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NCT Number: NCT03310918

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Care

Other

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 care

Other

Standard care per the hospital guideline

Primary outcomes

  1. 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

Secondary outcomes

  1. Rates of documentation of end-of-life care preferences at least one week prior to death.

    Time frame: up to 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: up to 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 30 days of death between the study arms

  4. Rate of hospice utilization and length-of-stay in hospice

    Time frame: up to 2 years

    Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms

  5. compare quality of life

    Time frame: up to six months

    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)

  6. compare symptom burden

    Time frame: up to six months

    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.

  7. compare mood

    Time frame: up to six months

    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

Other outcomes

  1. Rate of chemotherapy administration

    Time frame: up to 30 days prior to death

    compare rate of chemotherapy administration within 30 days of death between the two study arms

  2. Rates of death in the hospital

    Time frame: up to 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

  4. Compare quality of end-of-life care between the two study arms

    Time frame: up to 2 years

    compare quality of end-of-life care (FAMCARE) as reported by caregivers between the two study arms. FAMCARE score range 0-100, higher scores indicate better quality of end-of-life care

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy

Important dates

Study start
2017
Primary completion
2023
Study completion
2026
First posted
Oct 16, 2017
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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