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

NCT ID: NCT05043220

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2025-04-30

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.

Detailed Description

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Conditions

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Telemedicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telemedicine

Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app

Group Type EXPERIMENTAL

PPG and PROM

Intervention Type DEVICE

description will follow

Interventions

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PPG and PROM

description will follow

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Heike Jansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heike Jansen, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Marion Kiechle, Prof. Dr. med.

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

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Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CO-SI-ONKO

Identifier Type: -

Identifier Source: org_study_id

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