Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial

Abstract

Importance: Patients 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 participants: We 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 measures: Patients 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.

Results: Of 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 relevance: In 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02975869.

Conflict of interest statement

Conflict of Interest Disclosures: Dr El-Jawahri reports being a scholar in clinical research for the Leukemia & Lymphoma Society. Dr Bhatnagar reports receiving honoraria from serving on advisory boards at Cell Therapeutics, Kite Pharma, Pfizer, Astellas, and Novartis, as well as research support from Karyopharm Therapeutics and Cell Therapeutics. Dr Brunner reports serving on the advisory boards of Celgene/Bristol Myers Squibb, Novartis, Forty Seven, and Jazz Pharmaceuticals, as well as being a consultant for Takeda. Dr Fathi reports receiving personal fees from Boston Biomedical, Jazz Pharmaceuticals, PTC Therapeutics, Amphivena Therapeutics, Daiichi Sankyo, Astellas Pharma, Trovagene, Forty Seven, Pfizer, NewLink Genetics, AbbVie, Seattle Genetics, Amgen, Kura Oncology, and Trillium Therapeutics, as well as grants and personal fees from Agios Pharmaceuticals, Takeda, and Celgene/Bristol Myers Squibb. Dr Greer reports receiving consultant reimbursement from Concerto HealthAI, research funding from Gaido Health/BCG Digital Ventures, royalties from Springer’s Humana Press, and research grants from Pfizer and AstraZeneca through the National Comprehensive Cancer Network. Dr Hobbs reports receiving personal fees from Incyte, Novartis, Celgene, Agios Pharmaceuticals, and Jazz Pharmaceuticals. Dr LeBlanc reports receiving personal fees from AbbVie, Agios Pharmaceuticals, Amgen, Daiichi Sankyo, Heron Therapeutics, Otsuka, and Pfizer; grants from Seattle Genetics, the American Cancer Society, and Cambia Health Foundation; and grants and personal fees from AstraZeneca, Celgene/Bristol Myers Squibb, and Jazz Pharmaceuticals; he is also a Cambia Sojourns Scholar. Dr Luger reports receiving personal fees from Bristol Myers Squibb, Pfizer, Acceleron, Daiichi Sankyo, and Agios; grants from Onconova Therapeutics, Kura Oncology, Hoffmann-La Roche, ARIAD Pharmaceuticals, and BioSight; and grants and personal fees from Celegene. Dr Temel reports receiving grants from Pfizer. No other disclosures were reported.

Figures

Figure 1.. Consort Diagram

Figure 2.. Effect of Integrated Palliative and Oncology Care on Patient-Reported Quality of Life and Psychological Distress by Scale

When compared with patients assigned to usual care, patients assigned to integrated palliative and oncology care reported better quality of life (β, 2.35; 95% CI, 0.02-4.68; P = .048) (A), lower anxiety (β, −0.38; 95% CI, −0.75 to −0.01; P = .04) (B), lower depression (β, −0.42; 95% CI, −0.82 to −0.02; P = .04) (C), and fewer posttraumatic stress disorder (PTSD) symptoms (β, −1.43; 95% CI, −2.34 to −0.54; P = .002) (D).