- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 (COVIPACT)
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
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Caen, Frankrig
- Centre Francois Baclesse
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Rouen, Frankrig
- Centre Henri Becquerel
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Omsorgspersoner
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delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
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Patienter
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delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: up to 6 months
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Proportion of patients with modification of the treatments administered
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up to 6 months
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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
Tidsramme: up to 6 months
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Proportion of patients with change in the rate of treatment administration
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up to 6 months
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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
Tidsramme: up to 6 months
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Proportion of patients with change in the number of cures administered
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up to 6 months
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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
Tidsramme: up to 6 months
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Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)
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up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluate the perceived stress on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
|
Score of questionnaires of Perceived Stress Scale [0-40 points]
|
up to 12 months
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Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
|
Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
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up to 12 months
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Evaluate the sleep disorders on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
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Score of questionnaires of sleep disorders (ISI scale, 0-28 points)
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up to 12 months
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Evaluate the quality of life on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
|
Score of questionnaires of quality of life (FACT-G scale)
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up to 12 months
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Evaluate the cognitive complaints on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
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Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)
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up to 12 months
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Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Tidsramme: up to 12 months
|
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)
Tidsramme: up to 12 months
|
Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
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up to 12 months
|
Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Tidsramme: up to 12 months
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Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)
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up to 12 months
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Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Tidsramme: up to 12 months
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Score of questionnaires of feeling of personal effectiveness (0-30 points)
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up to 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020-A00879-30
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med COVID-19
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