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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04366154
Acronym
COVIPACT
Enrollment
809
Registered
2020-04-28
Start date
2020-04-15
Completion date
2021-05-31
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, COVID-19

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

Interventions

OTHERQuestionnaire

delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 hemopathyup to 6 monthsProportion 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 hemopathyup to 6 monthsProportion 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 hemopathyup to 6 monthsProportion 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 hemopathyup to 6 monthsProportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Secondary

MeasureTime frameDescription
Evaluate the perceived stress on cancer patients treated in unit day of hospitalup to 12 monthsScore of questionnaires of Perceived Stress Scale \[0-40 points\]
Evaluate the post-traumatic stress on cancer patients treated in unit day of hospitalup to 12 monthsScore of questionnaires of Impact of Event Scale-Revised \[0-88 points\]
Evaluate the sleep disorders on cancer patients treated in unit day of hospitalup to 12 monthsScore of questionnaires of sleep disorders (ISI scale, 0-28 points)
Evaluate the quality of life on cancer patients treated in unit day of hospitalup to 12 monthsScore of questionnaires of quality of life (FACT-G scale)
Evaluate the cognitive complaints on cancer patients treated in unit day of hospitalup to 12 monthsScore 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 monthsScore 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 monthsScore 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 monthsScore 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 monthsScore of questionnaires of feeling of personal effectiveness (0-30 points)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026