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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310918
• Other study ID #: 17-327
• Secondary ID: ECOR grant 23059
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-726-5765
• Email: ael-jawahri[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Myelodysplastic Syndromes

Intervention

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
• Standard Leukemia care
Standard care per the hospital guideline

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of chemotherapy administration	compare rate of chemotherapy administration within 30 days of death between the two study arms	up to 30 days prior to death
Other	Rates of death in the hospital	compare rates of death in the hospital between the two study arms	up to 2 years
Other	caregiver-reported discussion of end-of-life care preferences as measured by the perception of treatment and prognosis questionnaire	compare caregiver-reported discussion of end-of-life care preferences between the study arms at one month	one month
Other	Compare quality of end-of-life care between the two study arms	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	up to 2 years
Primary	Time from documentation of end-of-life care preferences to death	comparison of time from documentation of end-of-life care preferences to death in the electronic health records	up to 2 years
Secondary	Rates of documentation of end-of-life care preferences at least one week prior to death.	Comparison of the rate of documentation of end-of-life care preferences at least one week prior to death in the electronic health record	up to 2 years
Secondary	Patient-report of discussing end-of-life care preferences based on an item from the perception of treatment and prognosis questionnaire	comparison of patient-report of discussion end-of-life care preferences between the study arms	up to 2 years
Secondary	Compare Rate of hospitalization between the study arms	Compare rates of hospitalizations within 30 days of death between the study arms	up to 30 days
Secondary	Rate of hospice utilization and length-of-stay in hospice	Compare rates of hospice utilization and length-of-stay in hospice at the end of life between the study arms	up to 2 years
Secondary	compare quality of life	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)	up to six months
Secondary	compare symptom burden	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.	up to six months
Secondary	compare mood	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	up to six months