Impact of the COVID-19 Pandemic in Gynecological Oncology

NCT ID: NCT04351139

Last Updated: 2021-01-19

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

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-06

Study Completion Date

2020-11-30

Brief Summary

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The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

Detailed Description

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Conditions

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Gynecologic Cancer Breast Neoplasm Female Uterine Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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gynecological cancer

Patients over 18 with gynecological cancer (breast cancer, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned during the period of COVID-19 pandemic during 2020

modification of the planned therapeutic management

Intervention Type OTHER

to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers

control group

Patients over 18 with gynecological cancer (breast, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned outside the period of COVID-19 pandemic, on the end of the year 2019

modification of the planned therapeutic management

Intervention Type OTHER

to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers

Interventions

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modification of the planned therapeutic management

to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women over 18
* gynecological cancer (breast cancer, uterus, ovary, cervix, vagina or vulva cancer)
* therapeutic management planned during quarantine
* person having expressed his non-opposition


* women over 18
* gynecological cancer (breast, uterus, ovary, cervix, vagina or vulva cancer)
* therapeutic management planned on the end of the year 2019
* person having expressed his non-opposition

Exclusion Criteria

* inability to understand the information given
* person deprived of liberty,
* person under guardianship.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Géry LAMBLIN

Role: PRINCIPAL_INVESTIGATOR

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

Locations

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Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, , France

Site Status

Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon

Lyon, , France

Site Status

Service Gynécologie, CHLS, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01036-33

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0346

Identifier Type: -

Identifier Source: org_study_id

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