bluuebunny/crossref_metadata_2025_split huggingface dataset:
Perceptions of non-disclosure of results in clinical trial designs for multicancer detection tests.
Authors: Samimi Goli , Temkin Sarah M. , Weil Carol J. , Han Paul KJ , LeeVan Elyse , Rubinstein Wendy S. , Swigart Tessa , Caban Sarah , Dent Katherine , Minasian Lori M. 
Published: June 2024

10546 Background: Multi-cancer detection tests (MCDs) are blood-based tests designed to detect multiple cancers. The National Cancer Institute (NCI) is planning a pilot study to ascertain the feasibility of recruitment and the necessary infrastructure, clinical workflow, and diagnostic pathways for conducting a large clinical trial to assess whether cancer screening using MCDs reduces cancer mortality. In preparation for these activities, the NCI conducted a qualitative focus group study with primary care physicians (PCPs) and laypersons to explore the acceptability of alternative MCD trial designs, including the disclosure vs. non-disclosure of MCD test results to study participants. Methods: Focus groups were conducted with convenience samples of PCPs (6 groups, N=45) and laypersons (4 groups, N=88) by a consumer research firm. Interviews used both open-ended questions and specific prompts to explore participants’ perceptions of alternative clinical trial designs. Interviews were audio-recorded and transcribed, and qualitative thematic analysis of interview transcripts was conducted to identify emergent themes. Results: In general, PCPs and laypersons reported a willingness to refer or participate in an MCD trial regardless of design, with the understanding that clear and transparent information would be provided in the consent process. However, both groups expressed concern with a trial design in which patients in the control arm would not receive their MCD test results—a design that would allow a marked reduction in sample size and time necessary to assess a mortality endpoint. PCPs noted that although this design might be ethically acceptable due to current clinical equipoise about MCD testing, they expressed concern about mistrust among patients and medical-legal liability. Laypersons had difficulty understanding the rationale for non-disclosure of MCD test results during a trial, and concerns about the ethics of non-disclosure. Some participants felt more comfortable if return of value with other information was included as part of routine study procedures. Participants were more comfortable with an alternative design involving delayed testing of stored blood samples from the control group after trial completion. PCPs also expressed concern about increased workloads if their patients enrolled. Conclusions: PCPs and laypersons had generally positive reactions to a trial to investigate diagnostic performance, pathways, and outcomes of MCDs. Concerns about study designs involving non-disclosure of results might be managed through return of value strategies, careful education, and clear communication of the benefits and risks of MCDs.
Increasing cancer-related mortality and demographic disparities in young adults in the United States between 1999 and 2020.
Authors: Didier Alexander James , Fahoury Alan , Nandwani Swamroop , Campbell Andrew , Batten Macelyn , Sutton Jeffrey M. 
Published: June 2024

10569 Background: The global rise in cancer incidence in the young adult population (≤ 45 years), particularly in obesity-related cancers, is of growing concern. As the demographic afflicted by cancer expands beyond traditional boundaries, a nuanced understanding of the unique characteristics and challenges specific to young adults is imperative for developing interventions that address their distinct needs. In this study, we characterize cancer mortality rates in the young adult population to assess for emerging trends and cancer burden in the United States. Methods: The Centers for Disease Control database was queried for all underlying causes of death due to cancer (ICD 10 codes C00-C97) between 1999 and 2020. Malignancies that primarily affect the elderly, such as prostate and multiple myeloma, were excluded. Age-adjusted mortality (AAMR) rates per 100,000 people were extracted for adult patients between 25 and 44 years of age. AAMR was assessed by demographic and clinical variables, including race, geographic density, sex, and primary site. Joinpoint trend analysis was used to identify the presence of statistically significant temporal trends. Average annual percent change (AAPC) was considered statistically significant if p < 0.05. Results: Between 1999 and 2020, 366,478 cancer-related deaths occurred in young adults in the United States. The overall AAMR was 20.7, decreasing from 24.8 in 1999 to 17.5 in 2020 at a rate of -1.6% annually (p<0.05). However, increasing mortality was seen in a number of primary sites, including uterine cancer with an increase of 2.6% annually (p<0.05) and colorectal cancer with an increase of 0.8% annually (p<0.05). Overall AAMR was highest for non-Hispanic Black individuals at 28.3, 29% higher than the next highest group (non-Hispanic White) at 21.2 and almost double that of non-Hispanic Asians at 14.7. Individuals residing in rural populations experienced the highest AAMRs at 24.3 and the slowest rates of decrease at -1.6% annually (p<0.05), compared with urban individuals whose AAMR was 19.8 with a decrease of -1.9% annually (p<0.05). Primary sites with the highest AAMRs included breast (3.1), lung (2.1), and colorectal (1.8) cancers. Conclusions: The current study sheds light on the evolving landscape of cancer mortality among young adults in the United States. The overall decrease in age-adjusted mortality rates is promising, reflecting advancements in cancer care and prevention strategies. However, the alarming increase in mortality rates for specific cancer types, such as uterine and colorectal cancers, underscores the need for targeted interventions and heightened awareness, especially in at-risk populations. The identified racial and geographic disparities further emphasize the importance of implementing tailored approaches to address the unique challenges faced by diverse populations.
Statewide burden of cancer attributable to alcohol use in the United States in the last three decades, projections of deaths to 2040: A benchmarking study.
Authors: Potluri Geethika , Obulareddy Sri Usha Jeevani , Koyani Himanshu Bharatkumar , Gadhiya Dhruvkumar , Markandu Keethanshan , Maddineni Kavya , Adedara Victor O , Parisapogu Anusha , Desai Hardik Dineshbhai , Patel Rushin , Zakia Ummul Barakat , Bramwell Colleen 
Published: June 2024

10575 Background: Cancer stands as the 2nd leading cause of deaths and disability in the United States (US), and among the numerous contributing factors, modifiable risk factors play a significant role in exacerbating this burden. Within the spectrum of cancers, alcohol consumption ranks as the second leading attributable cause of death, as per the Global Burden of Disease Cancer Attributable Risk Factor Study. Methods: Employing the GBD protocol, we conducted an estimation of deaths, disability-adjusted life years (DALYs) attributable to cancer caused by alcohol consumption in the US. This comprehensive analysis was stratified by age, gender, year, and geographical location throughout the US, from 1990 to 2019. To project future trends, we utilized time-series regression techniques to forecast deaths until the year 2040. Results: The total number of cancer-related deaths in the US surged from 19,898 (95%UI: 17,791-22,149) in 1990 to 34,455 (30,542-38,388) in 2019. Concurrently, DALYs increased from 532,533 (480,249-586,646) in 1990 to 854,351 (764,549-949,378) in 2019, and YLLs rose from 501,639 (452,446- 554,400) in 1990 to 802,493 (717,123-891,789) in 2019. The highest annual percentage change (APC) in ASR for mortality was observed in West Virginia, with a 32% increase, followed by Tennessee at 27%. Conversely, the District of Columbia witnessed the most significant decrease, with a 30% reduction from 1990 to 2019. In terms of DALYs rates, the highest increases were observed in West Virginia (27%) and Oklahoma (21%). Males bore a greater overall burden compared to females, with an APC in deaths of 97% vs 40% and an APC in DALYs of 87% vs 26%. The highest number of deaths occurred in the 60-64 age group, with 5,228 cases in 2019, while DALYs reached 154,034 in the same year. Projections indicate that the total number of deaths is expected to increase by 49,230 by the year 2040. Conclusions: In 2019, cancer-related deaths attributed to alcohol use represented 4.42% of all cancer mortality cases. From both a public health and clinician perspective, the study's results highlight the urgent need for comprehensive strategies to address the growing burden of cancer associated with alcohol use. Efforts should focus on prevention, early intervention, and support for individuals struggling with alcohol-related cancer risks. [Table: see text]
Improving feasibility and timeliness of hereditary cancer risk assessment with a brief patient-administered digital tool and rapidly available telehealth genetic counseling.
Authors: Daley Ashley , He Wenjun , Iverson Gabrielle , Petersen Jenna , Hila Andi , Johnson Kiley , Caleshu Colleen 
Published: June 2024

10614 Background: Multiple guidelines recommend hereditary cancer risk assessment for all adults, yet it rarely is performed. This is largely due to the time-consuming nature of such assessments and difficulty with access to genetic counseling for those at high risk. We designed a care model to address these issues that is suitable for both oncology and non-oncology settings. It includes a brief patient-administered and clinically validated digital hereditary cancer risk assessment tool, followed by immediate online self-scheduling features for telehealth genetic counseling, with appointments available within 48 hours. The digital tool uses a guideline-based algorithm to assess whether genetic testing for hereditary cancer risk is indicated. Here we aim to evaluate the effectiveness and timeliness of this model. Methods: We conducted a retrospective chart review of consecutive patients that engaged with this model from May 2021 to August 2023 at 32 obstetrics and gynecology clinics. We also used nationwide data from the National Society of Genetic Counselor's (NSGC) Professional Status Survey. To assess timeliness of genetic counseling appointments in this care model, we compared the time from scheduling the appointment to the start of the appointment to wait times at health systems for comparable non-urgent cancer genetic counseling appointments, from the NSGC data. Effectiveness was assessed via rates of completion of the tool and scheduling of genetic counseling. Results: 2538 patients (98% female, mean age 37 years, 3.9% with a personal history of cancer) initiated the care model and 95% (2415/2538) completed the risk assessment tool. A quarter (26% (628/2415)) met criteria for germline genetic testing. The median time to complete the tool was 2.7 minutes (IQR 2.9). At the end of the tool, patients could click a button to schedule an appointment with a genetic counselor to discuss hereditary cancer risk and genetic testing. 44% (274/628) booked an appointment. The median time from scheduling to genetic counseling appointment was 2.8 days (IQR 4.9 days), which is shorter than the median wait time for comparable genetic counseling appointments at health systems in the nationwide NSGC dataset (21 days (IQR 53 days); p<< 0.01). Conclusions: The tool completion rate, rate of patients meeting criteria, and uptake of genetic counseling indicate the model is effective. Timeliness was improved by this model, with the digital tool assessing risk in ~3 minutes, compared to previous reports of ~30 minutes for manual hereditary cancer risk assessment. In addition, the timeliness of genetic counseling appointments was markedly better than the current standard of care. These findings suggest that this care model can support physicians in providing timely guideline-recommended hereditary cancer risk assessment to their patients.
Contribution of mammography to breast cancer detection among pathogenic germline BRCA carriers by age and mutated gene.
Authors: Goldvaser Hadar , Bernstein-Molho Rinat , Michaelson-Cohen Rachel , Moss Lior , Gekhtman David , Sklair-Levy Miri , Rabinovitch Rachel , Tomer Ariela , Miller Yahelli , Moore Pnina , Levy-Lahad Ephrat , Lieberman Sari 
Published: June 2024

10615 Background: Healthy carriers of pathogenic germline BRCA 1/2 (gBRCA) may choose between risk reducing mastectomy and intensive screening surveillance. Current international guidelines recommend both annual breast MRI and annual mammography. The aim of this study was to investigate the added contribution of annual mammography in gBRCA carriers to the annual breast MRI. Methods: A retrospective study from 2 large centers comprising gBRCA carriers who were diagnosed with breast cancer between 2000-2022 and were aware of their gBRCA status prior breast cancer diagnosis. Collected data included age at diagnosis, mutated gene and mode of breast cancer diagnosis (MRI, mammography, ultrasound [US], or other means [including clinical or incidental findings]). Data on pregnancy and breastfeeding at the time of breast cancer diagnosis were also collected. Differences in the mode of diagnosis were analyzed by age (≤40y vs. >40y) and mutated gene (BRCA1 vs. BRCA2). Results: The cohort included 200 gBRCA carries: 134 (67%) BRCA1, 62 (31%) BRCA2 and 4 (2%) with both BRCA1 and BRCA2 mutations. The median age at the time of breast cancer diagnosis was 41 (24-88). Most cancers (68%) were diagnosed by MRI, followed by mammography (14.5%), US (7%) and other means (10.5%). While MRI was the most common diagnosis modality in both age groups, the distribution of mode of diagnosis was significantly different in younger women (≤40y) where breast cancer detection was more commonly by US or following clinical findings, compared to older women, p< 0.001 (see Table). Five women were pregnant and 9 women were breastfeeding at the time of breast cancer diagnosis, all age 40 or younger. Four (80%) of pregnant carriers and 5 (55.6%) of breastfeeding carriers were diagnosed by US. There was no difference in mode of diagnosis between BRCA1 to BRCA2 carriers, p=0.974. There were only 16 women under age 30 that were diagnosed with breast cancer, 2 (12.5%) of whom were diagnosed with mammography. Conclusions: MRI is the most common modality for breast cancer diagnosis in gBRCA carriers who were aware if there gBRCA prior breast cancer diagnosis. Annual mammography also has a meaningful role in this population. We did not identify a subgroup in which it could be omitted. The increased utility of US among younger women is attributed to reduced utilization of MRI/mammography during pregnancy and breastfeeding. This finding strengthens the role of US screening in gBRCA carriers who are not eligible for other methods of imaging. [Table: see text]
Beyond the binary: A transformative implementation science initiative to improve LGBTQ+ cancer care.
Authors: Maingi Shail , Schabath Matthew B. , Dewald Ilona , Storey Janet , Dooyema Samuel , Carter Jeffrey D. , Heggen Cherilyn , McKinnon Kelly 
Published: June 2024

11010 Background: Patient, provider, and system-level barriers contribute to significant disparities in care of LGBTQ+ persons, including delays in screening and diagnosis, and poorer outcomes. This implementation science initiative was designed to identify and address root causes of disparities in care for LGBTQ+ patients (pts) and drive sustainable change to improve health equity in LGBTQ+ cancer care. Methods: In 2023, a steering committee of 3 expert oncologists and 5 LGBTQ+ cancer pts convened to develop survey instruments and a point-of-care LGBTQ+ Cancer Care Toolkit. Next, LGBTQ+ pts with cancer (N = 817) and oncology providers (OPs) from 2 academic and 5 community-based practices (N = 115) completed surveys to reveal alignments and discordances in beliefs, perceptions, and practices regarding cancer care. OPs participated in audit-feedback (AF) sessions to critically assess system-specific practice gaps, prioritize areas for improvement, and develop action plans for improving LGBTQ+ cancer care. Results: Provider-reported top challenges in care included: unsure how sexual orientation/gender identity (SOGI) affect treatment considerations (35%), unsure how to discuss SOGI (30%), and systemic barriers that limit inclusion (29%). While most providers (84%) were at least moderately comfortable treating LGBTQ+ pts, these data suggest they overestimated the level of comfort of their pts. For example, only 24% of pts reported feeling safe disclosing their LGBTQ+ identity, while 65% of providers thought pts felt safe. Additionally, while most providers (73%) thought it was important to know a pt’s gender identity, only 46% thought it was important to know sexual orientation, and only 3% of providers reported routinely discussing SOGI with new pts. Patients and providers were not concordant in several other key areas, including the experience of pts’ partners, measures of inclusivity, and supportive care services offered, such as fertility preservation. Survey data also revealed systemic barriers to equitable care, such as EMR documentation of SOGI. In AF sessions, teams reviewed survey outcomes, and developed action plans for improvement, including integrating the toolkit, updating EMR documentation, developing LGBTQ+ education, and adopting measures of inclusivity. Notably, following the intervention, there were considerable gains in provider confidence and knowledge, and ~70% of providers committed to discussing SOGI with their pts at first introduction. Conclusions: Through this QI initiative, teams identified patient-, provider-, and systemic-level barriers that affect LGBTQ+ cancer care in their own practices and implemented action plans to address key challenges. The sustainable changes implemented in this QI initiative represent key opportunities for improvement that can be implemented in clinics across the country to improve equitable LGBTQ+ cancer care.
Improving delivery of smoking cessation assistance for patients with cancer: Results of the Beyond ASK quality improvement.
Authors: Mullett Timothy W. , Burris Jessica L , Reilly Eileen M , Shelton Rachel C , Warren Graham W. , Ostroff Jamie S. 
