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)
11. desember 2020 oppdatert av: Centre Francois Baclesse
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
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
809
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Caen, Frankrike
- Centre François Baclesse
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Rouen, Frankrike
- Centre Henri Becquerel
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
2 populations were recruted in this study : patients with cancer and caregivers
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Omsorgspersoner
|
delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
|
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Pasienter
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delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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
Tidsramme: up to 6 months
|
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
Tidsramme: up to 6 months
|
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
Tidsramme: up to 6 months
|
Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)
|
up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
|
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]
|
up to 12 months
|
|
Evaluate the sleep disorders on cancer patients treated in unit day of hospital
Tidsramme: up to 12 months
|
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
Tidsramme: up to 12 months
|
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
Tidsramme: up to 12 months
|
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)
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]
|
up to 12 months
|
|
Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Tidsramme: up to 12 months
|
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)
Tidsramme: up to 12 months
|
Score of questionnaires of feeling of personal effectiveness (0-30 points)
|
up to 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. april 2020
Primær fullføring (Faktiske)
15. juli 2020
Studiet fullført (Forventet)
1. mai 2021
Datoer for studieregistrering
Først innsendt
16. april 2020
Først innsendt som oppfylte QC-kriteriene
27. april 2020
Først lagt ut (Faktiske)
28. april 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020-A00879-30
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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