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

Cancer Clinical Trial

— COVIPACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04366154
• Other study ID #: 2020-A00879-30
• Status: Active, not recruiting
• Start date: April 15, 2020
• Est. completion date: May 2021

Study information

• Verified date: December 2020
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 809
• Est. completion date: May 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• COVID-19
• Infection

Intervention

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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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