Incurable DiseaseMAHO2NCT02906462
Impact of an Early Palliative Approach
A study testing Early consideration of vulnerability and Usual practices in people with Incurable Disease, run by Hopital Foch at 23 sites in France.
Trial summary
In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incurable Disease
- What is being tested?
- Early consideration of vulnerability and Usual practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 23 sitesFrance
- Study dates
- Nov 2013to Mar 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient more than 18 years old hospitalized for at least 24h and who's prognosis (survival or quality of life) should lead to a palliative approach
- Patient suffering with at least one of the following vulnerability criteria will be included:
- Evolutive and symptomatic incurable cancer
- Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
- Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
- Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
- Care refusal and/or expressed will to die or repeated request for help to die
- No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline
Who cannot join
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU
Amiens, 80000
Hopital privé Oncologie Médicale
Antony, 92160
Hôpital Privé Medecine interne
Antony, 92160
Hôpital Avicenne
Bobigny, 93000
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Georges Clemenceau
Champcueil, 91750
CHU
Dijon, 21000
Centre Hospitalier
Épernay, 51200
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU
Lille, 59000
Hopital Lariboisiere Medecine interne
Paris, 75010
Groupe Hospitalier Paris - Saint-Joseph
Paris, 75014
Hopital Cochin Gastro-Enterologie
Paris, 75014
Centre Hospitalier Universitaire
Poitiers, 86000
Centre Hospitalier
Roubaix, 59100
Centre Hospitalier de Soissons
Soissons, 02200
Hiopital Foch Néphrologie
Suresnes, 92150
Hopital Foch Cardiologie
Suresnes, 92150
Hopital Foch Chirurgie Urologique
Suresnes, 92150
Hopital Foch Médecine Interne
Suresnes, 92150
Hopital Foch Neurochirurgie
Suresnes, 92150
Hopîtal Foch Urgences
Suresnes, 92150
CH
Valenciennes, 59300
About this study
Official title: Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"
In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Read the detailed description
In 2003, MAHO study evaluated the way 3793 patients died en 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Principal Objective: To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
Primary endpoint: Rate of withdraw/withhold of treatment in each group.
Secondary objectives: To evaluate the impact of early recognition of patients' vulnerability on death conditions ; to evaluate this strategy impact according to unit type on length of stay, palliative strategy modalities and caregivers' satisfaction.
Secondary endpoints: Rate of therapeutic involvement reflections ; rate of death following withholding or withdrawing of treatments ; traceability of the level of therapeutic involvement process ; Rate of patients deceased with their relatives next to them ; rate of patients deceased with comfort treatment ; rate of palliative care consultation before death ; rate of asks for euthanasia ; Doctor and nurse's perception of quality of support and death process of the patient
Methods: Prospective, controlled, cluster randomized study of routine care 2 groups:
- Group A: standard care and practice after 1 day of training
- Group B: 1 day of training, learning the vulnerability criteria that should induce early thinking about level of therapeutic involvement; web accessed forms will be available to help collegial process, withhold and withdraw decisions traceability, using legal requirements Number of patients to include: To detect a 20% absolute difference in palliative strategy used (30 to 50%), we determined that 5040 patients would provide a power of 80% with the use of a two-sided alpha level of 0.05. Sequential analysis is planned in order to early stop the study in case of efficacy or futility (minimal inclusion: 500 patients)
Inclusion criteria:
All patients hospitalized with at least one of the following vulnerability criteria will be included:
- Evolutive and symptomatic incurable cancer
- Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
- Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
- Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
- Care refusal and/or expressed will to die or repeated request for help to die
Exclusion criteria:
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
Duration: 37 months (28 inclusion months for each center and a follow-up to hospital discharge, death or 9 months if the patient is still hospitalized).
Number of participating centers: 20 centers (28 services) were selected and recruit after training program among centers that did not used a formalized process to initiate level of therapeutic involvement reflection.
- Conditions
- Incurable Disease
- Being tested
- Early consideration of vulnerability, Usual practices
- Keywords
- Leonetti French law, Palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early consideration of vulnerabilityOther
One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti
Usual practicesOther
the centres applies their usual practices
| Study group | Role | What they receive |
|---|---|---|
| Usual Practices | Other | Usual Practices Receives: Other: Usual practices |
| Early consideration of vulnerability | Other | Strategy promoting early consideration of patients' vulnerability Receives: Other: Early consideration of vulnerability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of withdraw/withhold of treatment in each group
To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
Measured: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Secondary outcomes (4)
Death conditions
rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist.
rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist.
Measured: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on length of stay
total length of stay in the hospital
Measured: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Palliative strategy modalities
rate of reflections on level of therapeutic involvement
Measured: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on caregivers' satisfaction
Physician and nurses' perceptions about care management and conditions of death, caregivers interview with a psychologist
Measured: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2013
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Investigator's decision (departure from institution)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Incurable DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Ferrand, MD, Principal investigator, e.ferrand@hopital-foch.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906462
- Sponsor's protocol ID
- 2013/99
- Other IDs
- 2012-A00444-39
- Acronym
- MAHO2
- Status last verified
- May 2019
- First submitted
- 17 Feb 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. doi: 10.1097/00003246-200112000-00017. No abstract available.
