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A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02975869
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Duke University
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 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.

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Standard Leukemia Care
Standard Leukemia care
Other: Standard Leukemia Care
Experimental: Collaborative Palliative and Oncology Care
Collaborative care from Palliative Care and Leukemia will be given
Other: Palliative Care



Primary Outcome Measures :
  1. Comparison Of The Change In Patients' FACT-Leukemia Score From Baseline To Week-2 Between Study Arms [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Compare Change In FACT-Leukemia Scores From Baseline To Months 1, 3, And 6, And Longitudinally Between The Study Arms. [ Time Frame: 6 months ]
  2. Compare Rates of Patients' Depressive Symptoms (as per HADS), and Major Depressive Syndrome (as per PHQ-9) at Baseline, Week-2, Months 1, 3, and 6, and Longitudinally Between the Two Arms [ Time Frame: 6 Months ]
  3. Compare Change In Patients' Fatigue Scores (as per FACT-fatigue) From Baseline To Week-2, Baseline To Months 1, 3, And 6, And Longitudinally Between Study Arms. [ Time Frame: 6 months ]
  4. Compare Symptom Burden (as per ESAS) At Baseline, Week-2, Months 1, 3, And 6, And Longitudinally Between Study Arms. [ Time Frame: 6 months ]
  5. Compare Rates Of Patient-Reported PTSD (as per PCL) At Week-2, Months 1, 3, And 6, And Longitudinally Between Study Arms. [ Time Frame: 6 months ]
  6. Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms [ Time Frame: 6 months ]
  7. Compare Rates Of Documentation Of EOL Care Preferences (i.e. code status yes documented vs. no) In The Electronic Health Record Between The Two Study Arms Within 30 Days Of Death [ Time Frame: 6 months ]
  8. Compare Rates Of Chemotherapy Administration Within 3, 7, 14, And 30 Days Of Death Between The Two Study Arms [ Time Frame: 6 months ]
  9. Compare Rates Of Hospitalizations Within 3, 7, 14, And 30 Days Of Death Between The Study Arms [ Time Frame: 6 months ]
  10. Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms. [ Time Frame: 6 months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients already receiving palliative care
  • Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
  • A diagnosis of acute promyelocytic leukemia (APML)

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): NCT02975869


Contacts
Contact: Areej El-Jawahri, MD 617-643-4003

Locations
United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri, MD    617-643-4003      
Principal Investigator: Areej El-Jawahri, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Thomas LeBlanc, MD    919-684-8964      
Principal Investigator: Thomas LeBlanc, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 16802
Contact: Selina Luger, MD    800-789-7366    selina.luger@uphs.upenn.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Duke University
Investigators
Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital

Responsible Party: El-Jawahri, Areej,M.D., MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02975869     History of Changes
Other Study ID Numbers: 16-439
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Leukemia
Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms