Acute Leukaemia in RelapsePablo HematoNCT02631811
Early Palliative Care in Patient With Acute Leukaemia
A study testing Supportive /palliative care intervention in people with Acute Leukaemia in Relapse, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukaemia in Relapse
- What is being tested?
- Supportive /palliative care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2016to 1 Oct 2020
- 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
- > 18 years old
- acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion.
- Patients in whom a curative strategy (transplant) is not considered.
- patients older that 75 years at the diagnosis
- informed signed consent
Who cannot join
- unable to answer the questionnaire
- psychiatric disorders other than depression
- persons under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .
- Conditions
- Acute Leukaemia in Relapse
- Being tested
- Supportive /palliative care intervention
- Keywords
- acute leukaemia, supportive / palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive /palliative care interventionOther
patients will be seen by palliative care team at least once a month until the 12th week, more if needed. The symptom and suffering will be assessed by a multidisciplinary palliative specialist team of physician, nurse and psychologist. Physical, psychological, social and existential suffering will be addressed.
| Study group | Role | What they receive |
|---|---|---|
| Supportive /palliative care intervention | Experimental | patients will be supported by a multidisciplinary palliative specialist team Receives: Other: Supportive /palliative care intervention |
| usual medical follow up | No intervention | patients will be supported by the support care team if asked by the oncologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesure of quality of life
Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups
Measured: 12 weeks
Secondary outcomes (5)
measure of symptoms intensity
Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups
Measured: 12 weeks
measure of depression
score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups
Measured: 12 weeks
measure of anxiety
score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups
Measured: 12 weeks
measure of the quality of the end of life
Within the last month of life, several parameters will be studied to evaluate the quality of the end of life like number of admission in emergency unit.
Measured: up to 9 months
overall survival
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start9 Feb 2016
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Leukaemia in RelapseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631811
- Sponsor's protocol ID
- 69HCL15_0305
- Acronym
- Pablo Hemato
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2015
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ledoux M, Rhondali W, Lafumas V, Berthiller J, Teissere M, Piegay C, Couray-Targe S, Schott AM, Bruera E, Filbet M. Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. BMJ Support Palliat Care. 2019 Mar;9(1):e16. doi: 10.1136/bmjspcare-2014-000791. Epub 2015 Sep 23.
PubMed 26399699
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.
- ClinicalTrials.gov ID
- NCT02631811
- Acronym / sponsor ID
- Pablo Hemato / 69HCL15_0305
- Conditions
- Acute Leukaemia in Relapse
- Keywords
- acute leukaemia, supportive / palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Dec 2015 (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.
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive /palliative care intervention | Experimental | Other: Supportive /palliative care interventionpatients will be supported by a multidisciplinary palliative specialist team |
| usual medical follow up | No intervention | –patients will be supported by the support care team if asked by the oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years old
- acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion.
- Patients in whom a curative strategy (transplant) is not considered.
- patients older that 75 years at the diagnosis
- informed signed consent
Key exclusion criteria (3 listed)
- unable to answer the questionnaire
- psychiatric disorders other than depression
- persons under guardianship
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 |
|---|---|---|
| Supportive /palliative care interventionpatients will be seen by palliative care team at least once a month until the 12th week, more if needed. The symptom and suffering will be assessed by a multidisciplinary palliative specialist team of physician, nurse and psychologist. Physical, psychological, social and existential suffering will be addressed. | Other | Supportive /palliative care intervention |
Primary outcome
mesure of quality of life
Time frame: 12 weeks
Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups
5 secondary outcomes
measure of symptoms intensity
Time frame: 12 weeks
measure of depression
Time frame: 12 weeks
measure of anxiety
Time frame: 12 weeks
measure of the quality of the end of life
Time frame: up to 9 months
overall survival
Time frame: 9 months
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 15 Sep 2025.
- Results publication: PubMed 26399699Ledoux M, Rhondali W, Lafumas V, Berthiller J, Teissere M, Piegay C, Couray-Targe S, Schott AM, Bruera E, Filbet M. Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. BMJ Support Palliat Care. 2019 Mar;9(1):e16. doi: 10.1136/bmjspcare-2014-000791. Epub 2015 Sep 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive /palliative care intervention in people with Acute Leukaemia in Relapse, run by Hospices Civils de Lyon 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 5 inclusion and 3 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 15 Sep 2025. 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?
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?
mesure of quality of life (time frame: 12 weeks). 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 NCT02631811, which also lists 1 linked publication.
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 15 Sep 2025.