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Background Phase 1 trials are increasingly important in the molecularly driven era of oncology, but few studies have examined phase 1 participation disparities. The authors of this study investigated factors associated with phase 1 versus phase 2/3 trial enrollment. Methods They authors conducted a cross-sectional study using serial samples of patients age ≥18 years enrolling on cancer trials from October 2011 to November 2014 at an academic cancer center. They used univariable and multivariable logistic regression models to analyze sociodemographic and clinical associations with phase 1 versus phase 2/3 trial enrollment. Results Among 3103 patients enrolled in cancer trials, 2657 unique patients participated in phase 1/2/3 trials. For patients enrolled in phase 1 (n = 1401) versus phase 2/3 (n = 1256) trials, we found no significant differences by age, insurance status, marital status, and income. Overall, 1216 (93%) White, 72 (6%) Asian, and 21 (2%) Black patients enrolled on phase 1 trials, whereas 1068 (93%) White, 40 (3%) Asian, and 43 (4%) Black patients enrolled on phase 2/3 trials. Adjusting for age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year, compared with White patients, Black patients had lower phase 1 enrollment (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.25-0.82), as did Hispanic/Latino (OR, 0.25; 95% CI, 0.08-0.79) and male patients (OR, 0.77; 95% CI, 0.62-0.94). Asian patients had higher phase 1 enrollment (OR, 1.38; 95% CI, 0.88-2.16). Conclusions Disparities in phase 1 versus phase 2/3 cancer clinical trial enrollment underscore the urgent need for interventions addressing inequities in early-phase trial participation. Lay summary Phase 1 trials are of increasing importance in oncology. The authors of the study analyzed all patients enrolling on cancer clinical trials at a large academic cancer center from October 2011 to November 2014. Among the 2657 trial participants, when age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year were taken into account, Black, Hispanic/Latino, and male patients were less likely to enroll on phase 1 trials versus phase 2/3 trials. These findings suggest a need for targeted interventions to improve access to and education about phase 1 trials for Black and Hispanic/Latino patients.

Background Medical financial burden includes material, behavioral, and psychological hardship and has been underinvestigated among adult survivors of childhood cancer. Methods A survey from 698 survivors and 210 siblings from the Childhood Cancer Survivor Study was analyzed. The intensity of financial hardship was estimated across 3 domains: 1) material, including conditions that arise from medical expenses; 2) behavioral, including coping behaviors to manage medical expenses; and 3) psychological hardship resulting from worries about medical expenses and insurance, as measured by the number of instances of each type of financial hardship (0, 1-2, and ≥3 instances). Multivariable logistic regressions were conducted to examine the clinical and sociodemographic predictors of experiencing financial hardship (0-2 vs ≥3 instances). Results The intensity of financial hardship did not significantly differ between survivors and siblings. Survivors reported more instances of material hardship than siblings (1-2 instances: 27.2% of survivors vs 22.6% of siblings; ≥3 instances: 15.9% of survivors vs 11.4% siblings; overall P = .03). In multivariable regressions, insurance was protective against all domains of financial hardship (behavioral odds ratio [OR], 0.12; 95% confidence interval [CI], 0.06-0.22; material OR, 0.37; 95% CI, 0.19-0.71; psychological OR, 0.10; 95% CI, 0.05-0.21). Survivors who were older at diagnosis, female, and with chronic health conditions generally had higher levels of hardship. Brain radiation and alkylating agents were associated with higher levels of hardship. Conclusions Material, behavioral, and psychological financial burden among survivors of childhood cancer is common.

BACKGROUND Patient-reported outcomes (PROs) assessing quality of life (QOL) and symptom burden correlate with clinical outcomes in patients with cancer. However, to the authors' knowledge, data regarding associations between PROs and treatment response are lacking. METHODS The authors prospectively approached consecutive patients with advanced gastrointestinal cancer who were initiating a new treatment. Prior to treatment, patients reported their QOL (Functional Assessment of Cancer Therapy-General [FACT-G], 4 subscales: Functional, Physical, Emotional, Social; higher scores indicate better QOL) and symptom burden (Edmonton Symptom Assessment System [ESAS], Patient Health Questionnaire-4 [PHQ-4]; higher scores represent greater symptoms). Regression models were used to examine associations of baseline PROs with treatment response (clinical benefit or progressive disease [PD] at time of first scan), healthcare utilization, and survival. RESULTS From May 2019 to April 2020, a total of 112 patients with advanced gastrointestinal cancer were enrolled. For treatment response, 64.3% had CB and 35.7% had PD. Higher baseline ESAS-Physical (odds ratio, 1.04; P = .027) and lower FACT-G Functional (odds ratio, 0.92; P = .038) scores were associated with PD. Higher ESAS-Physical (hazard ratio [HR], 1.03; P = .044) and lower FACT-G Total (HR, 0.96; P = .005), FACT-G Physical (HR, 0.89; P < .001), and FACT-G Functional (HR, 0.87; P < .001) scores were associated with a greater hospitalization risk. Lower FACT-G Total (HR, 0.96; P = .009) and FACT-G Emotional (HR, 0.86; P = .012) scores as well as higher ESAS-Total (HR, 1.03; P = .014) and ESAS-Physical (HR, 1.04; P = .032) scores were associated with worse survival. CONCLUSIONS Baseline PROs are associated with treatment response in patients with advanced gastrointestinal cancer, namely physical symptoms and functional QOL, in addition to health care use and survival. The findings of the current study support the association between PROs and important clinical outcomes, including the novel finding of treatment response.

BACKGROUND Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse. METHODS The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use. RESULTS Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P

Background Shared decision-making (SDM) occurs when a patient partners with their oncologist to integrate personal preferences and values into treatment decisions. A key component of SDM is the elicitation of patient preferences and values, yet little is known about how and when these are elicited, communicated, prioritized, and documented within clinical encounters. Methods This cross-sectional study evaluated nationwide data collected by CancerCare to better understand current patterns of SDM between patients and their oncology clinicians. Patient surveys included questions about the importance of quality-of-life preferences and discussions regarding quality-of-life priorities with their clinicians. Clinician surveys included questions about the discussion of quality-of-life priorities and preferences with patients, the effect of quality-of-life priorities on treatment recommendations, and quality-of-life priority documentation in practice. Results Patient survey completers (n = 320; 33% response rate) were predominantly women (95%), had a diagnosis of breast cancer (59%), or were receiving active cancer treatment (59%). Clinician survey completers (n = 112; 5% response rate) predominately identified as hematologists or oncologists (66%). Although 67% of clinicians reported knowing their patients' personal quality-of-life priorities and preferences before finalizing treatment plans, only 37% of patients reported that these discussions occurred before treatment initiation. Most patients (95%) considered out-of-pocket expenses important during treatment planning, yet only 59% reported discussing out-of-pocket expenses with their clinician before finalizing treatment plans. A majority of clinicians (52%) considered clinic questionnaires as feasible to document quality-of-life priorities and preferences. Conclusions Patients and clinicians reported that preferences related to quality-of-life should be considered in treatment decision making, yet barriers to SDM, preference elicitation, and documentation remain.

BACKGROUND This study examined factors associated with potentially burdensome end-of-life (EOL) transitions between care settings among older adults with advanced cancer in nursing homes (NHs). METHODS A retrospective analysis of deceased older NH residents with poor-prognosis solid tumors was conducted with Medicare claims and the Minimum Data Set. A potentially burdensome transition was defined as 2 or more hospitalizations or an intensive care unit admission in the last 90 days of life. RESULTS Among 34,670 subjects, many had moderate to severe cognitive impairment (53.8%), full dependence in activities of daily living (ADLs; 66.5%), and comorbidities such as congestive heart failure (CHF; 29.3%) and chronic obstructive pulmonary disease (34.1%). Only 56.3% of the patients used hospice at any time in the 90 days before death; 36.0% of the patients experienced a potentially burdensome EOL transition, and this was higher among patients who did not receive hospice (45.4% vs 28.7%; P