PubMed 11801837Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.
PubMed 18443263Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.
PubMed 11197395Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. doi: 10.1164/rccm.200207-752OC. Epub 2003 Jan 24.
PubMed 12738597Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. doi: 10.1007/s00134-006-0292-5. Epub 2006 Aug 2.
PubMed 16896861Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
PubMed 9769276Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.
PubMed 12915432Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Herve C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7. doi: 10.1136/jme.2005.014084.
PubMed 17145904Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139. No abstract available.
PubMed 20818881Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
PubMed 22203758Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
PubMed 23358690
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"
- ClinicalTrials.gov ID
- NCT02906462
- Acronym / sponsor ID
- MAHO2 / 2013/99
- Conditions
- Incurable Disease
- Keywords
- Leonetti French law, Palliative care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator's decision (departure from institution)
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Detailed description
In 2003, MAHO study evaluated the way 3793 patients died en 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Principal Objective: To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
Primary endpoint: Rate of withdraw/withhold of treatment in each group.
Secondary objectives: To evaluate the impact of early recognition of patients' vulnerability on death conditions ; to evaluate this strategy impact according to unit type on length of stay, palliative strategy modalities and caregivers' satisfaction.
Secondary endpoints: Rate of therapeutic involvement reflections ; rate of death following withholding or withdrawing of treatments ; traceability of the level of therapeutic involvement process ; Rate of patients deceased with their relatives next to them ; rate of patients deceased with comfort treatment ; rate of palliative care consultation before death ; rate of asks for euthanasia ; Doctor and nurse's perception of quality of support and death process of the patient
Methods: Prospective, controlled, cluster randomized study of routine care 2 groups:
- Group A: standard care and practice after 1 day of training
- Group B: 1 day of training, learning the vulnerability criteria that should induce early thinking about level of therapeutic involvement; web accessed forms will be available to help collegial process, withhold and withdraw decisions traceability, using legal requirements Number of patients to include: To detect a 20% absolute difference in palliative strategy used (30 to 50%), we determined that 5040 patients would provide a power of 80% with the use of a two-sided alpha level of 0.05. Sequential analysis is planned in order to early stop the study in case of efficacy or futility (minimal inclusion: 500 patients)
Inclusion criteria:
All patients hospitalized with at least one of the following vulnerability criteria will be included:
- Evolutive and symptomatic incurable cancer
- Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
- Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
- Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
- Care refusal and/or expressed will to die or repeated request for help to die
Exclusion criteria:
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
Duration: 37 months (28 inclusion months for each center and a follow-up to hospital discharge, death or 9 months if the patient is still hospitalized).
Number of participating centers: 20 centers (28 services) were selected and recruit after training program among centers that did not used a formalized process to initiate level of therapeutic involvement reflection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Practices | Other | Other: Usual practicesUsual Practices |
| Early consideration of vulnerability | Other | Other: Early consideration of vulnerabilityStrategy promoting early consideration of patients' vulnerability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient more than 18 years old hospitalized for at least 24h and who's prognosis (survival or quality of life) should lead to a palliative approach
- Patient suffering with at least one of the following vulnerability criteria will be included:
- No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline
Key exclusion criteria (4 listed)
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
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 |
|---|---|---|
| Early consideration of vulnerabilityOne day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti | Other | Early consideration of vulnerability |
| Usual practicesthe centres applies their usual practices | Other | Usual Practices |
Primary outcome
Rate of withdraw/withhold of treatment in each group
Time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
4 secondary outcomes
Death conditions
Time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on length of stay
Time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Palliative strategy modalities
Time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on caregivers' satisfaction
Time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Results and safety
The study was stopped early (reason given: Investigator's decision (departure from institution)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Background: PubMed 11801837Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. doi: 10.1097/00003246-200112000-00017. No abstract available.
- Results publication: PubMed 18443263Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.
- Results publication: PubMed 11197395Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.
- Results publication: PubMed 12738597Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. doi: 10.1164/rccm.200207-752OC. Epub 2003 Jan 24.
- Results publication: PubMed 16896861Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. doi: 10.1007/s00134-006-0292-5. Epub 2006 Aug 2.
- Results publication: PubMed 9769276Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
- Results publication: PubMed 12915432Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.
- Results publication: PubMed 17145904Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Herve C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7. doi: 10.1136/jme.2005.014084.
- Results publication: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Results publication: PubMed 20818881Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139. No abstract available.
- Results publication: PubMed 22203758Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
- Results publication: PubMed 23358690Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
- Individual participant dataSharing planned: No
Related trials for Incurable Disease
Not yet recruitingPhase 3
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Hepatocellular Carcinoma
Active, not recruitingPhase 2
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Anxiety, Depression
Recruiting
Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer
Lung Carcinoma, Metastatic Lung Carcinoma
Active, not recruitingPhase 2
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
IPMN, IPMN, Pancreatic
Active, not recruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers
Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
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.
Edouard Ferrand, MD principal investigator
e.ferrand@hopital-foch.org
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early consideration of vulnerability and Usual practices in people with Incurable Disease, run by Hopital Foch at 23 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 was stopped early (reason given: Investigator's decision (departure from institution)). 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?
Rate of withdraw/withhold of treatment in each group (time frame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital). 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 NCT02906462, which also lists 12 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 17 May 2019.