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 Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT. Methods We conducted an unblinded, randomized trial of a psychosocial intervention (BMT‐CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT‐CARE or usual care. BMT‐CARE was tailored to the HCT trajectory and integrated treatment‐related education and self‐care with cognitive‐behavioral skills to promote coping. Caregivers assigned to BMT‐CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self‐efficacy (Cancer Self‐Efficacy Scale–Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT‐CARE on outcomes longitudinally. Results We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT‐CARE reported improved QOL (B = 6.11; 95% CI, 3.50‐8.71; P < .001), reduced caregiving burden (B = –6.02; 95% CI, –8.49 to –3.55; P < .001), lower anxiety (B = –2.18; 95% CI, –3.07 to –1.28; P < .001) and depression symptoms (B = –1.23; 95% CI, –1.92 to –0.54; P < .001), and improved self‐efficacy (B = 7.22; 95% CI, 2.40‐12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04‐6.94; P < .001) in comparison with the usual‐care group. Conclusions A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self‐efficacy while reducing the caregiving burden during the acute HCT period.

BACKGROUND: In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood. METHODS: From December 2017 to April 2019, 100 caregivers of HCT recipients were enrolled into a randomized clinical trial of BMT-CARE versus usual care. Caregivers completed self-report measures of QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment (before HCT) and 60 days after HCT. Causal mediation regression models were used to examine whether changes in coping and self-efficacy mediated intervention effects on QOL as well as depression and anxiety symptoms. RESULTS: Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05). Similarly, reductions in 60-day depression and anxiety symptoms were partially mediated by improved coping and self-efficacy (indirect effect for depression, −1.19; SE, 0.42; 95% CI, −2.23 to −0.53; indirect effect for anxiety, −1.46; SE, 0.55; 95% CI, −2.52 to −0.43). Combined improvements in coping and selfefficacy accounted for 67%, 80%, and 39% of the total intervention effects on QOL and depression and anxiety symptoms, respectively. CONCLUSIONS: Coping and self-efficacy are essential components of a brief psychosocial intervention that improves QOL and mood for caregivers of HCT recipients during the acute recovery period.