Weathering the storm when the end of the road is near: A qualitative analysis of supportive care needs during CAR T-cell therapy in pediatrics.

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy provides promising outcomes in relapsed/refractory B acute lymphoblastic leukemia (ALL), yet still carries high toxicity rates and relatively poor long-term survival. Efficacy has yet to be demonstrated in other diagnoses while toxicity and risk profiles remain formidable. To date, treatment-related symptom burden is gleaned from clinical trial toxicity reports; the patient perspective remains understudied. METHODS: English- or Spanish-speaking patients (ages 8-25 years) undergoing CAR T-cell therapy for any malignancy and their primary caregivers were recruited from Seattle Children's Hospital (SCH), St. Jude Children's Research Hospital (SJCRH), and the Pediatric Oncology Branch of the National Cancer Institute (NCI). Both patient and caregiver completed semi-structured dyadic interviews 3 months post treatment. We used directed content analysis for codebook development and thematic network analysis for inductive qualitative analysis. RESULTS: Twenty families completed interviews (13 patients, 15 parents). Patients were a median age 16.5 years, predominantly female (65%), White (75%), and diagnosed with ALL (75%). Global themes included "A clear decision," "Coping with symptoms," and "Unforeseen psychosocial challenges." When families were asked to describe the "most challenging part of treatment," most described "the unknown." Most reported "the symptoms really weren't that bad," even among patients hospitalized for severe toxicity events. Fatigue, pain, and nausea were the most prevalent symptoms. Importantly, only one family would have chosen a different therapy, if given another opportunity. CONCLUSIONS: Although physical symptoms were largely tolerable, recognizing supportive care opportunities remains imperative, particularly psychosocial concerns.

Pilot Randomized Controlled Trial of an Educational Video for CAR T-Cell Therapy Recipients.

BACKGROUND: CAR T-cell therapy has transformed the treatment of hematologic malignancies, but it is complex and challenging to convey to patients. Educational video interventions are efficacious for improving patient knowledge about cancer therapeutics and informing their care preferences, yet no educational videos have been evaluated in CAR T-cell therapy. METHODS: We conducted a randomized controlled trial comparing an educational video versus usual care in adults (age ≥18 years) with hematologic malignancies receiving CAR T-cell therapy at Massachusetts General Hospital. Intervention participants watched a 13-minute video depicting how CAR T-cell therapy works, logistics, toxicities, prognosis, recovery, and approaches for dealing with prognostic uncertainty. The primary outcome was feasibility (≥60% enrollment rate). Secondary outcomes included acceptability (≥80% reporting comfort with the video), patients' knowledge about CAR T-cell therapy (10-item test), and self-efficacy (Communication and Attitudinal Self-Efficacy Scale-Cancer), decision satisfaction (Decision Conflict Scale), psychological distress (Hospital Anxiety and Depression Scale), and preference for CAR T-cell therapy. RESULTS: We enrolled 79% (80/101) of eligible patients. Of that group, 91% (30/33) reported being very or somewhat comfortable watching the video, and 94% (31/33) would definitely or probably recommend the video. At 1 month, participants in the video arm reported higher self-efficacy (mean difference [MD], 9.2 [95% CI, -4.0 to 22.3]; Cohen's d, 0.32), decision satisfaction (MD, 2.5 [95% CI, 0.7-4.2]; Cohen's d, 0.67), and lower anxiety (MD, -0.8 [95% CI, -2.5 to 0.7]; Cohen's d, 0.26) compared with participants in the usual care arm. At 1 week, both arms reported high preferences for CAR T-cell therapy (video arm, 94% [33/35]; usual care, 84% [27/32]). CONCLUSIONS: We found that an educational video for patients receiving CAR T-cell therapy was feasible and acceptable. The educational video demonstrated promising preliminary effects on patient self-efficacy and decision satisfaction and warrants further study.

Longitudinal patient-reported outcomes in patients receiving chimeric antigen receptor T-cell therapy.

