Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic.

Background: Adults with advanced lung cancer experience reduced health-related quality of life (HRQOL) and psychological symptoms at diagnosis. Objective: This study aimed to evaluate whether the COVID-19 pandemic worsened HRQOL among patients recently diagnosed with cancer. Design: We analyzed baseline data from two randomized controlled trials of early palliative care to compare HRQOL and depression symptoms among those enrolled during the pandemic (January 2020 to January 2021) versus prepandemic (March 2018 to January 2019). Setting/Subjects: This cohort included patients recently diagnosed with advanced lung cancer in two multisite studies. Measurements: We used analysis of covariance to calculate adjusted mean differences between groups with the timeframe as an independent variable and HRQOL (using the Functional Assessment of Cancer Therapy-General) and depression symptoms (using the Patient Health Questionnaire-9) as dependent variables, adjusting for age, gender, relationship status, performance status, symptoms, and time since diagnosis. We tested for an interaction between the COVID-19 timeframe and relationship status. Results: Neither HRQOL (adjusted mean difference -1.78; p = 0.137) nor depression symptoms (0.06; p = 0.889) differed between patients enrolled pre-COVID-19 (n = 665) relative to those enrolled during COVID-19 (n = 191) in adjusted analyses. Relationship status moderated the effect of the COVID-19 timeframe on HRQOL; unmarried patients experienced worse HRQOL during COVID-19 (adjusted mean difference: -5.25; p = 0.011). Conclusions: The COVID-19 pandemic did not further reduce HRQOL or increase depression symptoms among patients recently diagnosed with lung cancer, but did worsen HRQOL for unmarried patients in moderation analysis. Psychosocial evaluation and supportive care are important for all patients, particularly those with limited social support. Clinical trial registration numbers: NCT03337399 and NCT03375489.

Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.

INTRODUCTION: Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs. METHODS AND ANALYSIS: We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients. ETHICS AND DISSEMINATION: The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations. TRIAL REGISTRATION NUMBER: NCT03337399.

Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer: A Randomized Clinical Trial.

IMPORTANCE: Symptom monitoring interventions are increasingly becoming the standard of care in oncology, but studies assessing these interventions in the hospital setting are lacking. OBJECTIVE: To evaluate the effect of a symptom monitoring intervention on symptom burden and health care use among hospitalized patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS: This nonblinded randomized clinical trial conducted from February 12, 2018, to October 30, 2019, assessed 321 hospitalized adult patients with advanced cancer and admitted to the inpatient oncology services of an academic hospital. Data obtained through November 13, 2020, were included in analyses, and all analyses assessed the intent-to-treat population. INTERVENTIONS: Patients in both the intervention and usual care groups reported their symptoms using the Edmonton Symptom Assessment System (ESAS) and the 4-item Patient Health Questionnaire-4 (PHQ-4) daily via tablet computers. Patients assigned to the intervention had their symptom reports displayed during daily oncology rounds, with alerts for moderate, severe, or worsening symptoms. Patients assigned to usual care did not have their symptom reports displayed to their clinical teams. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of days with improved symptoms, and the secondary outcomes were hospital length of stay and readmission rates. Linear regression was used to evaluate differences in hospital length of stay. Competing-risk regression (with death treated as a competing event) was used to compare differences in time to first unplanned readmission within 30 days. RESULTS: From February 12, 2018, to October 30, 2019, 390 patients (76.2% enrollment rate) were randomized. Study analyses to assess change in symptom burden included 321 of 390 patients (82.3%) who had 2 or more days of symptom reports completed (usual care, 161 of 193; intervention, 160 of 197). Participants had a mean (SD) age of 63.6 (12.8) years and were mostly male (180; 56.1%), self-reported as White (291; 90.7%), and married (230; 71.7%). The most common cancer type was gastrointestinal (118 patients; 36.8%), followed by lung (60 patients; 18.7%), genitourinary (39 patients; 12.1%), and breast (29 patients; 9.0%). No significant differences were detected between the intervention and usual care for the proportion of days with improved ESAS-physical (unstandardized coefficient [B] = -0.02; 95% CI, -0.10 to 0.05; P = .56), ESAS-total (B = -0.05; 95% CI, -0.12 to 0.02; P = .17), PHQ-4-depression (B = -0.02; 95% CI, -0.08 to 0.04; P = .55), and PHQ-4-anxiety (B = -0.04; 95% CI, -0.10 to 0.03; P = .29) symptoms. Intervention patients also did not differ significantly from patients receiving usual care for the secondary end points of hospital length of stay (7.59 vs 7.47 days; B = 0.13; 95% CI, -1.04 to 1.29; P = .83) and 30-day readmission rates (26.5% vs 33.8%; hazard ratio, 0.73; 95% CI, 0.48-1.09; P = .12). CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that for hospitalized patients with advanced cancer, the assessed symptom monitoring intervention did not have a significant effect on patients' symptom burden or health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03396510.

