Collaborative care model for patients with acute leukemia and myelodysplastic syndromes
Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy
NA · Massachusetts General Hospital · NCT03310918
This study is testing if adding palliative care to regular treatment can help improve the quality of life and end-of-life experience for patients with acute leukemia and myelodysplastic syndromes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03310918 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a collaborative palliative care and oncology team on the end-of-life outcomes and quality of life for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) receiving non-intensive therapy. It aims to address the physical and emotional symptoms experienced by these patients, who often face a rapid decline in health and limited prognosis. The research compares standard oncology care with the involvement of palliative care clinicians to enhance symptom management and improve communication about prognosis and care preferences. The goal is to determine if early palliative care can lead to better overall patient care.
Who should consider this trial
Good fit: Ideal candidates are patients with AML receiving non-intensive therapy, including those newly diagnosed, relapsed, or primary refractory.
Not a fit: Patients receiving intensive chemotherapy or supportive care alone may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and end-of-life care for patients with AML and MDS.
How similar studies have performed: Other studies have shown that early palliative care can improve outcomes for patients with serious illnesses, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Areej El-Jawahri, MD — Massachusetts General Hospital
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@partners.org
- Phone: 617-726-5765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, AML, MDS, Palliative care