Chimeric antigen receptor T-cell therapy (CAR-T) has transformed the treatment for relapsed/refractory hematologic malignancies; however, data on patient-reported outcomes in CAR-T are limited. We conducted a longitudinal study of adults with hematologic malignancies receiving CAR-T. We assessed quality of life (QOL; functional assessment of cancer therapy-general), psychological distress (hospital anxiety and depression scale, patient health questionnaire-9, posttraumatic stress disorder [PTSD] checklist), and physical symptoms (Edmonton symptom assessment scale-revised) at baseline, 1 week, 1, 3, and 6 months after CAR-T. We used linear mixed models to identify factors associated with QOL trajectory. We enrolled 103 of 142 eligible patients (3 did not receive CAR-T). QOL (B = 1.96; P < .001) and depression (B = -0.32; P = .001) worsened by 1 week and improved by 6 months after CAR-T. At 6 months, 18%, 22%, and 22% reported clinically significant depression, anxiety, and PTSD symptoms, respectively. At 1 week, 52% reported severe physical symptoms, declining to 28% at 6 months after CAR-T. In unadjusted linear mixed models, worse Eastern Cooperative Oncology Group performance status (B = 1.24; P = .042), receipt of tocilizumab (B = 1.54; P = .042), and receipt of corticosteroids for cytokine release syndrome and/or neurotoxicity (B = 2.05; P = .006) were associated with higher QOL trajectory. After CAR-T, QOL declined, and depression increased early, followed by improvements in QOL, psychological distress, and physical symptoms by 6 months after infusion. A significant minority of patients reported substantial psychological distress and physical symptoms longitudinally.

Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial.

BACKGROUND: Patients with acute myeloid leukemia (AML) experience a substantial decline in quality of life (QoL) and mood during their hospitalization for intensive chemotherapy, yet few interventions have been developed to enhance patient-reported outcomes during treatment. METHODS: We conducted a pilot randomized trial (ClinicalTrials.gov identifier NCT03372291) of DREAMLAND, a psychological mobile application for patients with a new diagnosis of AML who are receiving intensive chemotherapy. Patients were randomly assigned to DREAMLAND or usual care. DREAMLAND included four required modules focused on: (1) supportive psychotherapy to help patients deal with the initial shock of diagnosis, (2) psychoeducation to manage illness expectations, (3) psychosocial skill-building to promote effective coping, and (4) self-care. The primary end point was feasibility, which was defined as ≥60% of eligible patients enrolling and 60% of those enrolled completing ≥60% of the required modules. We assessed patient QoL (the Functional Assessment of Cancer Therapy-Leukemia), psychological distress (the Hospital Anxiety and Depression Scale and the Patient Health Questionnaire-9), symptom burden (the Edmonton Symptom Assessment Scale), and self-efficacy (the Cancer Self-Efficacy Scale) at baseline and at day 20 after postchemotherapy. RESULTS: We enrolled 60 of 90 eligible patients (66.7%), and 62.1% completed ≥75% of the intervention modules. At day 20 after chemotherapy, patients who were randomized to DREAMLAND reported improved QoL scores (132.06 vs. 110.72; p =.001), lower anxiety symptoms (3.54 vs. 5.64; p = .010) and depression symptoms (Hospital Anxiety and Depression Scale: 4.76 vs. 6.29; p = .121; Patient Health Questionnaire-9: 4.62 vs. 8.35; p < .001), and improved symptom burden (24.89 vs. 40.60; p = .007) and self-efficacy (151.84 vs. 135.43; p = .004) compared with the usual care group. CONCLUSIONS: A psychological mobile application for patients with newly diagnosed AML is feasible to integrate during hospitalization for intensive chemotherapy and may improve QoL, mood, symptom burden, and self-efficacy.

Decreasing Burnout and Improving Work Environment: The Impact of Firgun on a Pediatric Hematopoietic Cell Transplant Team.

