Acute Myeloid LeukemiaNCT02975869
A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
A study testing Standard Leukemia Care and Palliative Care in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Standard Leukemia Care and Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2017to 1 Jan 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with high-risk AML, defined as:
- Newly diagnosed patients with AML ≥ 60 years of age
- Newly diagnosed AML with antecedent hematologic disorder
- Newly diagnosed therapy-related AML
- Relapsed AML
- Primary refractory AML
Who cannot join
- Patients already receiving palliative care
- Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
- A diagnosis of acute promyelocytic leukemia (APML)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts general Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
University of Pennsylvania
Philadelphia, Pennsylvania, 16802
About this study
Official title: Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
Read the detailed description
The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML undergoing treatment.
The investigators aim to find out whether introducing patients and families undergoing AML treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Standard Leukemia Care, Palliative Care
- Keywords
- Leukemia, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Leukemia CareOther
Palliative CareOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Leukemia Care | Active comparator | Standard Leukemia care Receives: Other: Standard Leukemia Care |
| Collaborative Palliative and Oncology Care | Experimental | Collaborative care from Palliative Care and Leukemia will be given Receives: Other: Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Measured: 2 weeks
Secondary outcomes (8)
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
Measured: up to 6 months
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress.
Measured: up to 6 months
Compare Symptom Burden (as per ESAS) Between Study Arms.
We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden.
Measured: up to 6 months
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms
Measured: up to 6 months
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
We will compare patient-reported discussing their EOL care preferences between the two groups
Measured: up to 6 months
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
to compare rates of chemotherapy administration near the end of life between the two arms
Measured: up to 6 months
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
to compare rates of hospitalizations within the last week of life between the study arms
Measured: up to 6 months
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Sep 2019
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- 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
- NCT02975869
- Sponsor's protocol ID
- 16-439
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2016
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 38429079El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb JA, Jackson VA, Campbell TC, O'Connor N, Luger SM, Gafford E, Gustin J, Bhatnagar B, Walker AR, Fathi AT, Brunner AM, Hobbs GS, Nicholson S, Davis D, Addis H, Vaughn D, Horick N, Greer JA, Temel JS. Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2021 Feb 1;7(2):238-245. doi: 10.1001/jamaoncol.2020.6343.
PubMed 33331857
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02975869
- Acronym / sponsor ID
- 16-439
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 29 Nov 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.
This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
Detailed description
The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML undergoing treatment.
The investigators aim to find out whether introducing patients and families undergoing AML treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Leukemia Care | Active comparator | Other: Standard Leukemia CareStandard Leukemia care |
| Collaborative Palliative and Oncology Care | Experimental | Other: Palliative CareCollaborative care from Palliative Care and Leukemia will be given |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized patients with high-risk AML, defined as:
- Newly diagnosed patients with AML ≥ 60 years of age
- Newly diagnosed AML with antecedent hematologic disorder
- Newly diagnosed therapy-related AML
- Relapsed AML
Key exclusion criteria (3 listed)
- Patients already receiving palliative care
- Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
- A diagnosis of acute promyelocytic leukemia (APML)
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 |
|---|---|---|
| Standard Leukemia Care | Other | Standard Leukemia Care |
| Palliative Care | Other | Collaborative Palliative and Oncology Care |
Primary outcome
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms
Time frame: 2 weeks
We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
8 secondary outcomes
Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms.
Time frame: up to 6 months
Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms
Time frame: up to 6 months
Compare Symptom Burden (as per ESAS) Between Study Arms.
Time frame: up to 6 months
Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms
Time frame: up to 6 months
Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms
Time frame: up to 6 months
Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms
Time frame: up to 6 months
Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms
Time frame: up to 6 months
Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms.
Time frame: up to 6 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 3 Mar 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.
- Derived from this study: PubMed 33331857El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb JA, Jackson VA, Campbell TC, O'Connor N, Luger SM, Gafford E, Gustin J, Bhatnagar B, Walker AR, Fathi AT, Brunner AM, Hobbs GS, Nicholson S, Davis D, Addis H, Vaughn D, Horick N, Greer JA, Temel JS. Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2021 Feb 1;7(2):238-245. doi: 10.1001/jamaoncol.2020.6343.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Leukemia Care and Palliative Care in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 4 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 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms (time frame: 2 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 NCT02975869, which also lists 2 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 3 Mar 2026.