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Background The family and friends (caregivers) of patients with advanced cancer often experience tremendous distress. Although early integrated palliative care (PC) has been shown to improve patient-reported quality of life (QOL) and mood, its effects on caregivers' outcomes is currently unknown. Materials and methods We conducted a randomized trial of early PC integrated with oncology care versus oncology care alone for patients who were newly diagnosed with incurable lung and noncolorectal gastrointestinal cancers and their caregivers. The early PC intervention focused on addressing the needs of both patients and their caregivers. Eligible caregivers were family or friends who would likely accompany patients to clinic visits. The intervention entailed at least monthly patient visits with PC from the time of diagnosis. Caregivers were encouraged, but not required, to attend the palliative care visits. We used the Hospital Anxiety and Depression Scale (HADS) and Medical Health Outcomes Survey Short-Form to assess caregiver mood and QOL. Results Two hundred seventy-five caregivers (intervention n = 137; control n = 138) of the 350 patients participated. The intervention led to improvement in caregivers' total distress (HADS-total adjusted mean difference = -1.45, 95% confidence interval [CI] -2.76 to -0.15, p = .029), depression subscale (HADS-depression adjusted mean difference = -0.71, 95% CI -1.38 to -0.05, p = .036), but not anxiety subscale or QOL at week 12. There were no differences in caregivers' outcomes at week 24. A terminal decline analysis showed significant intervention effects on caregivers' total distress (HADS-total), with effects on both the anxiety and depression subscales at 3 and 6 months before patient death. Conclusion Early involvement of PC for patients with newly diagnosed lung and gastrointestinal cancers leads to improvement in caregivers' psychological symptoms. This work demonstrates that the benefits of early, integrated PC models in oncology care extend beyond patient outcomes and positively impact the experience of caregivers. Implications for practice Early involvement of palliative care for patients with newly diagnosed lung and gastrointestinal cancers leads to improvement in caregivers' psychological symptoms. The findings of this trial demonstrate that the benefits of the early, integrated palliative care model in oncology care extend beyond patient outcomes and positively impact the experience of caregivers. These findings contribute novel data to the growing evidence base supporting the benefits of integrating palliative care earlier in the course of disease for patients with advanced cancer and their caregivers.

While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities.To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial.This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

Background Despite the well-established risks of persistent smoking, 10–30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.

BACKGROUND Patients with incurable cancer face many physical and emotional stressors, yet little is known about their coping strategies or the relationship between their coping strategies, quality of life (QOL), and mood. METHODS As part of a randomized trial of palliative care, this study assessed baseline QOL (Functional Assessment of Cancer Therapy–General), mood (Hospital Anxiety and Depression Scale), and coping (Brief COPE) in patients within 8 weeks of a diagnosis of incurable lung or gastrointestinal cancer and before randomization. To examine associations between coping strategies, QOL, and mood, we used linear regression, adjusting for patients' age, sex, marital status, and cancer type. RESULTS There were 350 participants (mean age, 64.9 years), and the majority were male (54.0%), were married (70.0%), and had lung cancer (54.6%). Most reported high utilization of emotional support coping (77.0%), whereas fewer reported high utilization of acceptance (44.8%), self-blame (37.9%), and denial (28.2%). Emotional support (QOL: β = 2.65, P < .01; depression: β = –0.56, P = .02) and acceptance (QOL: β = 1.55, P < .01; depression: β = –0.37, P = .01; anxiety: β = –0.34, P = .02) correlated with better QOL and mood. Denial (QOL: β = –1.97, P < .01; depression: β = 0.36, P = .01; anxiety: β = 0.61, P < .01) and self-blame (QOL: β = –2.31, P < .01; depression: β = 0.58, P < .01; anxiety: β = 0.66, P < .01) correlated with worse QOL and mood. CONCLUSIONS Patients with newly diagnosed, incurable cancer use a variety of coping strategies. The use of emotional support and acceptance coping strategies correlated with better QOL and mood, whereas the use of denial and self-blame negatively correlated with these outcomes. Interventions to improve patients' QOL and mood should seek to cultivate the use of adaptive coping strategies. Cancer 2016;122:2110–6. © 2016 American Cancer Society.

