Acute Myeloid LeukemiaPhase 3CALVINCT03800095
Early Palliative Care for Patients With Haematological Malignancies
A Phase 3 study testing Early palliative care integration in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by University Hospital, Clermont-Ferrand at 6 sites in France.
Trial summary
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma
- What is being tested?
- Early palliative care integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesFrance
- Study dates
- 14 Mar 2019to 31 Dec 2023
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients are over 70 years old
- Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.
Who cannot join
- All patients with a curative project (induction chemotherapy ou allogenic transplantation)
- All patients in a terminal palliative status
- Patients who don't speak French,
- Patients not able to read and write
- Patients who don't agree to participate in the protocol
- Patients with psychiatric troubles or cognitive disorders
- Patients under guardianship or curatorship, deprived of freedom or under justice protection.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Centre Hospitalier Métropole Savoie
Chambéry, 73000
Laurent SUTTON
Laurent SUTTON
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 0473754963, drci@chu-clermontferrand.fr
Virginie GUASTELLA
- Recruiting
Chu Limoges
Limoges, 87042
Stéphane MOREAU
Stéphane MOREAU
- Not yet recruiting
Centre Léon Bérard
Lyon, 69008
Anne-Sophie MICHALLET
Anne-Sophie MICHALLET
- Recruiting
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
Denis GUYOTAT
Denis GUYOTAT
- Not yet recruiting
CH Jacques Lacarin
Vichy, 03200
Karine SOULIER-GUERIN
Karine SOULIER-GUERIN
About this study
Official title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
Read the detailed description
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma, Palliative Care
- Being tested
- Early palliative care integration
- Keywords
- Supportive care, Early palliative care, Quality of life, Symptoms management, Haematological malignancy
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Large B-Cell, Diffuse, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care integrationDrug
The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.
| Study group | Role | What they receive |
|---|---|---|
| Conventional haematological care | Experimental | Patients with haematological malignancy Conventional haematological care Receives: Drug: Early palliative care integration |
| Conventional care associated with a monthly consultation | Experimental | Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team Receives: Drug: Early palliative care integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life evaluation: standardized questionnaire
Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188].
Measured: at 6 months
Secondary outcomes (4)
Presence of discomfort symptoms
evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS)
Measured: at Day 0, 3 months, 6 months, 9 months, 12 months
overall survival
Measured: at day 1 : from the randomization until the date of death or until 1 year [study end].
Satisfaction of the care pathwaydesired by the patient
matching between patients desires writing in the medical file and the providing care
Measured: at 12 months or death
cost-effectiveness analysis
The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices).
Measured: at 12 months or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Mar 2019
- Primary completion14 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, Association des foulées de la Haute Lozère, Association CEMSBM, Connaître et Combattre les Myélodysplasies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800095
- Sponsor's protocol ID
- CHU-406
- Other IDs
- 2017-A02515-48
- Acronym
- CALVI
- Status last verified
- Mar 2021
- First submitted
- 13 Sep 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study
- ClinicalTrials.gov ID
- NCT03800095
- Acronym / sponsor ID
- CALVI / CHU-406
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma, Palliative Care
- Keywords
- Supportive care, Early palliative care, Quality of life, Symptoms management, Haematological malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Apicil, Association des foulées de la Haute Lozère, Association CEMSBM, Connaître et Combattre les Myélodysplasies
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 14 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jan 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.
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
Detailed description
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional haematological care | Experimental | Drug: Early palliative care integrationPatients with haematological malignancy Conventional haematological care |
| Conventional care associated with a monthly consultation | Experimental | Drug: Early palliative care integrationPatients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients are over 70 years old
- Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.
Key exclusion criteria (7 listed)
- All patients with a curative project (induction chemotherapy ou allogenic transplantation)
- All patients in a terminal palliative status
- Patients who don't speak French,
- Patients not able to read and write
- Patients who don't agree to participate in the protocol
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 palliative care integrationThe follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team. | Drug | Conventional care associated with a monthly consultation, Conventional haematological care |
Primary outcome
Quality of life evaluation: standardized questionnaire
Time frame: at 6 months
Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188].
4 secondary outcomes
Presence of discomfort symptoms
Time frame: at Day 0, 3 months, 6 months, 9 months, 12 months
overall survival
Time frame: at day 1 : from the randomization until the date of death or until 1 year [study end].
Satisfaction of the care pathwaydesired by the patient
Time frame: at 12 months or death
cost-effectiveness analysis
Time frame: at 12 months or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early palliative care integration in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by University Hospital, Clermont-Ferrand at 6 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 2 inclusion and 7 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lise LACLAUTRE (0473754963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life evaluation: standardized questionnaire (time frame: at 6 months). 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 24 Mar 2021.