Acute Myeloid LeukemiaNCT03310918
A Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
A study testing Palliative Care and Standard Leukemia care in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Palliative Care and Standard Leukemia care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations:
- Newly diagnosed AML
- Relapsed AML
- Primary refractory AML
- The ability to provide informed consent
- The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter
Who cannot join
- Patients not receiving care at MGH
- Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization)
- Patients receiving supportive care alone
- Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures
- Patients already receiving palliative care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy
Read the detailed description
Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia.
This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.
The main purpose of this study is to compare two types of care - standard oncology care and standard oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with AML and MDS undergoing treatment.
The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Palliative Care, Standard Leukemia care
- Keywords
- AML, MDS, Palliative care
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareOther
Specialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family
Standard Leukemia careOther
Standard care per the hospital guideline
| Study group | Role | What they receive |
|---|---|---|
| Collaborative palliative and oncology care | Experimental | * 1st palliative care visit within 30 days of randomization in the outpatient or hospital
* In outpatient setting: once monthly palliative care visits (or video/ or phone)
* During hospital admissions: At least twice weekly palliative care visits Receives: Other: Palliative Care; Other: Standard Leukemia care |
| Standard oncology care | Active comparator | * Palliative care consults only upon request
* Standard oncology care Receives: Other: Standard Leukemia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from documentation of end-of-life care preferences to death
comparison of time from documentation of end-of-life care preferences to death in the electronic health records
Measured: up to 2 years
Secondary outcomes (7)
Rates of documentation of end-of-life care preferences at least one week prior to death.
Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record
Measured: up to 2 years
Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire
comparison of patient-report of discussion end-of-life care preferences between the study arms
Measured: up to 2 years
Compare Rate of hospitalization between the study arms
Compare rates of hospitalizations within 30 days of death between the study arms
Measured: up to 30 days
Rate of hospice utilization and length-of-stay in hospice
Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms
Measured: up to 2 years
compare quality of life
Compare quality of life (FACT-Leuk) at week-12 and longitudinally between the study arms. Score range 0-176 (higher scores indicating better quality of life)
Measured: up to six months
compare symptom burden
Compare symptom burden (ESAS) at week-12 and longitudinally between the study arms. the ESAS score range 0-100 with higher scores indicating worse symptom burden.
Measured: up to six months
compare mood
Compare change in mood (HADS) at week-12, and longitudinally between the study arms. HADS measures depression and anxiety symptoms (subscale range 0-21) higher scores indicating worse mood symptoms
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start31 Oct 2017
- Primary completion1 Apr 2023
- Study completion31 Dec 2026 (estimated)
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 Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310918
- Sponsor's protocol ID
- 17-327
- Other IDs
- ECOR grant 230593
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2017
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.
PubMed 38429079
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
- ClinicalTrials.gov ID
- NCT03310918
- Acronym / sponsor ID
- 17-327
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- AML, MDS, Palliative care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2017 (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.
This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy
Detailed description
Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia.
This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.
The main purpose of this study is to compare two types of care - standard oncology care and standard oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with AML and MDS undergoing treatment.
The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative palliative and oncology care | Experimental | Other: Palliative Care, Other: Standard Leukemia care* 1st palliative care visit within 30 days of randomization in the outpatient or hospital * In outpatient setting: once monthly palliative care visits (or video/ or phone) * During hospital admissions: At least twice weekly palliative care visits |
| Standard oncology care | Active comparator | Other: Standard Leukemia care* Palliative care consults only upon request * Standard oncology care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations:
- The ability to provide informed consent
- The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter
Key exclusion criteria (5 listed)
- Patients not receiving care at MGH
- Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization)
- Patients receiving supportive care alone
- Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures
- Patients already receiving palliative care
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 |
|---|---|---|
| Palliative CareSpecialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family | Other | Collaborative palliative and oncology care |
| Standard Leukemia careStandard care per the hospital guideline | Other | Collaborative palliative and oncology care, Standard oncology care |
Primary outcome
Time from documentation of end-of-life care preferences to death
Time frame: up to 2 years
comparison of time from documentation of end-of-life care preferences to death in the electronic health records
7 secondary outcomes
Rates of documentation of end-of-life care preferences at least one week prior to death.
Time frame: up to 2 years
Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire
Time frame: up to 2 years
Compare Rate of hospitalization between the study arms
Time frame: up to 30 days
Rate of hospice utilization and length-of-stay in hospice
Time frame: up to 2 years
compare quality of life
Time frame: up to six months
compare symptom burden
Time frame: up to six months
compare mood
Time frame: up to six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 38429079Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.
- 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.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care and Standard Leukemia care in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Massachusetts General Hospital at 2 sites in United States.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time from documentation of end-of-life care preferences to death (time frame: up to 2 years). 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 NCT03310918, 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 6 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.