Objectives Lung cancer is the leading cause of cancer death, yet lung screening remains underutilized. Lung cancer screening uncertainty (LCSU), including referral clarity and the perceived accuracy of screening, may hinder utilization and represent an unmet psychosocial need. This study sought to identify correlates of LCSU among lung screening patients. Methods Current and former smokers (N = 169) completed questionnaires assessing LCSU, sociodemographic variables, objective and subjective numeracy, stress, and anxiety, as part of a cross-sectional study of lung screening patients at an academic hospital. Results Patients (52% current smok- ers) reported high clarity about the reason for their lung screening referral. Less clarity was as- sociated with lower education, not receiving Medicare, and greater stress and anxiety. Patients perceived lung screening to be moderately accurate, and levels were inversely related to objective numeracy. Subjective numeracy was higher among former versus current smokers (OR = 2.5), yet was unrelated to LCSU variables. Conclusions Several sociodemographic, numeracy, and emotional factors were associated with greater LCSU. With multiple policy and clinical guidelines purporting the uptake of annual lung screening, it is important to identify patients with LCSU and tailor shared decision-making to clarify their uncertainties.

Objective Patients with stage IV non-small cell lung cancer (NSCLC) have high risk for depressive symptoms and major depressive disorder (MDD); however, those with epidermal growth factor receptor ( EGFR ) mutations may have decreased risk. The biological underpinning of this relationship is unknown. We examined differences in depression severity and MDD in patients with newly diagnosed stage IV NSCLC based on EGFR mutation status, and examined proinflammatory cytokines and growth factors known to play a role in cancer progression and depression. Methods Fifty-five patients with newly diagnosed stage IV NSCLC completed self-report and clinician-administered depression assessments prior to receiving results of tumor genotyping. We measured serum levels of circulating biological markers of inflammation: IL-1β, IL-6, TGF-α, and TNF-α. We examined differences in depression severity, MDD, and inflammatory biomarkers in patients with and without EGFR mutations. Results Patients with EGFR mutations (n = 10) had lower depression severity ( t [43] = 2.38, p = 0.03) than those without EGFR mutations (n = 38) and fewer patients with EGFR mutations had concurrent MDD (2.08%) relative to those without mutations (27.08%). Patients with MDD had higher levels of TNF-α than those without MDD ( t [40] = 2.95, p = 0.005). Those with EGFR mutations exhibited higher levels of TNF-α relative to those without EGFR mutations ( t [35] = 2.17, p = 0.04). Conclusions Patients with stage IV NSCLC harboring an EGFR mutation exhibited elevated proinflammatory marker TNF-α, yet had lower depression severity than patients without EGFR mutations. More work is warranted to examine the interaction between tumor genotyping and inflammatory cytokines in the context of depression.

Purpose We evaluated the impact of early integrated palliative care (PC) in patients with newly diagnosed lung and GI cancer. Patients and Methods We randomly assigned patients with newly diagnosed incurable lung or noncolorectal GI cancer to receive either early integrated PC and oncology care (n = 175) or usual care (n = 175) between May 2011 and July 2015. Patients who were assigned to the intervention met with a PC clinician at least once per month until death, whereas those who received usual care consulted a PC clinician upon request. The primary end point was change in quality of life (QOL) from baseline to week 12, per scoring by the Functional Assessment of Cancer Therapy-General scale. Secondary end points included change in QOL from baseline to week 24, change in depression per the Patient Health Questionnaire-9, and differences in end-of-life communication. Results Intervention patients ( v usual care) reported greater improvement in QOL from baseline to week 24 (1.59 v −3.40; P = .010) but not week 12 (0.39 v −1.13; P = .339). Intervention patients also reported lower depression at week 24, controlling for baseline scores (adjusted mean difference, −1.17; 95% CI, −2.33 to −0.01; P = .048). Intervention effects varied by cancer type, such that intervention patients with lung cancer reported improvements in QOL and depression at 12 and 24 weeks, whereas usual care patients with lung cancer reported deterioration. Patients with GI cancers in both study groups reported improvements in QOL and mood by week 12. Intervention patients versus usual care patients were more likely to discuss their wishes with their oncologist if they were dying (30.2% v 14.5%; P = .004). Conclusion For patients with newly diagnosed incurable cancers, early integrated PC improved QOL and other salient outcomes, with differential effects by cancer type. Early integrated PC may be most effective if targeted to the specific needs of each patient population.

