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

• Conditions: COVID-19; Cancer
• Interventions: Other: Questionnaire

• Registration Number: NCT04366154
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Primary Completion: 2020-07-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 809

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Questionnaire	-
Caregivers	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
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	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	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	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	up to 6 months	Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Secondary Outcome Measures

Name	Time	Method
Evaluate the perceived stress on cancer patients treated in unit day of hospital	up to 12 months	Score of questionnaires of Perceived Stress Scale \[0-40 points\]
Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital	up to 12 months	Score of questionnaires of Impact of Event Scale-Revised \[0-88 points\]
Evaluate the sleep disorders on cancer patients treated in unit day of hospital	up to 12 months	Score of questionnaires of sleep disorders (ISI scale, 0-28 points)
Evaluate the quality of life on cancer patients treated in unit day of hospital	up to 12 months	Score of questionnaires of quality of life (FACT-G scale)
Evaluate the cognitive complaints on cancer patients treated in unit day of hospital	up to 12 months	Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)
Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)	up to 12 months	Score of questionnaires of Perceived Stress Scale \[0-40 points\]
Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)	up to 12 months	Score of questionnaires of Impact of Event Scale-Revised \[0-88 points\]
Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)	up to 12 months	Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)
Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)	up to 12 months	Score of questionnaires of feeling of personal effectiveness (0-30 points)

Trial Locations

Locations (2)

Centre François Baclesse; 🇫🇷 Caen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France