Clinical trial NCT04366154: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2 populations were recruted in this study : patients with cancer and caregivers

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


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

Primary outcomes:
measure: 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
timeFrame: up to 6 months
measure: 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
timeFrame: up to 6 months
measure: 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
timeFrame: up to 6 months
measure: 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
timeFrame: up to 6 months
Secondary outcomes:
measure: Evaluate the perceived stress on cancer patients treated in unit day of hospital
timeFrame: up to 12 months
measure: Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital
timeFrame: up to 12 months
measure: Evaluate the sleep disorders on cancer patients treated in unit day of hospital
timeFrame: up to 12 months
measure: Evaluate the quality of life on cancer patients treated in unit day of hospital
timeFrame: up to 12 months
measure: Evaluate the cognitive complaints on cancer patients treated in unit day of hospital
timeFrame: up to 12 months
measure: Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
timeFrame: up to 12 months
measure: Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
timeFrame: up to 12 months
measure: Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
timeFrame: up to 12 months
measure: Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
References: