Addressing distress management challenges: Recommendations from the consensus panel of the American Psychosocial Oncology Society and the Association of Oncology Social Work.

Distress management (DM) (screening and response) is an essential component of cancer care across the treatment trajectory. Effective DM has many benefits, including improving patients' quality of life; reducing distress, anxiety, and depression; contributing to medical cost offsets; and reducing emergency department visits and hospitalizations. Unfortunately, many distressed patients do not receive needed services. There are several multilevel barriers that represent key challenges to DM and affect its implementation. The Consolidated Framework for Implementation Research was used as an organizational structure to outline the barriers and facilitators to implementation of DM, including: 1) individual characteristics (individual patient characteristics with a focus on groups who may face unique barriers to distress screening and linkage to services), 2) intervention (unique aspects of DM intervention, including specific challenges in screening and psychosocial intervention, with recommendations for resolving these challenges), 3) processes for implementation of DM (modality and timing of screening, the challenge of triage for urgent needs, and incorporation of patient-reported outcomes and quality measures), 4) organization-inner setting (the context of the clinic, hospital, or health care system); and 5) organization-outer setting (including reimbursement strategies and health-care policy). Specific recommendations for evidence-based strategies and interventions for each of the domains of the Consolidated Framework for Implementation Research are also included to address barriers and challenges.

Financial toxicity in early-phase cancer clinical trial participants.

BACKGROUND: Little is known about financial toxicity in early-phase clinical trial (EP-CT) participants. This study sought to describe financial toxicity in EP-CT participants and assess associations with patient characteristics and patient-reported outcomes (PROs). METHODS: Prospectively enrolled EP-CT participants from were followed from April 2021 through January 2023. Participants completed the Comprehensive Score for Financial Toxicity (<26 = financial toxicity) at time of treatment. Quality of life (QOL), symptoms, coping, and resource concerns were surveyed. Associations of financial toxicity with patient characteristics, PROs, and clinical outcomes were explored. RESULTS: Of 261 eligible patients, 197 completed baseline assessments (75.5%, median age = 63.4 years [31.8-88.6], 57.4% female). Most common cancers were gastrointestinal (33.0%) and breast (20.8%). More than one third (34.0%) of patients reported financial toxicity. Patients with financial toxicity were more likely to be <65 years (70.2% vs 48.5%, p = .004), unemployed (45.5% vs 16.9%, p < .001), not have attended college (53.1% vs 26.4%, p = .002), and have income <$60,000 (59.7% vs 25.4%, p < .001). In adjusted models, patients with financial toxicity reported lower QOL (B = -6.66, p = .004) and acceptance (B = -0.78, p = .002), and increased self-blame (B = 0.87, p < .001). They were more likely to have concerns regarding housing (10.6% vs 2.3%, p = .025), bills (31.8% vs 3.8%, p < .001), food (9.1% vs 0.8%, p = .006), and employment (21.2% vs 1.5%, p < .001). There was no difference in time on trial (hazard ratio, 1.03; p = .860) or survival (hazard ratio, 1.16; p = .496). CONCLUSIONS: More than one third of EP-CT participants reported financial toxicity. Factors associated with financial toxicity and demonstrated novel associations among financial toxicity with QOL, coping, and resource concerns were identified, highlighting the need to address financial toxicity among this population.

Oncology drug pricing: potential Medicare savings on cancer-directed and supportive care medications through the Mark Cuban cost plus drug model.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n = 7) and supportive care (n = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings.

National survey of patient perspectives on cost discussions among recipients of copay assistance.

BACKGROUND: Individuals with cancer and other medical conditions often experience financial concerns from high costs-of-care and may utilize copay assistance programs (CAP). We sought to describe CAP recipients' experiences/preferences for cost discussions with clinicians. METHODS: We conducted a national, cross-sectional electronic-survey from 10/2022 to 11/2022 of CAP recipients with cancer or autoimmune conditions to assess patient perspectives on cost discussions. We used multivariable logistic regression models to explore associations of patient perspectives on cost discussions with patient characteristics and patient-reported outcomes (eg, financial toxicity, depression/anxiety, and health literacy). RESULTS: Among 1,566 participants, 71% had cancer and 29% had autoimmune conditions. Although 62% of respondents desired cost discussions, only 32% reported discussions took place. Additionally, 52% of respondents wanted their doctor to consider out-of-pocket costs when deciding the best treatment, and 61% of respondents felt doctors should ensure patients can afford treatment prescribed. Participants with depression symptoms were more likely to want doctors to consider out-of-pocket costs (OR = 1.54, P = .005) and to believe doctors should ensure patients can afford treatment (OR = 1.60, P = .005). Those with severe financial toxicity were more likely to desire cost discussions (OR = 1.65, P < .001) and want doctors to consider out-of-pocket costs (OR = 1.52, P = .001). Participants with marginal/inadequate health literacy were more likely to desire cost discussions (OR = 1.37, P = .01) and believe doctors should ensure patients can afford treatment (OR = 1.30, P = .036). CONCLUSIONS: In this large sample of CAP recipients with cancer and autoimmune conditions, most reported a desire for cost discussions, but under one-third reported such discussions took place.

Telemedicine-based serious illness conversations, healthcare utilization, and end of life care among patients with advanced lung cancer.

PURPOSE: Little is known about serious illness conversations (SIC) conducted during telemedicine visits and their impact on end-of-life (EOL) outcomes for patients with advanced cancer. PATIENTS AND METHODS: We conducted a retrospective analysis telemedicine visits for patients with metastatic lung cancer conducted during the first surge of the COVID-19 pandemic (October 3, 2020-October 6, 2020). We used natural language processing (NLP) to characterize documentation of SIC domains (ie, goals of care [GOC], limitation of life-sustaining treatment [LLST], prognostic awareness [PA], palliative care [PC], and hospice). We used unadjusted logistic regression to evaluate factors associated with SIC documentation and the relationship between SIC documentation and EOL outcomes. RESULTS: The study included 634 telemedicine visits across 360 patients. Documentation of at least one SIC domain was present in 188 (29.7%) visits with GOC and PA being the most discussed domains. Family presence (odds ratio [OR], 1.66; P = .004), progressive or newly diagnosed disease (OR, 5.42; P < .000), age ≥ 70 (OR, 1.80; P = .009), and male sex (OR, 2.23; P < .000) were associated with a greater likelihood of discussing ≥ 1 SIC domain. Of the 61 patients who died within 12 months of the study period, having ≥ 1 SIC domain discussed was associated with a lower likelihood of hospitalization in the last 30 days of life (OR, 0.27; P = .020). CONCLUSION: In this study of telehealth visits, we identified important factors associated with an increased likelihood of having documentation of an SIC and demonstrated that SIC documentation correlated with lower likelihood of hospitalization at EOL.

Financial burden following adult liver transplantation is common and associated with adverse recipient outcomes.

The financial impact of liver transplantation has been underexplored. We aimed to identify associations between high financial burden (≥10% annual income spent on out-of-pocket medical costs) and work productivity, financial distress (coping behaviors in response to the financial burden), and financial toxicity (health-related quality of life, HRQOL) among adult recipients of liver transplant. Between June 2021 and May 2022, we surveyed 207 adult recipients of liver transplant across 5 US transplant centers. Financial burden and distress were measured by 25 items adapted from national surveys of cancer survivors. Participants also completed the Work Productivity and Activity Impairment and EQ-5D-5L HRQOL questionnaires. In total, 23% of recipients reported high financial burden which was significantly associated with higher daily activity impairment (32.9% vs. 23.3%, p =0.048). In adjusted analyses, the high financial burden was significantly and independently associated with delayed or foregone medical care (adjusted odds ratio, 3.95; 95% CI, 1.85-8.42) and being unable to afford basic necessities (adjusted odds ratio, 5.12; 95% CI: 1.61-16.37). Recipients experiencing high financial burden had significantly lower self-reported HRQOL as measured by the EQ-5D-5L compared to recipients with low financial burden (67.8 vs. 76.1, p =0.008) and an age-matched and sex-matched US general population (67.8 vs. 79.1, p <0.001). In this multicenter cohort study, nearly 1 in 4 adult recipients of liver transplant experienced a high financial burden, which was significantly associated with delayed or foregone medical care and lower self-reported HRQOL. These findings underscore the need to evaluate and address the financial burden in this population before and after transplantation.

Health Care Lobbying and Oncology.

BACKGROUND: The health care industry spends more on lobbying than any other industry, with more than $700 million spent in 2022. However, health care lobbying related to cancer has not been characterized. In this study, we sought to describe overall health sector lobbying spending and oncology-related lobbying spending across patient and clinician organizations. METHODS: We obtained lobbying data from OpenSecrets.org and the Federal Election Commission. Overall health sector lobbying spending was categorized by OpenSecrets into 4 groups: pharmaceuticals/health products, health services/health maintenance organizations (HMOs), hospitals/nursing homes, and health professionals. We then identified and categorized 4 oncology-related lobbying groups: oncology physician professional organizations (OPPOs), prospective payment system (PPS)-exempt cancer hospitals, patient advocacy organizations, and provider networks (eg, US Oncology Network). We described temporal trends in lobbying spending from 2014 to 2022, in both overall dollar value (inflation-adjusted 2023 dollars) and in per-physician spending (using American Association of Medical Colleges [AAMC] data for number of hematologists/oncologists) using a Mann-Kendall trend test. RESULTS: Among the overall health sector lobbying, pharmaceuticals/health products had the greatest increase in lobbying spending, with an increase from $294 million in 2014 to >$376 million in 2022 (P=.0006). In contrast, lobbying spending by health professionals did not change, remaining at $96 million (P=.35). Regarding oncology-related lobbying, OPPOs and PPS-exempt cancer hospitals had a significant increase of 170% (P=.016) and 62% (P=.009), respectively. Per-physician spending also demonstrated an increase from $60 to $134 for OPPOs and from $168 to $226 for PPS-exempt cancer hospitals. Overall, OPPO lobbying increased as a percentage of overall physician lobbying from 1.16% in 2014 to 3.76% in 2022. CONCLUSIONS: Although overall health sector lobbying has increased, physician/health professional lobbying has remained relatively stable in recent years, spending for lobbying by OPPOs has increased. Continued efforts to understand the utility and value of lobbying in health care and across oncology are needed as the costs of care continue to increase.

Development and multicentre validation of the FLEX score: personalised preoperative surgical risk prediction using attention-based ICD-10 and Current Procedural Terminology set embeddings.

BACKGROUND: Preoperative knowledge of surgical risks can improve perioperative care and patient outcomes. However, assessments requiring clinician examination of patients or manual chart review can be too burdensome for routine use. METHODS: We conducted a multicentre retrospective study of 243 479 adult noncardiac surgical patients at four hospitals within the Mass General Brigham (MGB) system in the USA. We developed a machine learning method using routinely collected coding and patient characteristics data from the electronic health record which predicts 30-day mortality, 30-day readmission, discharge to long-term care, and hospital length of stay. RESULTS: Our method, the Flexible Surgical Set Embedding (FLEX) score, achieved state-of-the-art performance to identify comorbidities that significantly contribute to the risk of each adverse outcome. The contributions of comorbidities are weighted based on patient-specific context, yielding personalised risk predictions. Understanding the significant drivers of risk of adverse outcomes for each patient can inform clinicians of potential targets for intervention. CONCLUSIONS: FLEX utilises information from a wider range of medical diagnostic and procedural codes than previously possible and can adapt to different coding practices to accurately predict adverse postoperative outcomes.

The Use of Natural Language Processing to Assess Social Support in Patients With Advanced Cancer.

BACKGROUND: Data examining associations among social support, survival, and healthcare utilization are lacking in patients with advanced cancer. METHODS: We conducted a cross-sectional secondary analysis using data from a prospective longitudinal cohort study of 966 hospitalized patients with advanced cancer at Massachusetts General Hospital from 2014 through 2017. We used NLP to identify extent of patients' social support (limited versus adequate as defined by NLP-aided review of the Electronic Health Record (EHR)). Two independent coders achieved a Kappa of 0.90 (95% CI: 0.84-1.00) using NLP. Using multivariable regression models, we examined associations of social support with: 1) OS; 2) death or readmission within 90 days of hospital discharge; 3) time to readmission within 90 days; and 4) hospital length of stay (LOS). RESULTS: Patients' median age was 65 (range: 21-92) years, and a plurality had gastrointestinal (GI) cancer (34.3%) followed by lung cancer (19.5%). 6.2% (60/966) of patients had limited social support. In multivariable analyses, limited social support was not significantly associated with OS (HR = 1.13, P = 0.390), death or readmission (OR = 1.18, P = 0.578), time to readmission (HR = 0.92, P = 0.698), or LOS (ß = -0.22, P = 0.726). We identified a potential interaction suggesting cancer type (GI cancer versus other) may be an effect modifier of the relationship between social support and OS (interaction term P = 0.053). In separate unadjusted analyses, limited social support was associated with lower OS (HR = 2.10, P = 0.008) in patients with GI cancer but not other cancer types (HR = 1.00, P = 0.991). CONCLUSION: We used NLP to assess the extent of social support in patients with advanced cancer. We did not identify significant associations of social support with OS or healthcare utilization but found cancer type may be an effect modifier of the relationship between social support and OS. These findings underscore the potential utility of NLP for evaluating social support in patients with advanced cancer.

Qualitative study of Oncology Clinicians' Perceptions of Barriers to Offering Clinical Trials to Underserved Populations.

INTRODUCTION: Cancer clinical trials represent the "gold standard" for advancing novel cancer therapies. Optimizing trial participation is critical to ensuring the generalizability of findings across patients, yet trial enrollment rates, particularly among minority and socioeconomically disadvantaged populations, remain suboptimal. METHODS: We conducted in-depth interviews with oncologists at a large academic medical center to explore their (1) attitudes and perceived barriers to offering clinical trials to minority and socioeconomically disadvantaged patients, and (2) recommendations for improving the enrollment of minority and socioeconomically disadvantaged patients in cancer clinical trials. RESULTS: Of 23 medical oncologists approached, 17 enrolled (74% response rate; mean age = 47; female = 42%; White = 67%). Content analysis revealed several barriers to enrollment: (1) ethical dilemmas; (2) ambivalence about trial risks and benefits; and (3) concern about patient well-being. Concerns about the legitimacy of informed consent, perceived lack of equipoise, and fear of personal bias influenced clinicians' decisions to recommend trials during treatment discussions. Concerns about creating an imbalance between trial risks and benefits among patients with high-level needs, including patients with literacy, psychiatric, and other socioeconomic vulnerabilities, impacted clinicians' enthusiasm to engage in trial discussions. Clinicians identified patient, provider, and system-level solutions to address challenges, including increasing patient and clinician support as well as involving external personnel to support trial enrollment. CONCLUSION: Findings reveal multi-level barriers to offering cancer clinical trials to underrepresented patients. Targeted solutions, including system level changes to support clinicians, patient financial support, and implementation of clinical trial navigation programs were recommended to help reduce access barriers and increase enrollment of underrepresented patients into cancer clinical trials.

Association of atrial fibrillation and outcomes in patients undergoing bone marrow transplantation.

AIMS: Haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy for several malignant and non-malignant haematologic conditions. Patients undergoing HSCT are at an increased risk of developing atrial fibrillation (AF). We hypothesized that a diagnosis of AF would be associated with poor outcomes in patients undergoing HSCT. METHODS AND RESULTS: The National Inpatient Sample (2016-19) was queried with ICD-10 codes to identify patients aged >50 years undergoing HSCT. Clinical outcomes were compared between patients with and without AF. A multivariable regression model adjusting for demographics and comorbidities was used to calculate the adjusted odds ratio (aOR) and regression coefficients with corresponding 95% confidence intervals and P-values. A total of 50 570 weighted hospitalizations for HSCT were identified, out of which 5820 (11.5%) had AF. Atrial fibrillation was found to be independently associated with higher inpatient mortality (aOR 2.75; 1.9-3.98; P < 0.001), cardiac arrest (aOR 2.86; 1.55-5.26; P = 0.001), acute kidney injury (aOR 1.89; 1.6-2.23; P < 0.001), acute heart failure exacerbation (aOR 5.01; 3.54-7.1; P < 0.001), cardiogenic shock (aOR 7.73; 3.17-18.8; P < 0.001), and acute respiratory failure (aOR 3.24; 2.56-4.1; P < 0.001) as well as higher mean length of stay (LOS) (+2.67; 1.79-3.55; P < 0.001) and cost of care (+67 529; 36 630-98 427; P < 0.001). CONCLUSION: Among patients undergoing HSCT, AF was independently associated with poor in-hospital outcomes, higher LOS, and cost of care.

Fertility preservation in reproductive-aged female patients with colorectal cancer: a scoping review.

BACKGROUND: Colorectal cancer (CRC) incidence in adults younger than 50 years is steadily increasing in the USA, and treatment for CRC can impact future fertility. However, fertility decision-making in female patients with CRC can be complex, with fertility preservation (FP) counseling occurring inconsistently. PURPOSE: The goal of this scoping review was to assess the literature regarding the frequency and quality of fertility preservation (FP) discussions taking place among oncology clinicians and their reproductive-age female patients with colorectal cancer (CRC) in order to identify existing gaps in care and inform future research, interventions, or potential changes in practice. METHODS: A comprehensive literature search was conducted using the Ovid Medline, PsycInfo, and Scopus databases in order to identify studies pertaining to FP counseling in reproductive-age female patients with CRC. We used Covidence to screen studies for relevance and to extract data. Findings of interest included rate of fertility and/or FP discussions, patient characteristics associated with fertility discussions, initiators of discussions, rate of referrals to fertility specialists, patient utilization of FP services, and unmet fertility needs. We performed both quantitative and qualitative data synthesis. RESULTS: We identified five studies that met our inclusion criteria, all published between 2007 and 2022. Frequency of fertility counseling discussions was low across studies, with a range of 15 to 52.5% of female patients with CRC receiving counseling. Patient characteristics which may be associated with likelihood of fertility discussion included age, parity, number of children, cancer location and stage, treatment type, and quality of life. The literature suggested that fertility discussions were initiated by clinicians about two-thirds of the time, and medical oncologists were the clinicians most likely to initiate. Studies did capture unmet fertility-related patient needs; participants who did not receive counseling often expressed desire for these discussions and regret that they did not occur. CONCLUSION: Despite increasing incidence of CRC in patients at younger ages, this scoping review found a dearth of research conducted on young female CRC patients' experiences with fertility counseling and referrals. Notably, the existing research reveals that relatively few of these patients are receiving appropriate counseling. Additional research is needed to clarify current FP counseling practices, patient and clinician perceptions about FP, and ways to improve the quantity and quality of FP counseling in this patient population.

Perceptions of prognosis and end-of-life care outcomes in patients with advanced lung and gastrointestinal cancer.

BACKGROUND: Many patients with advanced cancer have misperceptions of their prognosis, which may impact end-of-life decision-making. Data regarding associations between prognostic perceptions over time and end-of-life care outcomes are lacking. AIM: To describe patients' perceptions of their prognosis with advanced cancer and examine associations between these perceptions and end-of-life care outcomes. DESIGN: Secondary analysis of longitudinal data from a randomized controlled trial of a palliative care intervention for patients with newly diagnosed incurable cancer. SETTING/PARTICIPANTS: Conducted at an outpatient cancer center in the northeastern United States and patients were within 8 weeks of a diagnosis with incurable lung or non-colorectal gastrointestinal cancer. RESULTS: We enrolled 350 patients in the parent trial, of which 80.5% (281/350) died during the study period. Overall, 59.4% (164/276) of patients reported they were terminally ill, and 66.1% (154/233) reported that their cancer was likely curable at the assessment closest to death. Patient acknowledgment of terminal illness was only associated with lower risk of hospitalizations in the last 30 days of life (OR = 0.52, p = 0.025). Patients who reported their cancer as likely curable were less likely to utilize hospice (OR = 0.25, p = 0.002) or die at home (OR = 0.56, p = 0.043), and they were more likely to be hospitalized in the last 30 days of life (OR = 2.28, p = 0.011). CONCLUSIONS: Patients' perceptions of their prognosis are associated with important end-of-life care outcomes. Interventions are needed to enhance patients' perceptions of their prognosis and optimize their end-of-life care.

Immune Checkpoint Inhibitors: The Unexplored Landscape of Geriatric Oncology.

Cancer is classically considered a disease of aging, with over half of all new cancer diagnoses occurring in patients over the age of 65 years. Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, yet the participation of older adults with cancer in ICI trials has been suboptimal, particularly at the extremes of age. Despite significant improvement in treatment response and an improved toxicity profile when compared with conventional cytotoxic chemotherapies, many cancers develop resistance to ICIs, and these drugs are not free of toxicities. This becomes particularly important in the setting of older adults with cancer, who are generally frailer and harbor more comorbidities than do their younger counterparts. Immunosenescence, a concept involving age-related changes in immune function, may also play a role in differential responses to ICI treatment in older patients. Data on ICI treatment response in older adult with cancers remains inconclusive, with multiple studies revealing conflicting results. The molecular mechanisms underlying response to ICIs in older cancer patients are poorly understood, and predictors of response that can delineate responders from non-responders remain to be elucidated. In this review, we explore the unique geriatric oncology population by analyzing existing retrospective datasets, and we also sought to highlight potential cellular, inflammatory, and molecular changes associated with aging as potential biomarkers for response to ICIs.

Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer.

BACKGROUND: Patients with cancer often endure substantial symptoms and treatment toxicities leading to high healthcare utilization, including hospitalizations and emergency department visits, throughout the continuum of their illness. Innovative oncology care models are needed to improve patient outcomes and reduce their healthcare utilization. Using a novel hospital at home care platform, we developed a Supportive Oncology Care at Home intervention to address the needs of patients with cancer. METHODS: We are conducting three trials to delineate the role of Supportive Oncology Care at Home for patients with cancer. The Supportive Oncology Care at Home intervention includes: (1) a hospital at home care model for symptom assessment and management; (2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and (3) structured communication with the oncology team. Our first study is a randomized controlled trial to test the efficacy of Supportive Oncology Care at Home versus standard oncology care for improving healthcare utilization, cancer treatment interruptions, and patient-reported outcomes in patients with cancer receiving definitive treatment of their cancer. Participants include adult patients with gastrointestinal and head and neck cancer, as well as lymphoma, receiving definitive treatment (e.g., treatment with curative intent). The second study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention for hospitalized patients with advanced cancer. Eligible participants include adult patients with incurable cancer who are admitted with an unplanned hospitalization. The third study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention to enhance the end-of-life care for patients with advanced hematologic malignancies. Eligible participants include adult patients with relapsed or refractory hematologic malignancy receiving palliative therapy or supportive care alone. DISCUSSION: These studies are approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and are being conducted in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. This work has the potential to transform the paradigm of care for patients with cancer by providing them with the necessary support at home to improve their health outcomes and care delivery. TRIAL REGISTRATIONS: NCT04544046, NCT04637035, NCT04690205.

Representation and Outcomes of Older Adults in Practice-Changing Oncology Trials in the Era of Novel Therapies: A Guideline Appraisal.

BACKGROUND: Older adults account for 70% of cancer-related deaths, but previous studies have shown that they are underrepresented in cancer clinical trials. We sought to analyze the representation and outcomes of older adults in trials conducted in the era of novel targeted therapy and immunotherapy. METHODS: We searched the 2020 NCCN Clinical Practice Guidelines in Oncology and retrieved trials from the past 10 years leading to category 1 recommendations in the first-line metastatic setting for the 5 most common causes of cancer death. We categorized trials by cancer type, single-agent versus multiagent approach, and therapeutic class. We described the percentage of older adults (according to each trial's definition) and used a Mantel-Haenszel random-effects meta-analysis model to compare overall and progression-free survival by age. RESULTS: We identified 30 trials consisting of 24,416 patients. Across all trials, 44% of enrolled patients were older adults. Representation of older adults by cancer type within trials was 49% prostate cancer, 38% pancreatic cancer, 37% breast cancer, and 34% non-small cell lung cancer. Representation of older adults also varied by therapeutic class: 20% received immunotherapy, 44% received cytotoxic chemotherapy, 54% received targeted/hormonal therapy, and 34% received combination therapy (P<.001 for all comparisons). For each year since 2010, the percentage of older adults enrolled in trials increased by 1.9%, although this difference was not significant. We observed no difference in overall or progression-free survival between older and younger adults. In our analysis of practice-changing clinical trials, we found that 44% of clinical trial participants were older adults. Trials that included immunotherapy or a combination of therapeutic classes had a lower representation of older adults (<40%). CONCLUSIONS: We found that >40% of patients in practice-changing trials are older adults. Although they remain underrepresented in clinical trials compared with the general population, older adults in practice-changing trials seem to be better represented than in previously reported analyses of cooperative group trials.

Associations of patient-reported care satisfaction with symptom burden and healthcare use in hospitalized patients with cancer.

BACKGROUND: Hospitalized patients with cancer often experience a high symptom burden, which may impact care satisfaction and healthcare utilization. METHODS: We prospectively enrolled patients with cancer and unplanned hospitalizations from September 2014 to April 2017. Upon admission, we assessed patients' care satisfaction (FAMCARE items: satisfaction with care coordination and speed with which symptoms are treated) and physical (Edmonton Symptom Assessment System [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms. We used regression models to identify factors associated with care satisfaction and associations of satisfaction with symptom burden and hospital length of stay (LOS). RESULTS: Among 1,576 participants, most reported being "satisfied"/ "very satisfied" with care coordination (90%) and speed with which symptoms are treated (89%). Older age (coordination: B < 0.01, P = 0.02, speed: B = 0.01, P < 0.01) and admission to a dedicated oncology service (B = 0.20, P < 0.01 for each) were associated with higher satisfaction. Higher satisfaction with care coordination was associated with lower ESAS-physical (B = - 1.28, P < 0.01), ESAS-total (B = - 2.73, P < 0.01), PHQ4-depression (B = - 0.14, P = 0.02), and PHQ4-anxiety (B = - 0.16, P < 0.01) symptoms. Higher satisfaction with speed with which symptoms are treated was associated with lower ESAS-physical (B = - 1.32, P < 0.01), ESAS-total (B = - 2.46, P < 0.01), PHQ4-depression (B = - 0.14, P = 0.01), and PHQ4-anxiety (B = - 0.17, P < 0.01) symptoms. Satisfaction with care coordination (B = - 0.48, P = 0.04) and speed with which symptoms are treated (B = - 0.44, P = 0.04) correlated with shorter LOS. CONCLUSIONS: Hospitalized patients with cancer report high care satisfaction, which correlates with older age and admission to a dedicated oncology service. Significant associations among higher care satisfaction, lower symptom burden, and shorter hospital LOS highlight the importance of improving symptom management and care coordination in this population.

Disparities in phase 1 cancer clinical trial enrollment.

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.

Material, behavioral, and psychological financial hardship among survivors of childhood cancer in the Childhood Cancer Survivor Study.

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.

Associations of baseline patient-reported outcomes with treatment outcomes in advanced gastrointestinal cancer.

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.