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A Collaborative Palliative and Leukemia Care Model for Patients With AML Receiving Non-Intensive Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03310918
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

Brief 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) receiving non-intensive therapy

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Palliative Care Other: Standard Leukemia care Not Applicable

Detailed Description:

Frequently people undergoing leukemia treatment experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with acute leukemia 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 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 with acute myeloid leukemia (AML) undergoing treatment.

The purpose of this research study is to find out whether introducing patients undergoing treatment for acute myeloid leukemia 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With Acute Myeloid Leukemia Receiving Non-Intensive Therapy
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2024


Arm Intervention/treatment
Experimental: Collaborative palliative and oncology care
  • 1st palliative care visit within 96 hours of randomization in the outpatient or hospital
  • In outpatient setting: At least once weekly for the first 30 days and then at least twice per month thereafter palliative care clinic visits or contact via telephone
  • During hospital admissions to MGH: At least twice weekly palliative care visits
Other: Palliative Care
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

Other: Standard Leukemia care
Standard care per the hospital guideline

Active Comparator: Standard leukemia care
  • Palliative care consults only upon request
  • Standard Leukemia care
Other: Standard Leukemia care
Standard care per the hospital guideline




Primary Outcome Measures :
  1. Time from documentation of end-of-life care preferences to death [ Time Frame: 2 years ]
    comparison of time from documentation of end-of-life care preferences to death in the electronic health records


Secondary Outcome Measures :
  1. Rates of documentation of end-of-life care preferences at least one week prior to death. [ Time Frame: 2 years ]
    Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record

  2. Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire [ Time Frame: 2 years ]
    comparison of patient-report of discussion end-of-life care preferences between the study arms

  3. Compare Rate of hospitalization between the study arms [ Time Frame: up to 30 days ]
    Compare rates of hospitalizations within 3, 7, 14, and 30 days of death between the study arms

  4. Rate of hospice utilization and length-of-stay in hospice [ Time Frame: 2 years ]
    Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms

  5. compare changes in quality of life [ Time Frame: up to one year ]
    Compare change in quality of life (FACT-Leuk) from baseline to week-2, week-4, and longitudinally between the study arms

  6. Compare quality of end-of-life care between the two study arms [ Time Frame: 2 years ]
    compare quality of end-of-life care (FAMCARE) as reported by caregivers between the two study arms

  7. compare changes in symptom burden [ Time Frame: up to 2 years ]
    Compare change in symptom burden (ESAS) from baseline to week-2, week-4, and longitudinally between the study arms

  8. compare changes in mood [ Time Frame: up to 2 years ]
    Compare change in mood (HADS) from baseline to week-2, week-4, and longitudinally between the study arms


Other Outcome Measures:
  1. Rate of chemotherapy administration [ Time Frame: up to 30 days prior to death ]
    compare rate of chemotherapy administration within 3, 7, 14, and 30 days of death between the two study arms

  2. Rates of death in the hospital [ Time Frame: 2 years ]
    compare rates of death in the hospital between the two study arms

  3. caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire [ Time Frame: one month ]
    compare caregiver-reported discussion of end-of-life care preferences between the study arms at one month



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310918


Contacts
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Contact: Areej El-Jawahri, MD 617-726-5765 ael-jawahri@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri, MD    617-726-5765    ael-jawahri@partners.org   
Principal Investigator: Areej El-Jawahri, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital

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Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03310918    
Other Study ID Numbers: 17-327
ECOR grant 230593 ( Other Grant/Funding Number: ECOR )
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms