Acute myelogenous leukemia (AML) is a life-threatening blood cancer that affects approximately 20,000 individuals in the United States each year. Patients who develop AML have a rapid onset of symptoms such as fatigue and shortness of breath and are so severely ill that they are urgently hospitalized to initiate therapy. Most patients are treated with “intensive chemotherapy,” which is a combination of drugs that necessitates a four- to six-week hospitalization due to complications such as bleeding and infection. Despite this intensive treatment, most patients with AML are hospitalized multiple times for more treatments and to manage complications and die within one year. AML is an incredibly challenging diagnosis for both patients and their family and friends (“caregivers”) due to the difficult symptoms patients experience, the need for frequent lengthy hospitalizations, the uncertainty about the future, and the high likelihood of death. Studies show that despite the gravity of AML, the majority of patients do not receive adequate attention for their physical symptoms, patients and their caregivers receive insufficient support to address psychological distress, and patients receive intensive and costly care at the end of their life that is not consistent with their goals.
Involvement of specialty-trained palliative care (PC) is an efficacious strategy to address the physical, psychological, and end-of-life (EOL) care needs of patents with serious cancers. While this approach has been predominantly studied in patients with solid tumors, the team recently found that having specialty PC clinicians care for patients with AML improves patients’ quality of life (QOL), mood, and care at the EOL. Unfortunately, the majority of healthcare systems do not have the resources, staffing, and infrastructure to deliver specialty PC to all patients with serious cancers. Additionally, many oncology clinicians, especially those who care for patients with leukemia, are reluctant to involve PC, due to their sense of ownership for their patients. In response to this sense of responsibility by oncology clinicians and insufficient specialty PC resources and clinicians, there is growing interest in “primary PC” in which oncology clinicians are trained to address patients’ PC needs. At this time, it is unknown whether primary PC is an effective alternative strategy to specialty PC. Therefore, the goal of this study is to compare these PC models for patients with AML to determine if primary PC is an effective alternative to specialty PC for improving patients’ and their caregivers’ QOL and mood, and patient’s EOL care.
The study will be conducted at 20 Palliative Care Research Cooperative sites that are randomly assigned to deliver one of these two PC models. The team will train the appropriate clinicians at each site to deliver the PC model that they are assigned to. Hospitalized adult patients with high-risk AML receiving intensive chemotherapy at one of the 20 study sites and their caregivers will be eligible for study participation. The team chose study sites to ensure that the study population was geographically, racially, and ethnically diverse. Patients who receive their leukemia care at the 10 sites assigned to specialty PC will be seen twice weekly by the PC clinician each time they are admitted to the hospital. Patients at the 10 primary PC sites will be cared for by oncology clinicians who have undergone primary PC training. The primary study outcome is patients’ QOL at 12 weeks, but the team will collect data from participants throughout the first 24 weeks of the study and on EOL care for patients who die within one year. The team is also collecting data on the facilitators and barriers to implementing these care models to inform future dissemination of PC services.
This study will answer a critical question of how to best address the PC needs of patients with cancer and their caregivers and provide essential data on how healthcare systems can ensure optimal PC services are available for their patients. The team has a robust stakeholder plan with patients and caregivers, PC and oncology clinicians and investigators, healthcare system leaders and policy makers, and implementation and dissemination experts. The team also formed a study advisory committee with representatives from each of these groups to collaborate closely with the research team and provide guidance on implementing the study protocol, collecting outcomes, addressing challenges, and disseminating study results.