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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 (COVIPACT)

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ClinicalTrials.gov Identifier: NCT04366154
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

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


Condition or disease Intervention/treatment
COVID-19 Cancer Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort Intervention/treatment
Patients Other: Questionnaire
delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint

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




Primary Outcome Measures :
  1. 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 [ Time Frame: up to 6 months ]
    Proportion of patients with modification of the treatments administered

  2. 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 [ Time Frame: up to 6 months ]
    Proportion of patients with change in the rate of treatment administration

  3. 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 [ Time Frame: up to 6 months ]
    Proportion of patients with change in the number of cures administered

  4. 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 [ Time Frame: up to 6 months ]
    Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)


Secondary Outcome Measures :
  1. Evaluate the perceived stress on cancer patients treated in unit day of hospital [ Time Frame: up to 6 months ]
    Score of questionnaires of Perceived Stress Scale [0-40 points]

  2. Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital [ Time Frame: up to 6 months ]
    Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

  3. Evaluate the sleep disorders on cancer patients treated in unit day of hospital [ Time Frame: up to 6 months ]
    Score of questionnaires of sleep disorders (ISI scale, 0-28 points)

  4. Evaluate the quality of life on cancer patients treated in unit day of hospital [ Time Frame: up to 6 months ]
    Score of questionnaires of quality of life (FACT-G scale)

  5. Evaluate the cognitive complaints on cancer patients treated in unit day of hospital [ Time Frame: up to 6 months ]
    Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)

  6. Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) [ Time Frame: up to 3 months ]
    Score of questionnaires of Perceived Stress Scale [0-40 points]

  7. Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) [ Time Frame: up to 3 months ]
    Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

  8. Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) [ Time Frame: up to 3 months ]
    Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)

  9. Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) [ Time Frame: up to 3 months ]
    Score of questionnaires of feeling of personal effectiveness (0-30 points)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
2 populations were recruted in this study : patients with cancer and caregivers
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366154


Contacts
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Contact: Audrey FAVEYRIAL, MD 0231455050 a.faveyrial@baclesse.unicancer.fr
Contact: Florence JOLY, PhD 0231455002 f.joly@baclesse.unicancer.fr

Locations
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France
Centre François Baclesse Recruiting
Caen, France
Contact: Audrey FAVEYRIAL, MD    0231455050    a.faveyrial@baclesse.unicancer.fr   
Sponsors and Collaborators
Centre Francois Baclesse
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT04366154    
Other Study ID Numbers: 2020-A00879-30
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection