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 Overview
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Brief Summary
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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

Official Title
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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
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COVID-19, Cancer

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | Other: Questionnaire<br>* delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint<br>|
| Caregivers<br> | Other: Questionnaire<br>* delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Proportion of patients with modification of the treatments administered | up to 6 months | 
| 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 | Proportion of patients with change in the rate of treatment administration | up to 6 months | 
| 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 | Proportion of patients with change in the number of cures administered | up to 6 months | 
| 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 | Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses) | up to 6 months | 

Secondary Outcome Measures

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