PURPOSE Participation in clinical trials imposes additional time commitments beyond routine care; however, trial-associated time toxicity (TT) remains underinvestigated and poorly characterized. The purpose of this study was to develop a scalable, procedure-based metric to quantify total time required for trial participation using the protocol schedule of events. We applied this framework to lung cancer clinical trials to estimate trial-associated burden and explore changes in TT over time. MATERIALS AND METHODS Protocols for clinical trials associated with United States (US) Food and Drug Administration (FDA) approvals of oral lung cancer therapies were obtained from public sources. Using each protocol's schedule of events, study-mandated procedures were assigned time toxicity units (TTUs) based on standardized time estimates. TTUs for each procedure were multiplied by their frequency and summed for screening through cycle 5 to determine a trial's total time toxicity (TTT). Days with health care contact (DHC) were summed over the same period to determine total DHC (TDHC). Median (m) TTT and TDHC were compared between studies published in 2005-2014 and 2015-2024 to assess temporal trends. Two-sample Mann-Whitney U tests were used for nonparametric comparisons. RESULTS Thirty-two phase-specific protocols from trials published between 2005 and 2024 were included. Among studies published in 2005-2014 (n = 7), the median TTT (mTTT) was 63.8 (41.8-109.3) versus 82 (50.3-139.5) in 2015-2024 (n = 25) ( P = .042). Corresponding median TDHC values were 14 (10-21) versus 15 (11-44), respectively ( P = .16). CONCLUSION More contemporary studies demonstrated higher TTT, with significantly greater mTTT observed in studies published in 2015-2024 versus 2005-2014. TDHC demonstrated less sensitivity in capturing differences in time burden. These findings demonstrate the feasibility and practical applicability of the proposed TT framework for characterizing protocol-associated time burden. Prospective validation and broader implementation may help inform patients and encourage streamlined protocol development.
PURPOSE:Oncologists struggle to know which patients are near end of life to enable timely transitions to supportive care. We developed an electronic health record-based prognostic model to identify patients with metastatic breast cancer (MBC) at high risk of near-term death. METHODS:For model development, we identified patients with MBC in CancerLinQ Discovery, 2000-2020. We randomly selected one encounter per patient, allocating encounters to training (70%) and test (30%) data sets. We evaluated candidate predictors of death within 30 and 90 days using logistic regression, including age, vital signs, laboratory values, performance status, time since last chemotherapy, and tumor phenotype. We varied the alert rate (ie, high-risk proportion) from 5% to 40% and evaluated performance for 30- and 90-day outcomes at each rate. We conducted external validation using an integrated health system database. RESULTS:We identified 9,270 patients with MBC. Significant predictors of mortality were lower sodium, albumin, or pulse oximetry; higher alkaline phosphatase, aspartate transaminase, white blood cell count, creatinine, or pulse rate; decrease in body mass; poor performance status; opioid use; and recent chemotherapy discontinuation. For 90-day mortality, in the internal test set, models had a prediction accuracy of 72%-83% and a positive predictive value of 41%-76% with an AUC of 0.81. External validation revealed an AUC of 0.68 and a Brier score of 0.321 ± 0.027. CONCLUSION:Clinical variables can predict risk of death within 30 and 90 days for patients with MBC. Further validation and optimization studies are required to maximize clinical utility and acceptability before implementation.
PURPOSE To compare cancer survival in the United States during the past half century in adolescent and young adult (AYA) patients of age 15-39 years with younger and older patients. METHODS Annual survival data were obtained from 8 US SEER regions during 1975-2017 for AYAs, younger (age 0-14 years), and older (age 40-59 and ≥65 years) populations. The average annual percent change (AAPC) in 5-year relative survival was determined with and without deaths from HIV/AID-associated malignancies that compromised overall cancer survival in males during the HIV/AIDS epidemic of 1981-1998. Joinpoint analysis identified time trends and statistical significances. RESULTS During 1975-1997, the AAPC in 5-year relative survival in AYAs was 0.66 (95% CI, 0.63 to 0.69), which was less than that in both younger, age <15 years, 0.93 (95% CI, 0.82 to 1.05) and older, age 40-64 years, 1.12 (95% CI, 0.10 to 1.14) patients. Subsequently, the 2000-2017 AAPC in AYAs was 0.47 (95% CI, 0.45 to 0.49), which was greater than that in both younger, age <15 years, 0.40 (95% CI, 0.34 to 0.45) and older, age 40-64 years, 0.43 (95% CI, 0.42 to 0.44) patients. In males, whose overall cancer survival was seriously compromised by the HIV epidemic in the 1980s and 1990s, much of the overall progress occurred as a result of the epidemic's cessation. Excluding HIV-associated cancers, however, showed even greater progress than the results for males and females considered together. CONCLUSION While compared with younger and older patients with cancer, American AYAs had the slowest improvement in 5-year relative survival before 1998, they since have had a greater improvement rate. Much of this progress can be attributed to national efforts led by NCI-funded cooperative groups to focus on AYA oncology.
PURPOSE Enfortumab vedotin (EV) is indicated for treatment of locally advanced or metastatic urothelial carcinoma (la/mUC) as monotherapy and in combination with pembrolizumab (P). The ultra-elderly population, defined as patients aged at least 80 years, represents the minority of patients treated in prospective clinical trials with EV. This study examined the real-world toxicity profile, efficacy outcomes, and dosing strategies of EV-based therapies in ultra-elderly patients with la/mUC. MATERIALS AND METHODS This is a retrospective analysis of 29 patients with la/mUC, aged at least 80 years, who were initiated on EV or EV plus P. The primary study endpoint was incidence and severity of EV treatment-related adverse events (TRAEs). Selected secondary endpoints included incidence of up-front dose reduction of EV and associated TRAEs, objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), and median overall survival (mOS). RESULTS At least one EV-related TRAE was observed in 79.3% of patients, but no grade 4 or 5 toxicities were observed. Starting EV dose was 1.25 mg/kg in 20.7% of patients, 1.0 mg/kg in 48.3% of patients, 0.75 mg/kg in 17.2% of patients, and 0.5 mg/kg in 13.8% of patients, which was administered on days 1 and 8 out of a 21-day cycle. The ORR was 57.7% and the DCR was 88.5%. The mPFS and mOS were 7.82 and 11.6 months, respectively. This study is limited by its retrospective nature and limited sample size. CONCLUSION This study did not identify excessive or unexpected toxicity from EV-based regimens in the ultra-elderly population. TRAEs were less severe at lower starting doses of EV. The efficacy of EV-based therapies appears comparable with previously published prospective data, despite up-front EV dose reduction.
The global burden of cancer is significant, with millions of new diagnoses expected annually, necessitating highly coordinated and patient-centered care. To address workforce shortages, increasing case complexity, and high rates of clinician burnout, ASCO advocates for a transition from traditional physician-centric models to interdependent, multidisciplinary team-based care. This paper outlines the essential characteristics of high-functioning oncology teams, which include clearly defined roles and responsibilities, established leadership, effective communication, shared goals, accountability, and a culture of psychological safety. To optimize team workflows, visual tools such as swim lane diagrams are recommended to clearly delineate tasks across various professionals, including oncologists, advanced practice providers, nurses, pharmacists, and support staff, thereby preventing redundancy and improving efficiency. Successfully implementing optimal care teams directly contributes to practice health by fostering supportive environments that enhance job satisfaction, improve clinician retention, and mitigate burnout, which currently affects over half of the oncology workforce. However, significant systemic barriers hinder the optimization of these collaborative models. Challenges include declining reimbursement rates, burdensome utilization management policies such as prior authorizations, and a lack of organizational support for nonbillable collaborative time. Furthermore, the rapid integration of artificial intelligence introduces new complexities to team dynamics and workflows. Ultimately, sustaining optimal team-based oncology care requires ongoing re-evaluation of roles and strong partnerships between clinical and administrative leaders to ensure long-term practice health and improved patient experiences.
PURPOSE:Sleep disturbance is prevalent with chronic diseases and poor health. However, evidence evaluating these associations and their variation by cancer status remains limited. We sought to examine the association between sleep duration and mental and physical health measures by cancer history. METHODS:Adults participating in the Behavioral Risk Factor Surveillance System in 2018, 2020, and 2022 were included. Sleep duration was categorized as short (≤5 hours), recommended (6-8 hours), and long (≥9 hours); mental and physical health measures included depression history, fair/poor general health, frequent mental distress, and frequent physical distress (defined as >14 days/month). Multinomial regression estimated the association of sleep duration with measures stratified by cancer history. RESULTS:A total of 1,097,127 adults were included, representing a weighted population of 662,954,607 adults; 184,901 (11.6%) had a history of cancer. Cancer survivors had a higher adjusted relative risk ratio of short sleep (aRRR = 1.13; 95% CI, 1.09 to 1.18) and long sleep (aRRR = 1.22; 95% CI, 1.17 to 1.27). Among cancer survivors, 11.2% (n = 17,591) reported short sleep, 78.4% (n = 147,058) recommended sleep, and 10.5% (n = 20,252) long sleep. Among cancer survivors, compared with recommended sleep, short sleep was associated with higher odds of frequent mental distress (adjusted odds ratio [aOR] = 3.10; 95% CI, 2.83 to 3.39) and frequent physical distress (aOR = 2.58; 95% CI, 2.38 to 2.80). Long sleep was also associated with higher adjusted odds of frequent mental distress (aOR = 1.61; 95% CI, 1.45 to 1.78) and frequent physical distress (aOR = 1.96; 95% CI, 1.80 to 2.14). Similar associations were observed among adults without cancer. CONCLUSION:Sleep aberrations may serve as an important health marker among adults with and without cancer history although findings should be interpreted in the context of a broad, predominantly long-term survivorship population.
The incidence of early-onset gastrointestinal (GI) cancers, typically defined by diagnosis before age 50 years, is rapidly rising in the United States and around the world. Although the underlying drivers of this trend are incompletely understood, emerging evidence suggests that environmental exposures and lifestyle factors play key roles. Patients with early-onset GI cancers face unique challenges over the course of their care. Young patients often experience diagnostic delays, present at more advanced stages, and have more aggressive tumor biology than their older counterparts. Patients with early-onset cancers are also frequently offered more intensive treatment, although with unclear benefit. Beyond these medical differences, early-onset patients may experience increased psychosocial distress compared with older patients, including higher rates of financial toxicity, childcare needs, depression and anxiety, concerns about relationships and sexuality, distress about fertility consequences, and disruption of educational and career trajectories. However, current clinical practice patterns often fail to adequately address the unique needs of early-onset patients. Although several large academic centers have modeled the implementation of specialized multidisciplinary programs to care for patients with early-onset colorectal cancer, broad access to these programs remains limited. Future work must evaluate the scalability of these models to other GI cancer sites across diverse care settings, as well as improve equitable access to timely diagnosis and optimal care for this growing patient population.
PURPOSE:Adherence to operative standards and thorough documentation of surgical technique are critical, particularly in multidisciplinary clinical trials. We sought to evaluate variability in the performance and documentation of oncologically relevant aspects of technical surgery among patients enrolled in Alliance A021501, a phase 2 National Clinical Trials Network randomized clinical trial of neoadjuvant therapy for borderline resectable pancreatic adenocarcinoma. METHODS:We reviewed the primary operative and pathology reports of all enrolled patients who underwent complete pancreatic resection. Operative techniques and pathologic end points with potential to influence recurrence and survival were evaluated. RESULTS:Fifty-one of 126 study participants (40.5%) underwent complete pancreatectomy. The extent of lymphadenectomy was documented in 36 (70.6%) operative reports, and 5 (9.8%) reports outlined the specific lymph node stations removed. Periadventitial dissection of the superior mesenteric artery was described in 25 of 50 (50.0%) operative reports. Immediate histopathologic analysis of the hepatic duct and pancreatic parenchyma margins was documented in 29 of 50 (58.0%) and 32 of 49 (65.3%) reports, respectively, and presence or absence of residual disease following resection was documented in 9 of 51 (17.6%) reports. Specimen orientation was documented in 19 of 51 (37.3%) pathology reports, and 30 of 49 (61.2%) pathology reports stated the distance between the tumor and final SMA margin. CONCLUSION:Even in this rigorously controlled, multicenter, randomized pancreatic cancer clinical trial, performance of key elements of technical surgery was inconsistent, and documentation was incomplete. Standardization of technique and documentation in clinical trials and within clinical practice should be addressed to improve quality assurance and trial interpretability.
PURPOSE:Hematology care delivery is changing rapidly for patients, care teams, and health care institutions. This study simultaneously evaluated utilization data for synchronous/real-time patient appointments, asynchronous/time-delayed patient communications, and provider preferences in a large academic hematology practice to inform sustainable care delivery and workflows in the digital era. METHODS:We conducted a retrospective analysis of aggregated adult hematology appointment and patient communication data at Mayo Clinic (Rochester, MN) from January 2023 to January 2025. Data were stratified by appointment modality, patient characteristics, and electronic health record (EHR) message volumes. Additionally, a voluntary, anonymous survey assessed hematology provider preferences regarding appointment modalities, in-basket burdens, and billing practices. RESULTS:Among 83,713 completed appointments, 80.8% were in-person, 12.9% video, and 6.4% telephone. Patients age 80 years and older and rural cohorts used virtual modalities at rates comparable with younger and metropolitan cohorts. Asynchronous communication volume was considerable, with 155,036 patient-initiated telephone calls generating a digital cascade of 407,578 EHR messages (a 1:2.6 ratio) and 49,798 patient-initiated advice request in-basket messages generating 343,030 additional EHR messages (a 1:6.9 ratio). Providers (n = 53) strongly preferred in-person appointments for new consults (92.5%) and active therapy management (90.6%) but favored virtual appointments for surveillance (52.8%). Although 86.8% of providers reported spending >30 minutes daily on in-basket management, 94.3% reported not billing for this time. CONCLUSION:Telehealth is a substantial component of modern hematology practice, used across all age groups. However, digital cascading and proliferation of asynchronous communications present an invisible and uncaptured workload. Optimizing care delivery could include implementation of a stratified hybrid model, prioritizing in-person appointments for high-acuity needs and virtual appointments for low-acuity needs, alongside standardized workflows to mitigate burdens of the digital era.
PURPOSE:As part of the Alliance of Dedicated Cancer Centers' Improving Goal-Concordant Care (IGCC) initiative, we developed and delivered virtual communication skills training (CST) series to improve the quality of serious illness communication and goal-concordant care (GCC) targeting hematologists, medical oncologists, and advanced practice providers (APPs). METHODS:The CST included two live-virtual workshops: (1) communication frameworks for GCC and difficult conversations and (2) advance care planning (ACP), including documentation and billing. Workshops incorporated didactics, interactive case discussions, role-play exercises, and training in electronic health record documentation and ACP billing. Clinician confidence and feedback were assessed via postworkshop evaluations. Patient-reported experience was assessed using the heard and understood (HAU) scale from Press Ganey surveys. Pre-/post-training changes in top-box HAU scores were analyzed via paired t-tests and mixed-effects modeling. RESULTS:Ninety-three clinicians completed the training evaluation for workshop 1, and 98 completed the evaluation for workshop 2. Over 75% of participants rated content as good or outstanding, with strong gains in self-reported confidence in using ACP tools, Physicians Orders for Life-Sustaining Treatment (POLST) forms, billing codes, and the SPIKES protocol to deliver difficult news. Compared with pretraining scores, physicians demonstrated significant improvement in overall patient-reported HAU scores (79.46 v 83.77, P = .002), particularly for patient perception of being HAU (78.04 v 83.27, P = .012). APPs had higher baseline scores than physicians (90.74 v 78.04, P < .001), with no significant change post-training. CONCLUSION:Our IGCC CST series improved clinician-reported confidence in applying the learned skills and enhanced patient-reported communication quality among physicians, supporting broader implementation of the training program to strengthen serious illness communication in oncology care.
PURPOSE:Approximately 8% of the US population speaks primary languages other than English. Limited English proficiency (LEP) contributes to under-representation of Hispanic patients in oncology clinical trials. Although certified translation services exist, they are time-consuming and costly. Artificial intelligence (AI)-generated translations of informed consent forms (ICFs) could provide low-cost alternatives, but data on accuracy and safety remain limited. We evaluated language equivalence of English-to-Spanish translations for three oncology clinical trial ICFs using two general-purpose AI translation tools (DeepL Pro and ChatGPT-4o) and a medically trained AI translation tool (Med_English2Spanish) compared with certified translations. METHODS:Translational equivalence was assessed using a five-point Likert scale on five domains: Semantic, Idiomatic, Experiential, Conceptual, and Safety. Two native Spanish-speaking bilingual board-certified physicians independently scored each translation. Weighted Cohen's kappa determined inter-rater reliability, and the two-sample t-test compared AI-generated and certified translations. RESULTS:Weighted Cohen's kappa (0.95, 95% CI 0.85 to 0.97) exhibited high inter-rater agreement. Certified translations exhibited the highest equivalence (mean = 4.99, SD = 0.02). ChatGPT-4o similarly demonstrated high equivalence (mean = 4.89, SD = 0.17). DeepL Pro scored well (mean = 4.43, SD = 0.07) but lower than certified translation (P < 0.001). Med_English2Spanish demonstrated the lowest degree of equivalence (mean = 3.32, SD = 0.40) compared with certified translations (P < 0.001). CONCLUSION:Low-cost AI translations of ICFs exhibited variable language equivalence compared with certified translations across several domains. ChatGPT-4o scored nearly equivalent across domains in translating procedural trial information. While AI-generated translations are currently not suitable for clinical deployment without human review, this exploratory study supports further analysis of AI translation tools for reducing language barriers to LEP population enrollment.
PURPOSE Self- and clinician-administered combination therapy is the standard of care for multiple myeloma. Unlike traditional Medicare (TM), Medicare Advantage (MA) plans use utilization management for clinician-administered drugs, which could limit access to these novel regimens. Our objectives were to assess differences in the initiation and type of antimyeloma treatment between MA and TM beneficiaries. METHODS We used the SEER-Medicare–linked database to identify and classify initial antimyeloma treatment into one of the following mutually exclusive categories: self-administered, clinician-administered, or combination of self- and clinician-administered. We used modified Poisson regression models to assess the probability of initiating antimyeloma treatment in the 12 months after diagnosis and, among those treated, the likelihood of starting specific types of treatment (eg, combination v self-administered). RESULTS Among the 15,049 beneficiaries studied, 43.6% were enrolled in MA. Initiation of antimyeloma treatment was similar between MA (74.65%) and TM (73.22%) beneficiaries; however, a larger proportion of TM beneficiaries started combination therapy relative to their MA counterparts (52.45% v 48.64%). Type of Medicare coverage was not associated with antimyeloma treatment initiation (adjusted risk ratio [aRR], 1.02 [95% CI, 1 to 1.04]). Compared with TM beneficiaries, MA beneficiaries had a higher likelihood of starting self- versus clinician-administered treatment (aRR, 1.16 [95% CI, 1.08 to 1.25]), but a lower probability of starting combination therapy versus self-administered treatment (aRR, 0.93 [95% CI, 0.90 to 0.95]). CONCLUSION Antimyeloma treatment initiation did not differ by type of Medicare coverage; however, MA beneficiaries were less likely than TM beneficiaries to initiate combination therapy—the standard of care. Future research is needed to examine the clinical outcomes associated with the type of antimyeloma treatment initiated by beneficiaries.
PURPOSE:Systematic integration of tobacco cessation treatment within cancer centers is needed to improve smoking cessation outcomes among cancer patients and survivors. The current study characterizes baseline rates of tobacco use, use of cessation support, and changes in tobacco use over time among 756 participants diagnosed with cancer and enrolled in 9 ECOG-ACRIN Cancer Research Group trials. MATERIALS AND METHODS:Participants completed surveys at trial enrollment and at 3- and 6-month follow-ups. Descriptive statistics were used to characterize patient characteristics and selected items from the Cancer Patient Tobacco Use Questionnaire (C-TUQ). Generalized estimating equations were used to examine the time point effect on tobacco product use. RESULTS:At baseline, 11% of participants (n = 740) currently smoked cigarettes. Among participants with data available at all time points (n = 443), prevalence of current smoking was stable over time, with 7.2% of participants (n = 32) reporting current smoking at baseline, 7.0% (n = 31) at the 3-month follow-up assessment, and 6.8% (n = 30) at the 6-month follow-up assessment. Most participants (n = 77/104) who smoked cigarettes within the year prior to their cancer diagnosis continued smoking after their diagnosis, and during (n = 44/72) and following completion (n = 30/46) of their treatment. Sixty-two percent of participants (n = 81) who were currently smoking at baseline reported using smoking cessation medication and 32.1% reported use of nonpharmacologic smoking cessation support since their cancer diagnosis. In longitudinal analyses, the odds of using cigarettes since their cancer diagnosis, 3-month follow-up, and 6-month follow-up was higher than the odds of using cigarettes for the past 30 days at baseline (odds ratio [OR] = 1.97, OR = 1.62, and OR = 1.50, respectively; all ps < .01). CONCLUSION:Smoking persists over time among patients with cancer enrolled in therapeutic cancer trials. Findings highlight the importance of increasing access to integrated and longitudinal smoking cessation support.
