Impact of the COVID-19 Pandemic in Gynecological Oncology
- Conditions
- Breast Neoplasm FemaleOvarian NeoplasmsGynecologic CancerUterine Cervical NeoplasmsUterine NeoplasmsVulvar NeoplasmsVaginal Neoplasms
- Interventions
- Other: modification of the planned therapeutic management
- Registration Number
- NCT04351139
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 205
- 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
- inability to understand the information given
- person deprived of liberty,
- person under guardianship.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description gynecological cancer modification of the planned therapeutic management 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 control group modification of the planned therapeutic management 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
- Primary Outcome Measures
Name Time Method percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy) Day O modification of the planned therapeutic management
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Service de Gynécologie, HFME, Hospices Civils de Lyon
🇫🇷Bron, France
Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon
🇫🇷Lyon, France
Service Gynécologie, CHLS, Hospices Civils de Lyon
🇫🇷Pierre-Bénite, France