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Clinical Trials/NCT04351139
NCT04351139
Completed
N/A

Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

Hospices Civils de Lyon3 sites in 1 country205 target enrollmentMay 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gynecologic Cancer
Sponsor
Hospices Civils de Lyon
Enrollment
205
Locations
3
Primary Endpoint
percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2020
End Date
November 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)

Time Frame: Day O

modification of the planned therapeutic management

Study Sites (3)

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