Neoplasm MalignantEFIQUAVIENCT03775304
Evaluation of End of Life Quality of Care
An observational study of Neoplasm Malignant and Quality of Life, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant, Quality of Life, End of Life Care
- How many people
- 997 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jan 2011to 15 Dec 2015
- 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
- Adult, Older adult
Study population: Patients deceased in 2010, among all patients identified in the DRG database of the 5 participating center with a diagnosis of metastatic cancer, during at least one stay between Oct 1st, 2009 and Dec 31, 2010. 200 patients per study center were randomly selected for the study.
Who may be able to join
- Patients aged ≥ 18,
- diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)
- deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics)
Who cannot join
- diagnosis with non solid tumor (haematology)
- age < 18
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
APHP Hôpital Cochin
Paris
APHP Hôpital Européen Georges Pompidou
Paris
APHP Hôpital Henri Mondor
Paris
Institut Curie
Paris, Île-de-France Region, 75005
Institut Gustave Roussy
Villejuif
About this study
Official title: Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.
The study was approved by the French data protection authority (CNIL) number 611273.
- Conditions
- Neoplasm Malignant, Quality of Life, End of Life Care
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of emergency services within last 30 days before death
Measured: Through study completion, up to 1 year
Secondary outcomes (5)
Patients received chemotherapy in the last 14 days of life
Measured: Through study completion, up to 1 year
Location of death
Measured: Through study completion, up to 1 year
Among patients who died in palliative care unit, those who died within 3 days after admission
Measured: Through study completion, up to 1 year
Admission in intensive care unit within last 30 days before death
Measured: Through study completion, up to 1 year
Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2011
- Primary completion15 Dec 2015
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775304
- Sponsor's protocol ID
- NI10031
- Acronym
- EFIQUAVIE
- Status last verified
- Mar 2017
- First submitted
- 6 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study
- ClinicalTrials.gov ID
- NCT03775304
- Acronym / sponsor ID
- EFIQUAVIE / NI10031
- Conditions
- Neoplasm Malignant, Quality of Life, End of Life Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 13 Dec 2018 (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.
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.
The study was approved by the French data protection authority (CNIL) number 611273.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients deceased in 2010, among all patients identified in the DRG database of the 5 participating center with a diagnosis of metastatic cancer, during at least one stay between Oct 1st, 2009 and Dec 31, 2010. 200 patients per study center were randomly selected for the study.
Key inclusion criteria (3 listed)
- Patients aged ≥ 18,
- diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)
- deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics)
Key exclusion criteria (2 listed)
- diagnosis with non solid tumor (haematology)
- age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Use of emergency services within last 30 days before death
Time frame: Through study completion, up to 1 year
5 secondary outcomes
Patients received chemotherapy in the last 14 days of life
Time frame: Through study completion, up to 1 year
Location of death
Time frame: Through study completion, up to 1 year
Among patients who died in palliative care unit, those who died within 3 days after admission
Time frame: Through study completion, up to 1 year
Admission in intensive care unit within last 30 days before death
Time frame: Through study completion, up to 1 year
Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders
Time frame: Through study completion, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Malignant and Quality of Life, run by Assistance Publique - Hôpitaux de Paris at 5 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of emergency services within last 30 days before death (time frame: Through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2018.