Published: June 2024

11011 Background: Smoking by cancer patients and survivors causes adverse health outcomes, and quitting smoking after a cancer diagnosis can improve survival. However, assistance with smoking cessation is not regularly provided to cancer patients. Reported are results of the national 2023 Beyond ASK quality improvement initiative to increase and sustain delivery of smoking cessation assistance across participating sites. Methods: In 2023, American College of Surgeons Commission on Cancer (CoC) accredited sites were invited to participate in the Beyond ASK quality improvement initiative to increase evidence-based smoking cessation assistance delivery to cancer patients who report current smoking. Participating sites were required to monitor and periodically report on provider performance (e.g., assist rate = number of patients assisted with smoking cessation / number of patients who smoke), resource utilization, barriers, and facilitators. Educational resources, webinars, toolkits, and online data collection were facilitated by CoC. Results: Among 306 participating programs who completed the Beyond ASK initiative (94% of baseline programs), high rates of asking patients about and documenting smoking status were maintained at 88-92% from the baseline to final survey. During the 12-month project period, overall rates of assisting with smoking cessation increased from 53% to 67%. Referral to state quitlines increased from 31% to 49%, and referral to ‘in house’ smoking cessation programs increased from 15% to 28%. Rates of providing brief in office counseling more than tripled from 20% at baseline to 66% at final. The most frequently reported components that contributed to programs’ success were educational webinars (30.6%), structured data collection (28.2%), and smoking cessation toolkit (21.2%). The leading logistical barriers were extracting clinical data from the EHR and making changes to the clinical workflow, reported by 36.5% and 28.2% of respondents, respectively. Overall, 95.3% of respondents “agreed” or “strongly agreed” that identifying patients who smoke and assisting patients with cessation was sustainable. Conclusions: Increasing smoking cessation assistance through a national accreditation organization is feasible with substantial improvements in assisting patients. Results support delivery of smoking cessation as an achievable national quality component of cancer care.
The toxicity swimmer plot: A novel approach for evaluating patient-level toxicity following immune checkpoint inhibitor (ICI) therapy on the Checkmate 214 trial.
Authors: Viray Hollis , Huang Hui , Mantia Charlene , Jegede Opeyemi , Atkins Michael B. , McDermott David F. , Regan Meredith M. 
Published: June 2024

11014 Background: Treatment with ICIs creates the possibility of prolonged disease control or remission but also creates the possibility of prolonged toxicity even after treatment is discontinued. Treatment-free survival (TFS) with and without toxicity has previously been described as an integral piece of a partitioned survival analysis in advanced renal cell carcinoma (aRCC). Prior analyses have reported further partition of TFS as mean duration of TFS with and without treatment-related adverse events (TRAEs), but this metric fails to provide more granular information regarding individual patients experiencing toxicity during TFS. We present a novel extended swimmer plot that characterizes patient-level toxicity data within TFS using the example of the Checkmate 214 trial to complement analyses of the population average experience. Methods: Data were analyzed from the Checkmate 214 trial which randomized 1096 patients with aRCC to receive either first-line (1L) nivolumab plus ipilimumab (n = 550) or sunitinib (n = 546). The minimum follow-up from protocol therapy initiation was 42 months. Patients’ overall survival was partitioned into 3 survival states: time on 1L protocol therapy, TFS, and survival after subsequent therapy initiation. With a re-defined time origin relative to cessation of 1L protocol therapy, we generated swimmer plots highlighting the TFS period and documenting each patient’s experience with and without grade 2+ and grade 3+ TRAEs during TFS. The swimmer plot was sorted by duration of TFS and duration of TFS with grade 2+ TRAEs in order to illustrate patterns of individuals’ experiences. Results: The 42-month mean TFS was 7.8 months (with grade 2+ TRAEs: 3.2 months) for patients treated with nivolumab plus ipilimumab and 3.3 months (1.6 months) for patients treated with sunitinib. In the respective treatment groups, TFS with grade 2+ TRAEs was experienced by 32% and 25% of patients and comprised of 13% and 9% of patients for whom it was the entire TFS period. These percentages were consistent regardless of TFS duration. TFS with grade 3+ TRAEs was experienced by 15% and 3% of patients, respectively. For most patients having TFS with TRAEs, the TRAEs persisted from the protocol therapy period, but 7% and 1% of patients in the respective treatment groups had new-onset grade 3+ TRAE during TFS. A swimmer plot will be presented as a visual presentation of this study’s results. Conclusions: We describe a novel extension of swimmer plots for presenting patient-level information and illustrating patterns in toxicity duration relative to TFS by incorporating individual toxicity data into a swimmer plot of partitioned survival. This approach allows for a more comprehensive understanding of toxicity trends and risk of prolonged toxicity after treatment is discontinued.