PURPOSE: Oncology teams are challenged by BO, which may be alleviated by meaningful recognition. In this study, firgun-altruistic acknowledgment-was implemented on a pediatric hematopoietic cell transplant unit to evaluate its impact on staff and work environment. METHODS: In this longitudinal, mixed-methods pilot study, interdisciplinary inpatient hematopoietic cell transplant providers received web-based firgun education. Electronic administration of validated surveys occurred at baseline and 8 weeks, including Perceived Stress Scale, Professional Quality of Life Scale, Maslach Burnout Inventory, Workplace Civility Index, Areas of Work Life Survey, and WHO-5. Weekly e-mails reminded participants to practice and log firgun. Wilcoxon signed test for paired data compared pre/post results. Interviews conducted at project completion were coded using MaxQDA software. RESULTS: Forty-two participants enrolled; 25 completed pre/post surveys; eight were interviewed. At study end, participants reported feeling less nervous and stressed (P = .008), and less difficulty coping (P = .01; Perceived Stress Scale), while noting increased acknowledgment of others' work (P = .04) and seeking constructive feedback (P = .04; Workplace Civility Index). Marked BO was not evident overall on the Maslach Burnout Inventory; however, emotional exhaustion subscale mean (SD) scores improved from pre (19.4 [8.6]) to post (16 [6.3; P = .02]) and individual items illustrated decreased fatigue (P = .008), frustration (P = .04), and feeling "at the end of my rope" (P = .001). Postintervention participants noted increased receipt of recognition (P = .02; Areas of Work Life Survey), decreased feeling "bogged down" (P = .02), decreased affective stress (P = .04), and negative pre-occupations (P = .04; Professional Quality of Life Scale). Qualitative analysis revealed themes of improved confidence at work and enhanced feelings of trust and teamwork. CONCLUSION: Firgun is a tool that can potentially reduce BO and stress in interdisciplinary providers, facilitate teamwork, and promote positive work environments in clinical oncology and beyond.

Factors Associated with Health Care Utilization at the End of Life for Patients with Acute Myeloid Leukemia.

Background: Patients (≥60 years) with acute myeloid leukemia (AML) often receive intense health care utilization at the end of life (EOL). However, factors associated with their health care use at the EOL are unknown. Methods: We conducted a secondary analysis of 168 deceased patients with AML within the United States. We assessed quality of life (QOL) (Functional-Assessment-Cancer-Therapy-Leukemia), and psychological distress (Hospital-Anxiety-and-Depression Scale [HADS]; Patient-Health-Questionnaire-9 [PHQ-9]) at diagnosis. We used multivariable logistic regression models to examine the association between patient-reported factors and the following outcomes: (1) hospitalizations in the last 7 days of life, (2) receipt of chemotherapy in the last 30 days of life, and (3) hospice utilization. Results: About 66.7% (110/165) were hospitalized in the last 7 days of life, 51.8% (71/137) received chemotherapy in the last 30 days of life, and 40.7% (70/168) utilized hospice. In multivariable models, higher education (odds ratio [OR] = 1.54, p = 0.006) and elevated baseline depression symptoms (PHQ-9: OR = 1.09, p = 0.028) were associated with higher odds of hospitalization in the last seven days of life, while higher baseline QOL (OR = 0.98, p = 0.009) was associated with lower odds of hospitalization at the EOL. Higher baseline depression symptoms were associated with receipt of chemotherapy at the EOL (HADS-Depression: OR = 1.10, p = 0.042). Higher education was associated with lower hospice utilization (OR = 0.356, p = 0.024). Conclusions: Patients with AML who are more educated, with higher baseline depression symptoms and lower QOL, were more likely to experience high health care utilization at the EOL. These populations may benefit from interventions to optimize the quality of their EOL care.

Posttraumatic stress disorder symptoms in patients with acute myeloid leukemia.

BACKGROUND: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy face a life-threatening illness, isolating hospitalization, and substantial physical and psychological symptoms. However, data are limited regarding risk factors of posttraumatic stress disorder (PTSD) symptoms in this population. METHODS: The authors conducted a secondary analysis of data from 160 patients with high-risk AML who were enrolled in a supportive care trial. The PTSD Checklist-Civilian Version was used to assess PTSD symptoms at 1 month after AML diagnosis. The Brief COPE and the Functional Assessment of Cancer Therapy-Leukemia were to assess coping and quality of life (QOL), respectively. In addition, multivariate regression models were constructed to assess the relation between PTSD symptoms and baseline sociodemographic factors, coping, and QOL. RESULTS: Twenty-eight percent of patients reported PTSD symptoms, describing high rates of intrusion, avoidance, and hypervigiliance. Baseline sociodemographic factors significantly associated with PTSD symptoms were age (B = -0.26; P = .002), race (B = -8.78; P = .004), and postgraduate education (B = -6.30; P = .029). Higher baseline QOL (B = -0.37; P ≤ .001) and less decline in QOL during hospitalization (B = -0.05; P = .224) were associated with fewer PTSD symptoms. Approach-oriented coping (B = -0.92; P = .001) was associated with fewer PTSD symptoms, whereas avoidant coping (B = 2.42; P ≤ .001) was associated with higher PTSD symptoms. CONCLUSIONS: A substantial proportion of patients with AML report clinically significant PTSD symptoms 1 month after initiating intensive chemotherapy. Patients' baseline QOL, coping strategies, and extent of QOL decline during hospitalization emerge as important risk factors for PTSD, underscoring the need for supportive oncology interventions to reduce the risk of PTSD in this population.

