IMPORTANCEPatients with acute myeloid leukemia (AML) receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). However, the role of specialty palliative care for improving the QOL and care for this population is currently unknown.OBJECTIVE To assess the effect of integrated palliative and oncology care (IPC) on patient-reported and EOL outcomes in patients with AML. DESIGN, SETTING, AND PARTICIPANTSWe conducted a multisite randomized clinical trial of IPC (n = 86) vs usual care (UC) (n = 74) for patients with AML undergoing intensive chemotherapy. Data were collected from January 2017 through July 2019 at 4 tertiary care academic hospitals in the United States.INTERVENTIONS Patients assigned to IPC were seen by palliative care clinicians at least twice per week during their initial and subsequent hospitalizations. MAIN OUTCOMES AND MEASURESPatients completed the 44-item Functional Assessment of Cancer Therapy-Leukemia scale (score range, 0-176) to assess QOL; the 14-item Hospital Anxiety and Depression Scale (HADS), with subscales assessing symptoms of anxiety and depression (score range, 0-21); and the PTSD Checklist-Civilian version to assess posttraumatic stress disorder (PTSD) symptoms (score range, 17-85) at baseline and weeks 2, 4, 12, and 24. The primary end point was QOL at week 2. We used analysis of covariance adjusting and mixed linear effect models to evaluate patient-reported outcomes. We used Fisher exact test to compare patient-reported discussion of EOL care preferences and receipt of chemotherapy in the last 30 days of life. RESULTSOf 235 eligible patients, 160 (68.1%) were enrolled; of the 160 participants, the median (range) age was 64.4 (19.7-80.1) years, and 64 (40.0%) were women. Compared with those receiving UC, IPC participants reported better QOL (adjusted mean score, 107.59 vs 116.45; P = .04), and lower depression (adjusted mean score, 7.20 vs 5.68; P = .02), anxiety (adjusted mean score, 5.94 vs 4.53; P = .02), and PTSD symptoms (adjusted mean score, 31.69 vs 27.79; P = .01) at week 2. Intervention effects were sustained to week 24 for QOL (β, 2.35; 95% CI, 0.02-4.68; P = .048), depression (β, −0.42; 95% CI, −0.82 to −0.02; P = .04), anxiety (β, −0.38; 95% CI, −0.75 to −0.01; P = .04), and PTSD symptoms (β, −1.43; 95% CI, −2.34 to −0.54; P = .002). Among patients who died, those receiving IPC were more likely than those receiving UC to report discussing EOL care preferences (21 of 28 [75.0%] vs 12 of 30 [40.0%]; P = .01) and less likely to receive chemotherapy near EOL (15 of 43 [34.9%] vs 27 of 41 [65.9%]; P = .01). CONCLUSIONS AND RELEVANCEIn this randomized clinical trial of patients with AML, IPC led to substantial improvements in QOL, psychological distress, and EOL care. Palliative care should be considered a new standard of care for patients with AML.

