Clinical trial NCT04351139: Impact of the COVID-19 Pandemic in Gynecological Oncology
Official title: Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Breast Neoplasm Female
Uterine Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Keywords: Gynecologic Cancer
COVID-19
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 with gynecological cancer (non-metastatic breast cancer, uterus, ovary, cervix, vagina or vulva cancer) and whose therapeutic management was planned during the period of COVID-19 pandemic quarantine.

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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)
timeFrame: Day O
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie, HFME, Hospices Civils de Lyon
city: Lyon
country: France
facility: Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon
city: Pierre-Bénite
country: France
facility: Service Gynécologie, CHLS, Hospices Civils de Lyon
Study officials:
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
name: Géry LAMBLIN
role: PRINCIPAL_INVESTIGATOR
References: