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Clinical Trials/NCT04366154
NCT04366154
Unknown
Not Applicable

Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

Centre Francois Baclesse2 sites in 1 country809 target enrollmentApril 15, 2020
ConditionsCOVID-19Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Centre Francois Baclesse
Enrollment
809
Locations
2
Primary Endpoint
To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy
Last Updated
5 years ago

Overview

Brief Summary

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus.

We will also assess the psychological impact of the pandemic in patients but also in caregivers

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
May 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For Patients:
  • Adult patient, treated for a solid or hematological tumor
  • will be treated ou actually treated by oncological treatment carried out at the hospital in day unit of the participating centers: treatment initiated before or during the pandemic with COVID-19
  • For the Caregivers:
  • Medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy

Time Frame: up to 6 months

Proportion of patients with modification of the treatments administered

To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy

Time Frame: up to 6 months

Proportion of patients with change in the rate of treatment administration

To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy

Time Frame: up to 6 months

Proportion of patients with change in the number of cures administered

To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy

Time Frame: up to 6 months

Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Secondary Outcomes

  • Evaluate the perceived stress on cancer patients treated in unit day of hospital(up to 12 months)
  • Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital(up to 12 months)
  • Evaluate the sleep disorders on cancer patients treated in unit day of hospital(up to 12 months)
  • Evaluate the quality of life on cancer patients treated in unit day of hospital(up to 12 months)
  • Evaluate the cognitive complaints on cancer patients treated in unit day of hospital(up to 12 months)
  • Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)(up to 12 months)
  • Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)(up to 12 months)
  • Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)(up to 12 months)
  • Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)(up to 12 months)

Study Sites (2)

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