Background: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy face a life-threatening illness, experience a prolonged, isolating hospitalization, and endure substantial physical and psychological symptoms. Some patients with AML experience traumatic stress as a result of their diagnosis and illness course. As traumatic stress reactions can negatively impact patients' QOL, mood, and clinical outcomes, it is essential to understand the extent of this trauma, its clinical manifestations, and risk factors to inform targeted management strategies. Post-traumatic stress disorder (PTSD), characterized by experiencing a traumatic event, is a common stress related disorder in cancer populations. Despite the potential link between AML and PTSD, data are limited regarding risk and risk factors of PTSD symptoms in this population. Methods: We conducted a secondary analysis of 160 patients with high-risk AML hospitalized to receive intensive chemotherapy. We used the Post-Traumatic Stress Disorder Checklist-Civilian Version to assess PTSD symptoms at one month after diagnosis of AML. We used the Brief COPE, and Functional Assessment of Cancer Therapy-Leukemia at baseline and week-2 during hospitalization to assess coping and quality of life (QOL), respectively. We then used multivariate regression models to assess the relationship between PTSD symptoms at one month and patient baseline sociodemographic factors, coping, and QOL. Results: Twenty-eight percent of patients reported clinically significant PTSD symptoms, describing high rates of intrusion (92%), avoidance (100%), and hypervigilance (97%). Among those who did not have clinically significant PTSD symptoms, 27%, 26%, and 23% of patients reported clinically significant intrusion, avoidance, and hypervigilance symptoms, respectively. In adjusted analyses, higher baseline QOL (B= -.22, p= <.001) and less decline in QOL during hospitalization (B= -.17, p=.018) were associated with fewer PTSD symptoms. The use of approach-oriented coping (B= -.72; p= .018) was also associated with fewer PTSD symptoms, while the use of avoidant coping was not significantly associated with PTSD symptoms. Conclusion: A substantial proportion of patients with AML report clinically significant PTSD symptoms at one month after initiating intensive chemotherapy. These findings highlight the need to routinely screen, assess, and manage PTSD symptoms in all patients with AML. Patients' baseline QOL, coping strategies, and extent of QOL decline during hospitalization are important risk factors for PTSD symptoms, underscoring potential intervention targets in future studies to reduce the impact of PTSD in this population. Disclosures LeBlanc: Heron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Medtronic: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Welvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; American Cancer Society: Research Funding; BMS: Research Funding; Duke University: Research Funding; NINR/NIH: Research Funding; Jazz Pharmaceuticals: Research Funding; UpToDate: Patents & Royalties; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy, Honoraria, Research Funding, Speakers Bureau; CareVive: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS/Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Flatiron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Hobbs:Merck: Research Funding; Incyte: Research Funding; Celgene/BMS: Honoraria; Novartis: Honoraria; Jazz: Honoraria; Bayer: Research Funding; Constellation: Honoraria, Research Funding. Brunner:Novartis: Research Funding; AstraZeneca: Research Funding; Forty-Seven Inc: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Takeda: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Luger:Daiichi-Sankyo: Honoraria; Pfizer: Honoraria; Bristol-Myers Squibb: Honoraria; Acceleron: Honoraria; Agios: Honoraria; Loxo Oncology: Honoraria; Onconova: Research Funding; Kura: Research Funding; Hoffman La Roche: Research Funding; Ariad: Research Funding; Biosight: Research Funding. Bhatnagar:KITE: Membership on an entity's Board of Directors or advisory committees; KaryoPharm Therapuetics: Research Funding; Cell Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees.

BACKGROUND: It has been shown previously that integrated palliative care for patients with acute myeloid leukemia (AML) during intensive chemotherapy leads to improvements in quality of life (QOL) and mood. Coping has been shown to mediate palliative care interventions in advanced cancer; the mechanisms by which improvements occur among patients with AML remain unexplained. METHODS:The authors conducted a secondary analysis of data from a multisite randomized trial of integrated palliative and oncology care (IPC; n = 86) versus usual care (n = 74) for hospitalized patients with AML undergoing intensive chemotherapy. IPC patients met with palliative care at least twice weekly during their initial and subsequent hospitalizations. Patients completed the Functional Assessment of Cancer Therapy-Leukemia, the Hospital Anxiety and Depression Scale, and the Brief Coping Orientation to Problems Experienced Inventory to assess QOL, mood, and coping at the baseline and at weeks 2, 4, 12, and 24. Linear regression models were used to assess the effect of IPC on coping. Causal mediation regression models were used to examine whether changes in coping mediated intervention effects on patient-reported outcomes at week 2. RESULTS: One hundred sixty eligible patients (68.1%) were enrolled. Those randomized to IPC reported improvements in approach-oriented coping (P < .01) and reductions in avoidant coping (P < .05). These changes in coping mediated the intervention effects on QOL (95% CI, 2.14 to 13.63), depression (95% CI, -2.05 to -0.27), and anxiety symptoms (95% CI, -1.25 to -0.04). Changes in approach-oriented and avoidant coping accounted for 78% of the total palliative care intervention effect on QOL, for 66% of the effect on depression, and for 35% of the effect on anxiety symptoms. CONCLUSIONS: Palliative care integrated during intensive chemotherapy for patients with AML facilitates coping strategy use. Improvement in coping skills accounts for a substantial proportion of the effect from a palliative care intervention on patient-reported outcomes. Cancer 2021;127:4702-4710.