Clinical trial NCT03310918: A Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
Official title: Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Keywords: AML
MDS
Palliative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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) 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.

Eligibility 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

Primary outcomes:
measure: Time from documentation of end-of-life care preferences to death
timeFrame: up to 2 years
Secondary outcomes:
measure: Rates of documentation of end-of-life care preferences at least one week prior to death.
timeFrame: up to 2 years
measure: Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire
timeFrame: up to 2 years
measure: Compare Rate of hospitalization between the study arms
timeFrame: up to 30 days
measure: Rate of hospice utilization and length-of-stay in hospice
timeFrame: up to 2 years
measure: compare quality of life
timeFrame: up to six months
measure: compare symptom burden
timeFrame: up to six months
measure: compare mood
timeFrame: up to six months
Other outcomes:
measure: Rate of chemotherapy administration
timeFrame: up to 30 days prior to death
measure: Rates of death in the hospital
timeFrame: up to 2 years
measure: caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire
timeFrame: one month
measure: Compare quality of end-of-life care between the two study arms
timeFrame: up to 2 years
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: