Advanced CancerNCT04089306
Integration of Palliative Care in an Oncology and Hematology Unit
An observational study of Advanced Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to May 2020
- 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: Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
Who may be able to join
- Patient aged over 18 years old
- Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
- Died within the 1rst of January 2017 and the 31st of December 2018
- The patient has not expressed an opposition to the use of his medical data during his lifetime.
Who cannot join
- Patient receiving allogeneic stem cell transplant
- Patient expressed during his lifetime an opposition regarding the use of his medical data
Trial locations and contacts
1 site in 1 country.
France1 site
Service D'Hematologie Et D'Oncologie
Strasbourg, 67091
Gabriel MALOUF, MD, PhD, 03 88 11 62 22, gabriel.malouf@chru-strasbourg.fr
Gabriel MALOUF, MD, PhD
About this study
Official title: Integration of Palliative Care in an Oncology and Hematology Unit : a Retrospective Monocentric Study
The main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of palliative care in this population.
Those criterias have been used before in other setting (Earle Criterias, ESMO Recommendations) and The investigators will compare our data to existing publications.
They also hope to see if it is retrospectively possible to assess the probability of death using the Pronopall score. This will help them asses if aggressive end of life care could have been avoided using the Pronopall Score
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, End of Life, Agressiveness of Care, Palliative Care integration
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of palliative care in oncohematology department
Measured: The period from January 1st, 2017 to December 31, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089306
- Sponsor's protocol ID
- 7424
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Palliative Care in an Oncology and Hematology Unit : a Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT04089306
- Acronym / sponsor ID
- 7424
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, End of Life, Agressiveness of Care, Palliative Care integration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 13 Sep 2019 (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 main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of palliative care in this population.
Those criterias have been used before in other setting (Earle Criterias, ESMO Recommendations) and The investigators will compare our data to existing publications.
They also hope to see if it is retrospectively possible to assess the probability of death using the Pronopall score. This will help them asses if aggressive end of life care could have been avoided using the Pronopall Score
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
- Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
Key inclusion criteria (4 listed)
- Patient aged over 18 years old
- Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
- Died within the 1rst of January 2017 and the 31st of December 2018
- The patient has not expressed an opposition to the use of his medical data during his lifetime.
Key exclusion criteria (2 listed)
- Patient receiving allogeneic stem cell transplant
- Patient expressed during his lifetime an opposition regarding the use of his medical data
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
Retrospective study of palliative care in oncohematology department
Time frame: The period from January 1st, 2017 to December 31, 2018 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by University Hospital, Strasbourg, France at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Gabriel MALOUF, MD, PhD (03 88 11 62 22, gabriel.malouf@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of palliative care in oncohematology department (time frame: The period from January 1st, 2017 to December 31, 2018 will be examined). 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 3 Oct 2019.