234 Background: Patients with newly diagnosed advanced cancers who receive early palliative care (PC) integrated with oncology care report improvement in their quality of life (QOL) and mood. While a telephone-based psycho-educational intervention for FC decrease depression, the impact of early, integrated outpatient PC models on FC outcomes remains unknown. Methods: We conducted a randomized trial of early PC integrated with oncology care versus oncology care alone for newly diagnosed patients with incurable lung and gastrointestinal cancers and their FC. Eligible FC were relatives or friends who would likely accompany the patient to clinic visits. FC were eligible to enroll up to 4 weeks after patient enrollment. The intervention entailed at least monthly patient visits with PC from the time of enrollment. FC were not required to attend these visits. We used the Medical Outcomes Study Health Survey Short Form-36 to examine QOL and the Hospital Anxiety and Depression Scale to examine mood at baseline, weeks 12 and 24. We used the two-sample t-test to examine changes in QOL and mood from baseline to week 12 and week 24. Results: We enrolled 350 patients and 275 (78.6%) of potentially eligible FC (control n = 138, intervention n = 137) between 5/2/2011 to 7/20/2015. FC outcomes missing data rate at 12 and 24 weeks were 16.8% and 33.8% respectively. At 12 weeks, FC of patients receiving early PC reported higher vitality (1.1 vs. -3.2, p = 0.05) and social functioning (-3.0 vs. -3.8, p = 0.02), and lower depression symptoms (-0.45 vs. 0.24, p = 0.03) compared to FC of patients assigned to usual care. At 24 weeks, FC of patients assigned to early PC had lower depression symptoms (-0.37 vs. 0.28, p = 0.05), but no differences in vitality or social functioning compared to those receiving usual care. No differences in other SF-36 subscales or anxiety were noted at 12 and 24 weeks. Conclusions: Early involvement of PC for patients with newly diagnosed lung and gastrointestinal cancers leads to improvements in FC depression and aspects of QOL. This work demonstrates that the benefits of early, integrated palliative care models in oncology care extend beyond patient outcomes and positively impact the experience of FC. Clinical trial information: NCT01401907.

10003Background: Early palliative care (PC) improves outcomes in patients with newly diagnosed metastatic non-small cell lung cancer (NSCLC) and in patients identified by clinicians as having poor prognosis, advanced cancer. We evaluated the impact of early, integrated palliative and oncology care in patients with newly diagnosed lung and gastrointestinal (GI) cancer. Methods: We randomly assigned patients with newly diagnosed incurable lung (NSCLC, small cell, mesothelioma) or GI (pancreas, hepatobiliary, gastric, esophageal) cancer to PC integrated with oncology care (at least monthly visits with PC) or usual oncology care. We used the Functional Assessment of Cancer Therapy-General (FACT-G) to assess quality of life (QOL) and the Patient Health Questionniare-9 (PHQ-9) and Hospital Anxiety and Depression Scale (HADS) for mood at baseline, weeks 12 and 24. We assessed patients’ perception of their likelihood of cure and their communication about their end of life (EOL) preferences. WΒe used linear regres...

10131Background: Patients with newly diagnosed advanced cancers who receive early palliative care (PC) integrated with oncology care report improvement in their quality of life (QOL) and mood. Whil...

269 Background: Hospital readmission rate is increasingly suggested as a quality care metric. Currently there are no standard criteria for an avoidable readmission in oncology. Although patients with cancer have been identified as being at increased risk of readmission, there has been little to examine the reasons for the oncology patient readmission. The aim was to examine the profiles of patients with an unplanned readmission within 30 days after discharge by an oncology provider and to measure the unplanned 30-day readmission rate. Methods: A retrospective review of oncology provider discharge encounters resulting in a 30-day unplanned readmission during the 2012 calendar year at a tertiary hospital with a comprehensive cancer center was conducted. Planned readmissions for chemotherapy, radiation therapy, hematopoietic stem cell transplantation, dialysis, and surgical procedures, as well as readmissions for rehabilitation, hospice, and psychiatry were excluded. Medical oncologists analyzed medical records for the primary reason of readmission and if the readmission was possibly preventable. Results: Of the 2,944 admissions, a final cohort of 441 unplanned readmissions from 321 unique patients for an unplanned 30-day readmission rate of 14.9% was observed. The average age at admission was 59 (SD 15.9). The cohort was mostly male (56.9%) and White/Caucasian (84.4%). Gastrointestinal (24.0%), lymphoma (18.6%), and leukemia (17.5%) were the most common cancer types. Of those with solid tumors types (n = 225), approximately 70% had metastatic disease. The median time to readmission was 10 days and 10.7% died within 30 days of readmission. Oncology reviewers most commonly assessed that readmission was primarily due to treatment-related effects (46.7%) and the progression of disease (42.2%). Approximately 20% of 30-day readmissions were determined to be possibly preventable, representing 3% of all admissions for the year. Conclusions: Oncology patients readmitted within 30-days frequently present with complicated, advanced disease. A review by medical oncologists suggests there is margin for intervention to reduce 30-day unplanned admissions.