: 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.

Time frame: 3 months

OS; PFS

Data from ClinicalTrials.gov

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