Journal of the National Cancer Institute. Monographs最新文献

{"title":"Perspectives on sexual orientation and gender identity data collection from healthcare system staff and leadership: case study in an academic hospital setting.","authors":"Alice Guan, Christine Duffy, Zinnia Loya, Michelle Wadhwa, Scarlett Lin Gomez, Salma Shariff-Marco","doi":"10.1093/jncimonographs/lgaf014","DOIUrl":"10.1093/jncimonographs/lgaf014","url":null,"abstract":"<p><p>Collecting sexual orientation and gender identity (SOGI) data in healthcare settings is essential for addressing the unique health needs and cancer burden of this population. We conducted a qualitative study to assess institutional leadership and staff perspectives on collecting SOGI data, aiming to improve these processes within our academic medical center. In key informant interviews with 17 staff and leaders, we asked about current SOGI data collection practices and facilitators/barriers for implementing systematic data collection. We sought to understand staff experiences with SOGI data collection, comfort and willingness to collect these data, and challenges in broad implementation of SOGI data collection. Findings indicate need for: training on SOGI data collection to increase staff confidence in engaging with patients; clear workflows for when, how, and by whom SOGI data should be collected; and implementation of flexible approaches to data collection, while balancing patient privacy.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"111-116"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collecting sexual orientation and gender identity data in cancer centers.","authors":"Kellan Baker","doi":"10.1093/jncimonographs/lgaf037","DOIUrl":"10.1093/jncimonographs/lgaf037","url":null,"abstract":"","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"73-75"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing a stakeholder-informed approach for standardized collection of sexual orientation and gender identity data: lessons learned at a matrix comprehensive cancer center.","authors":"Susan L Parker, Montserrat Ayala-Ramirez, Jane R Montealegre, Michael E Scheurer","doi":"10.1093/jncimonographs/lgaf013","DOIUrl":"10.1093/jncimonographs/lgaf013","url":null,"abstract":"<p><p>This brief report describes takeaways from the implementation of sexual orientation and gender identity (SOGI) data collection within a matrix comprehensive cancer center. Implementation of standardized and parsimonious SOGI data collection practices is a strategy recommended to improve our understanding of the cancer experiences among sexual and gender minority (SGM) populations. However, interventions are rarely sustained in routine practice without an organized program to support their implementation. We used a stakeholder-engaged approach to integrate a SOGI questionnaire in the electronic health record (EHR) at Dan L Duncan Comprehensive Cancer Center (DLDCCC)-affiliated adult oncology clinics and evaluate its feasibility, acceptability, and utilization among providers and staff. In Phase 1, we convened a Stakeholder Advisory Board (SAB) for this project comprising leadership, providers, and members of the LGBTQ+ community. Through focus groups held over a 12-month period, the SAB defined barriers and facilitators to SOGI data collection and determined strategies to support the sustained implementation of SOGI data collection in oncology clinics. In Phase 2, we assessed the acceptability and feasibility of SOGI data collection among providers and staff. Semistructured interviews showed that key stakeholders perceived SOGI data collection as highly acceptable and feasible. These stakeholders perceived that SOGI data collection may improve clinical decision-making and help provide better patient-centered care to sexual and gender minorities. Barriers at multiple ecological levels hinder routine SOGI data collection. Bundling SOGI data collection implementation with other institutional initiatives was a successful strategy for our partner institution. Implementation strategies focused on provider and staff education. SOGI data collection is highly acceptable among stakeholders in DLDCCC-affiliated adult oncology clinics.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"134-138"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient perspectives on safety and privacy in sexual orientation and gender identity data collection.","authors":"Jessica B Lewis, Ash Alpert, Deron Galusha, Alie Brussel Faria, Allister Hirschman, Hill L Wolfe, Lou Hart, Marcella Nunez-Smith, Karen H Wang","doi":"10.1093/jncimonographs/lgaf015","DOIUrl":"10.1093/jncimonographs/lgaf015","url":null,"abstract":"<p><strong>Background: </strong>There is insufficient epidemiologic data to serve sexual and gender minority communities. However, disclosing sexual orientation and gender identity in health care presents risks to patients.</p><p><strong>Methods: </strong>We collected surveys from 174 cancer hospital patients to understand their perspectives on safety associated with sexual orientation and gender identity data collection.</p><p><strong>Results: </strong>Overall, 18.4% of participants identified as sexual or gender minorities. Sexual and gender minority participants were more likely to report experiencing unequal treatment in health care than participants who did not identify as a sexual or gender minority. Most patients felt safe or comfortable answering sexual orientation and gender identity questions and having health-care professionals within their health system view their data. Fewer wanted data available to front-desk staff or shared to other health systems. Few thought sexual orientation and gender identity was important to health care. Most believed their data would be kept safe and private; patient concerns included stigma, privacy, and data vulnerability.</p><p><strong>Conclusions: </strong>Better policy protections and data segmentation are needed to achieve patient safety and health-care quality related to sexual orientation and gender identity data collection.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"170-176"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268159/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeted intervention and monitoring of sex assigned at birth, sexual orientation, and gender identity data scale-up: the intersection of research, policy, and patient care.","authors":"Paige N Hackenberger, Kevin Hascher, Reese Owens, Andrew Witt, Cynthia Barnard, Deja R Glover, Paul Nelson, Jenni Holtz, Bess Lenz, Sumanas W Jordan, Lauren B Beach","doi":"10.1093/jncimonographs/lgaf005","DOIUrl":"10.1093/jncimonographs/lgaf005","url":null,"abstract":"<p><strong>Background: </strong>To achieve a paradigm shift in the rigor of sexual and gender minority cancer studies, health systems must integrate sex assigned at birth, sexual orientation, and gender identity (SSOGI) measures into electronic medical records (EMRs) and scale up SSOGI data collection in oncology settings. The SSOGI Collect project sought to identify barriers and facilitators for SSOGI data collection and design a tailored intervention to inform and encourage oncology staff to increase collection in a culturally sensitive manner.</p><p><strong>Methods: </strong>We employed mixed methods, including qualitative interviews with oncology staff, live training sessions on SSOGI data collection, and monitoring of SSOGI documentation rates in the EMR.</p><p><strong>Results: </strong>Fifteen semistructured interviews with oncology staff were conducted. Forty live training sessions were delivered to health system personnel on SSOGI data collection. After trainings, SSOGI documentation rates increased in both targeted oncology clinics and across the health system as a whole.</p><p><strong>Conclusions: </strong>The SSOGI Collect project demonstrated that live training sessions are an effective strategy for improving SSOGI data collection in oncology settings. This initiative aligned with an unexpected, broader health system effort to enhance SSOGI data collection in response to new state legislation. This study highlights the importance of tailored interventions for integrating SSOGI data into EMRs, which led to improved data completeness and documentation across oncology clinics and the wider health system.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"161-169"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation factors for sexual orientation and gender identity patient data collection in a comprehensive cancer center: findings from a center-wide readiness assessment survey for the ASK Sexual Orientation and Gender Identity study.","authors":"Miria Kano, Marisa Sklar, Ryan O'Connell, Dolores Guest, Amy Farnbach Pearson, Andrew L Sussman, Bernard Tawfik, Zoneddy Dayao, Cameron Crandall, Cathleen Willging","doi":"10.1093/jncimonographs/lgaf009","DOIUrl":"10.1093/jncimonographs/lgaf009","url":null,"abstract":"<p><p>Between September 2022 and August 2024, a mixed-method study was conducted at the University of New Mexico Comprehensive Cancer Center to enhance sexual orientation and gender identity data collection to facilitate meaningful use of sexual orientation and gender identity data in clinical care for sexual and gender minority patients. This report presents findings from a center-wide readiness assessment survey to identify and analyze the complex challenges affecting sexual orientation and gender identity data collection implementation. Over a 1.5-month period, a REDCap online survey was distributed to assess organizational and individual readiness to implement and expand on the collection of sexual orientation and gender identity data at the cancer center. The survey consisted of 4 widely used readiness measures: Organizational Readiness for Implementing Change; Implementation Leadership Scale; Implementation Climate Scale; and an adapted version of the Lesbian, Gay, Bisexual, Transgender, Queer (or Questioning), Intersex Health Knowledge, Attitudes and Practice Scale. Findings specific to perceived gaps in leadership support and resource provision informed multilevel strategies to improve sexual orientation and gender identity data collection and use.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 69","pages":"117-120"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12268150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144651392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design considerations and challenges in the CHinA National CancEr Screening (CHANCES) trial and Tomosynthesis Mammographic Imaging Screening Trial (TMIST).","authors":"Ping Hu, Jon A Steingrimsson, Elodia Cole, Jean Cormack, Barbara K Dunn, Constantine Gatsonis, Cecilia Lee, Ni Li, Etta D Pisano, Jie He, Barnett S Kramer","doi":"10.1093/jncimonographs/lgae049","DOIUrl":"10.1093/jncimonographs/lgae049","url":null,"abstract":"<p><p>This paper explores the design considerations and hurdles encountered by the CHinA National CancEr Screening (CHANCES) Trial and the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), both aimed at advancing cancer screening research. Before population-based cancer screening programs are launched, it is important to have confidence that the potential benefits of the screening process and resulting interventions outweigh harms, an ethical imperative because the people actively invited into the programs are relatively healthy. Large randomized screening trials provide the strongest, direct evidence regarding the balance of benefits and harms. The implementation of cancer screening programs involves a series of steps, with outcomes influenced by factors such as the prevalence of the disease, availability of effective treatment within the health-care system, and acceptance by the target population-all of which may vary considerably from country to country. This paper examines how these factors shaped the design and statistical approach of the CHANCES Trial for lung and colorectal cancers and the TMIST trial for breast cancer. We discuss the rationale, objectives, endpoint definitions, trial designs, and sample size considerations, highlighting both the challenges and opportunities presented in different settings. Ultimately, the goal is to foster collaboration and develop screening strategies that are scientifically robust and practically effective for diverse populations worldwide.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 68","pages":"42-48"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143484895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the use of external controls in clinical trials.","authors":"Michelle M Nuño, Stephanie L Pugh, Lingyun Ji, Jin Piao, James J Dignam, Jon A Steingrimsson","doi":"10.1093/jncimonographs/lgae046","DOIUrl":"10.1093/jncimonographs/lgae046","url":null,"abstract":"<p><p>Externally controlled trials have commonly been used when conducting a randomized controlled trial (RCT) is not feasible or ethical. By allowing the study of new treatments, use of external controls can lead to accelerated advances in the management of rare diseases. The use of external controls, however, introduces new challenges due to potential differences between the population the external controls are enrolled from and the population the patients on the new trial are enrolled from. Some differences include, but are not limited to, differences in how patients are diagnosed and treated, differences in the case mix of the underlying populations, differences in the ability to measure outcomes, and differences in data collection. We discuss the potential benefits and challenges of externally controlled trials, as well as strategies to mitigate bias, including the estimand and target-trial emulation framework. We also provide a brief overview of statistical methodology commonly used in these settings. We note that although the strategies presented may help mitigate some of these challenges, they cannot replace an RCT framework, and investigators should be aware of the potential limitations of externally controlled trials.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 68","pages":"30-34"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143484947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges to and considerations of designing cancer prevention trials.","authors":"Danielle M Enserro, Heather J Gunn, Mohamed I Elsaid, Fenghai Duan, Stephanie L Pugh","doi":"10.1093/jncimonographs/lgae044","DOIUrl":"10.1093/jncimonographs/lgae044","url":null,"abstract":"<p><p>Prevention trials in oncology are some of the most important cancer clinical trials that can be designed, implemented, analyzed, and interpreted. They are pivotal in the goal of stopping the development of cancer before it starts. Prevention trials are unique in that they not only have some of the same requirements and challenges as treatment trials but also have challenges that may make their design more complex. This paper aims to discuss some types of prevention trials and highlight their most common design challenges, including large sample size requirements, slow accrual rates with long accrual duration, extended follow-up periods with trial adherence issues and missing data, endpoints that require extended follow-up or have a high level of confounding, and problems with optimizing study design. This article provides real study examples and suggestions for designing prevention clinical trials while mitigating the known issues they face.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 68","pages":"49-55"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143484885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The importance of patient-centered research in oncology clinical trials: motivation for the Monograph series.","authors":"Stephanie L Pugh, Cecilia Lee, Barbara K Dunn, James J Dignam","doi":"10.1093/jncimonographs/lgae052","DOIUrl":"10.1093/jncimonographs/lgae052","url":null,"abstract":"","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2025 68","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143484960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}