Development of a Prognostic Awareness Impact Scale for Patients with Advanced Cancer.

Background: No reliable instruments exist to measure prognostic awareness and its psychological and behavioral impacts for patients with advanced cancer. Methods: We developed the Prognostic Awareness Impact Scale (PAIS) using a qualitative approach. During phase 1, we convened a working group with a transdisciplinary team of clinicians from oncology (n = 2), psychology (n = 2), psychiatry (n = 1), palliative care (n = 3), and survey development (n = 1) to identify key domains of PAIS. Using a consensus-driven process, the team generated an item bank for each domain. During phase 2, we conducted cognitive interviews with 39 patients with advanced cancer to assess the understandability of the PAIS. Results: The working group developed a conceptual framework for PAIS, identifying three domains: (1) cognitive understanding of prognosis (capacity to understand intellectually one's prognosis), (2) emotional coping (capacity to process prognostic uncertainty and terminal prognosis), and (3) adaptive response (capacity to use prognostic awareness to inform life decisions). Cognitive interviews revealed that patients had an accurate understanding of most PAIS items. Patients reported difficulty with binary response options for questions pertaining to emotional coping. They expressed difficulty answering numerous questions regarding their cognitive understanding of their prognosis. We revised the PAIS by (1) replacing binary response options with ordinal agreement scales; and (2) reducing the number of items focused on cognitive understanding of prognosis. Conclusion: We developed a conceptual framework to capture prognostic awareness and its psychological and behavioral impacts for patients with advanced cancer using the PAIS. Future work should focus on validating the PAIS by testing its psychometric properties.

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.

Psychological Distress in Bereaved Caregivers of Patients With Advanced Cancer.

CONTEXT: Individuals caring for patients with advanced cancer (caregivers) experience psychological distress during the patient's illness course. However, data on the prevalence of bereaved caregivers' psychological distress and its relationship with the quality of patient's end of life (EOL) care are limited. OBJECTIVES: To describe rates of depression and anxiety symptoms in bereaved caregivers of patients with advanced cancer and to understand the relationship between these outcomes and patient distress at the EOL. METHODS: We conducted a secondary analysis of 168 caregivers enrolled in a supportive care trial for patients with incurable lung and gastrointestinal cancers and their caregivers. We used the Hospital Anxiety and Depression Scale to assess caregivers' depression and anxiety symptoms at three months after the patient's death. Caregivers also rated the patient's physical and psychological distress in the last week of life on a 10-point scale three months after the patient death. We used linear regression adjusting for caregiver age, sex, randomization, and cancer type to explore the relationship between bereaved caregivers' depression and anxiety symptoms and their ratings of physical and psychological distress in patients at the EOL. RESULTS: Of the 168 bereaved caregivers, 30.4% (n = 51) and 43.4% (n = 73) reported clinically significant depression and anxiety symptoms, respectively. Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers. Only caregiver rating of worse psychological distress experienced by the patient at the EOL (B = 0.42; P < 0.001) was associated with worse bereaved caregivers' anxiety symptoms. CONCLUSION: Many bereaved caregivers of patients with advanced cancer experience symptoms of depression and anxiety, which are associated with their perceptions of distress in their loved ones at the EOL.