BACKGROUND Patients with cancer experience many stressors placing them at risk for posttraumatic stress disorder (PTSD) symptoms, yet little is known about factors associated with PTSD symptoms in this population. This study explored relationships among patients' PTSD symptoms, physical and psychological symptom burden, and risk for hospital readmissions. METHODS We prospectively enrolled patients with cancer admitted for an unplanned hospitalization from August 2015-April 2017. Upon admission, we assessed patients' PTSD symptoms (Primary Care PTSD Screen), as well as physical (Edmonton Symptom Assessment System [ESAS]) and psychological (Patient Health Questionnaire 4 [PHQ-4]) symptoms. We examined associations between PTSD symptoms and patients' physical and psychological symptom burden using linear regression. We evaluated relationships between PTSD symptoms and unplanned hospital readmissions within 90-days using Cox regression. RESULTS We enrolled 954 of 1,087 (87.8%) patients approached, and 127 (13.3%) screened positive for PTSD symptoms. The 90-day hospital readmission rate was 38.9%. Younger age, female sex, greater comorbidities, and genitourinary cancer type were associated with higher PTSD scores. Patients' PTSD symptoms were associated with physical symptoms (ESAS physical: B = 3.41; P

BACKGROUND Patients with advanced cancer often experience frequent and prolonged hospitalizations; however, the factors associated with greater health care utilization have not been described. We sought to investigate the relation between patients' physical and psychological symptom burden and health care utilization. METHODS We enrolled patients with advanced cancer and unplanned hospitalizations from September 2014-May 2016. Upon admission, we assessed physical (Edmonton Symptom Assessment System [ESAS]) and psychological symptoms (Patient Health Questionnaire 4 [PHQ-4]). We examined the relationship between symptom burden and healthcare utilization using linear regression for hospital length of stay (LOS) and Cox regression for time to first unplanned readmission within 90 days. We adjusted all models for age, sex, marital status, comorbidity, education, time since advanced cancer diagnosis, and cancer type. RESULTS We enrolled 1,036 of 1,152 (89.9%) consecutive patients approached. Over one-half reported moderate/severe fatigue, poor well being, drowsiness, pain, and lack of appetite. PHQ-4 scores indicated that 28.8% and 28.0% of patients had depression and anxiety symptoms, respectively. The mean hospital LOS was 6.3 days, and the 90-day readmission rate was 43.1%. Physical symptoms (ESAS: unstandardized coefficient [B], 0.06; P < .001), psychological distress (PHQ-4 total: B, 0.11; P = .040), and depression symptoms (PHQ-4 depression: B, 0.22; P = .017) were associated with longer hospital LOS. Physical (ESAS: hazard ratio, 1.01; P < .001), and anxiety symptoms (PHQ-4 anxiety: hazard ratio, 1.06; P = .045) were associated with a higher likelihood for readmission. CONCLUSIONS Hospitalized patients with advanced cancer experience a high symptom burden, which is significantly associated with prolonged hospitalizations and readmissions. Interventions are needed to address the symptom burden of this population to improve health care delivery and utilization. Cancer 2017;123:4720-4727. © 2017 American Cancer Society.

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.

BACKGROUND Although hospitalized patients with advanced cancer have a low chance of surviving cardiopulmonary resuscitation (CPR), the processes by which they change their code status from full code to do not resuscitate (DNR) are unknown. METHODS We conducted a mixed-methods study on a prospective cohort of hospitalized patients with advanced cancer. Two physicians used a consensus-driven medical record review to characterize processes that led to code status order transitions from full code to DNR. RESULTS In total, 1047 hospitalizations were reviewed among 728 patients. Admitting clinicians did not address code status in 53% of hospitalizations, resulting in code status orders of "presumed full." In total, 275 patients (26.3%) transitioned from full code to DNR, and 48.7% (134 of 275 patients) of those had an order of "presumed full" at admission; however, upon further clarification, the patients expressed that they had wished to be DNR before the hospitalization. We identified 3 additional processes leading to order transition from full code to DNR acute clinical deterioration (15.3%), discontinuation of cancer-directed therapy (17.1%), and education about the potential harms/futility of CPR (15.3%). Compared with discontinuing therapy and education, transitions because of acute clinical deterioration were associated with less patient involvement (P = .002), a shorter time to death (P < .001), and a greater likelihood of inpatient death (P = .005). CONCLUSIONS One-half of code status order changes among hospitalized patients with advanced cancer were because of full code orders in patients who had a preference for DNR before hospitalization. Transitions due of acute clinical deterioration were associated with less patient engagement and a higher likelihood of inpatient death. Cancer 2017;123:4895-902. © 2017 American Cancer Society.

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.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.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.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.