Clinical Outcomes of Patients Hospitalized with Coronavirus Disease 2019 (COVID-19) in Boston.

BACKGROUND: Outcomes of hospitalized patients with COVID-19 have been described in health systems overwhelmed with a surge of cases. However, studies examining outcomes of patients admitted to hospitals not in crisis are lacking. OBJECTIVE: To describe clinical characteristic and outcomes of all patients with COVID-19 who are admitted to hospitals not in crisis, and factors associated with mortality in this population. DESIGN: A retrospective analysis PARTICIPANTS: In total, 470 consecutive patients with COVID-19 requiring hospitalization in one health system in Boston from January 1, 2020 to April 15, 2020. MAIN MEASURES: We collected clinical outcomes during hospitalization including intensive care unit (ICU) admission, receipt of mechanical ventilation, and vasopressors. We utilized multivariable logistic regression models to examine factors associated with mortality. KEY RESULTS: A total of 470 patients (median age 66 [range 23-98], 54.0% male) were included. The most common comorbidities were diabetes (38.5%, 181/470) and obesity (41.3%, 194/470). On admission, 41.9% (197/470) of patients were febrile and 60.6% (285/470) required supplemental oxygen. During hospitalization, 37.9% (178/470) were admitted to the ICU, 33.6% (158/470) received mechanical ventilation, 29.4% (138/470) received vasopressors, 16.4% (77/470) reported limitations on their desire for life-sustaining therapies such as intubation and cardiopulmonary resuscitation, and 25.1% (118/470) died. Among those admitted to the ICU (N=178), the median number of days on the ventilator was 10 days (IQR 1-29), and 58.4% (104/178) were discharged alive. Older age (OR=1.04, P<0.001), male sex (OR=2.14, P=0.007), higher comorbidities (OR=1.20, P=0.001), higher lactate dehydrogenase on admission (2nd tertile: OR=4.07, P<0.001; 3rd tertile: OR=8.04, P<0.001), and the need for supplemental oxygen on admission (OR=2.17, P=0.014) were all associated with higher mortality. CONCLUSIONS: The majority of hospitalized patients with COVID-19 and those who received mechanical ventilation survived. These data highlight the need to examine public health and system factors that contribute to improved outcomes for this population.

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

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 (ß, 2.35; 95% CI, 0.02-4.68; P = .048), depression (ß, -0.42; 95% CI, -0.82 to -0.02; P = .04), anxiety (ß, -0.38; 95% CI, -0.75 to -0.01; P = .04), and PTSD symptoms (ß, -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.

Student perspectives on asthma management in schools: a mixed-methods study examining experiences, facilitators, and barriers to care.

Objective: Children spend nearly a third of their day at school, making it a critical point of intervention for those with asthma. This study aimed to illuminate minority students' experiences with asthma at school and perceptions of facilitators and barriers to care. Methods: A mixed-methods study was conducted with elementary students with asthma. Participants completed a 24-question survey, drawing exercise to depict experiences caring for their asthma at school, and focus group discussion. Drawings were analyzed for narrative and pictorial themes. Discussions were audio-recorded, transcribed, and independently coded for themes. Results: Fifteen children with asthma (8-11 years) participated from two Chicago schools with predominately African-American populations. Most students (79%) indicated they had control of asthma at school, while 85% identified asthma as a problem when exercising. Half (53%) received help with asthma care at school. Drawings depicted cooperative management with adults or peers and the central role of inhalers as part of everyday asthma care in school. Finally, focus groups produced six key themes within the domains of facilitators: 1) support of others, 2) self-efficacy; 3) perception of being normal; and barriers: 4) lack of support from others; 5) difficulty accessing inhaler; 6) perception of being different. Conclusions: This study suggests asthma care plays an important role in students' school experiences. Stigma around inhaler use, lack of concern by school staff, and limited access to medications remain as barriers to school-based asthma management. Although facilitators, such as support from teachers and peers, do exist, future interventions must address existing barriers.