COVID-19COVIPACTNCT04366154
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
An observational study of COVID-19 and Cancer, run by Centre Francois Baclesse at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Questionnaire
- How many people
- 809 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2020to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2 populations were recruted in this study : patients with cancer and caregivers
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Questionnaire | |
| Caregivers | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Proportion of patients with change in the rate of treatment administration
Measured: 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
Proportion of patients with change in the number of cures administered
Measured: 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
Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)
Measured: up to 6 months
Secondary outcomes (9)
Evaluate the perceived stress on cancer patients treated in unit day of hospital
Score of questionnaires of Perceived Stress Scale [0-40 points]
Measured: up to 12 months
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]
Measured: up to 12 months
Evaluate the sleep disorders on cancer patients treated in unit day of hospital
Score of questionnaires of sleep disorders (ISI scale, 0-28 points)
Measured: up to 12 months
Evaluate the quality of life on cancer patients treated in unit day of hospital
Score of questionnaires of quality of life (FACT-G scale)
Measured: up to 12 months
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)
Measured: up to 12 months
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]
Measured: up to 12 months
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]
Measured: up to 12 months
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)
Measured: up to 12 months
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)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start15 Apr 2020
- Primary completion15 Jul 2020
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366154
- Sponsor's protocol ID
- 2020-A00879-30
- Acronym
- COVIPACT
- Status last verified
- Dec 2020
- First submitted
- 16 Apr 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherifi F, Gernier F, Jardin F, Lefevre-Arbogast S, Bastien E, Lequesne J, Rigal O, Quilan F, Clarisse B, Grellard JM, Binarelli G, Fernette M, Lange M, Richard D, Morel A, Griffon B, Pepin LF, Leconte A, Faveyrial A, Leheurteur M, Beauplet B, Joly F. Post-traumatic stress disorder symptoms and quality of life among older patients with cancer during the COVID-19 pandemic. J Geriatr Oncol. 2023 Nov;14(8):101634. doi: 10.1016/j.jgo.2023.101634. Epub 2023 Sep 25.
PubMed 37757587Bastien E, Lefevre-Arbogast S, Lequesne J, Gernier F, Cherifi F, Rigal O, Guittet L, Grellard JM, Binarelli G, Lange M, Fernette M, Tron L, Morel A, Richard D, Griffon B, Leconte A, Quilan F, Pepin LF, Jardin F, Leheurteur M, Faveyrial A, Clarisse B, Joly F. Posttraumatic Stress Symptoms in Patients With Cancer During the COVID-19 Pandemic: A One-Year Longitudinal Study. J Natl Compr Canc Netw. 2023 Feb 22;21(3):265-272.e7. doi: 10.6004/jnccn.2023.7085.
PubMed 36812938
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04366154
- Acronym / sponsor ID
- COVIPACT / 2020-A00879-30
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 809 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionnaire |
| Caregivers | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2 populations were recruted in this study : patients with cancer and caregivers
Key inclusion criteria (5 listed)
- 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
- Medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairedelivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint | Other | Caregivers, Patients |
Primary outcome
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
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
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
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)
9 secondary outcomes
Evaluate the perceived stress on cancer patients treated in unit day of hospital
Time frame: up to 12 months
Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital
Time frame: up to 12 months
Evaluate the sleep disorders on cancer patients treated in unit day of hospital
Time frame: up to 12 months
Evaluate the quality of life on cancer patients treated in unit day of hospital
Time frame: up to 12 months
Evaluate the cognitive complaints on cancer patients treated in unit day of hospital
Time frame: up to 12 months
Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Time frame: up to 12 months
Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Time frame: up to 12 months
Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Time frame: up to 12 months
Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 37757587Cherifi F, Gernier F, Jardin F, Lefevre-Arbogast S, Bastien E, Lequesne J, Rigal O, Quilan F, Clarisse B, Grellard JM, Binarelli G, Fernette M, Lange M, Richard D, Morel A, Griffon B, Pepin LF, Leconte A, Faveyrial A, Leheurteur M, Beauplet B, Joly F. Post-traumatic stress disorder symptoms and quality of life among older patients with cancer during the COVID-19 pandemic. J Geriatr Oncol. 2023 Nov;14(8):101634. doi: 10.1016/j.jgo.2023.101634. Epub 2023 Sep 25.
- Derived from this study: PubMed 36812938Bastien E, Lefevre-Arbogast S, Lequesne J, Gernier F, Cherifi F, Rigal O, Guittet L, Grellard JM, Binarelli G, Lange M, Fernette M, Tron L, Morel A, Richard D, Griffon B, Leconte A, Quilan F, Pepin LF, Jardin F, Leheurteur M, Faveyrial A, Clarisse B, Joly F. Posttraumatic Stress Symptoms in Patients With Cancer During the COVID-19 Pandemic: A One-Year Longitudinal Study. J Natl Compr Canc Netw. 2023 Feb 22;21(3):265-272.e7. doi: 10.6004/jnccn.2023.7085.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Cancer, run by Centre Francois Baclesse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.