Impact of the COVID-19 Pandemic in Gynecological Oncology (COVID-GYN)

Civil Hospices of Lyon

Status: Completed

Conditions: Uterine Cervical Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Vulvar Neoplasms; Breast Neoplasm Female; Gynecologic Cancer; Vaginal Neoplasms

Treatments: Other: modification of the planned therapeutic management

Study type: Observational

Funder types: Other

Identifiers

NCT04351139

69HCL20_0346

2020-A01036-33 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Inclusion Criteria of control group :

• 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.

Trial design

205 participants in 2 patient groups

gynecological cancer

Description:

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

Treatment:

Other: modification of the planned therapeutic management

control group

Description:

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

Treatment:

Other: modification of the planned therapeutic management