Hackenberger PN, Hascher K, Owens R
… +8 more, Witt A, Barnard C, Glover DR, Nelson P, Holtz J, Lenz B, Jordan SW, Beach LB
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671543
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BACKGROUND: 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 electr...BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Kano M, Sklar M, O'Connell R
… +7 more, Guest D, Farnbach Pearson A, Sussman AL, Tawfik B, Dayao Z, Crandall C, Willging C
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671541
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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 meani...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.
Arthur EK, Fuller J, Durusan S
… +6 more, Gill J, Niles K, Gault C, Oliveri JM, Paskett E, Oppong BA
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671540
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BACKGROUND: Though sexual and gender minority people experience multiple cancer disparities, they remain largely invisible in oncology clinical care. Despite repeated calls by national medical and oncology organizations...BACKGROUND: Though sexual and gender minority people experience multiple cancer disparities, they remain largely invisible in oncology clinical care. Despite repeated calls by national medical and oncology organizations to address the lack of sexual orientation and gender identity data, there remains a dearth of information to guide research, clinical care, and creation of national priorities to address important health inequities. We aimed to develop effective strategies to collect sexual orientation and gender identity data within our Midwestern Comprehensive Cancer Center based on barriers and facilitators identified by community members, staff, and clinicians. METHODS: We conducted 5 focus groups of sexual and gender minority and cisgender, heterosexual community members (n = 24). We interviewed clinicians and registration staff across 3 ambulatory cancer clinics (n = 27). Rapid qualitative analysis was used to identify themes from focus groups and interviews. RESULTS: Focus group participants' average age was 37 years with a majority identifying as White (79%, n = 19) and non-Hispanic (92%, n = 22); most participants were women (58%, n = 14) and queer (58%, n = 14). Staff and clinicians' average age was 40 years; most identified as White (82%, n = 22), women (82%, n = 22), and straight (82%, n = 22). Qualitative themes to guide sexual orientation and gender identity data collection included comfort and trust, support services, physical space, training, data collection procedures, data access and privacy, and influence on care. CONCLUSIONS: To encourage patient disclosure, a supportive environment where privacy is upheld and health-care staff are trained to competently interact with lesbian, gay, bisexual, transgender, queer, plus patients is needed. We also share our process of sexual orientation and gender identity data collection implementation at our cancer hospital.
More than 13 million adults in the United States identify as a sexual or gender minority (SGM). This study aimed to describe the barriers and facilitators to SOGI data collection in health-care settings, looking to under...More than 13 million adults in the United States identify as a sexual or gender minority (SGM). This study aimed to describe the barriers and facilitators to SOGI data collection in health-care settings, looking to understand current and past practices with a goal of improving future data collection. With the aid of community-based organizations (CBOs) focused either on cancer or LGBTQ+ issues, 31 individuals were recruited to participate in 4 focus groups. Focus groups were analyzed using thematic analysis, and 5 themes were identified: barriers to SOGI data collection; facilitators to SOGI data collection; discrimination; disclosing SOGI status; shifting landscape of SOGI status and data collection; and practical experiences of SOGI data collection. More than half of the participants identified as Black/African American, and the majority of focus groups participants were sexual or gender minorities. Our study identified gaps in current SOGI data collection practices, experiences of harm in disclosure, and areas for growth and improvement in the overall health experiences for SGM individuals.
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671538
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BACKGROUND: Patient navigators have a range of training, lived experience, and empathy to draw on when working with patients facing breast cancer diagnoses. We examined the knowledge and impact of sexual orientation and...BACKGROUND: Patient navigators have a range of training, lived experience, and empathy to draw on when working with patients facing breast cancer diagnoses. We examined the knowledge and impact of sexual orientation and gender identity (SOGI) data training for patient navigators who work with individuals with a diagnosis of breast cancer. METHODS: We offered a 2-hour SOGI data training to patient navigators working with individuals with known breast cancer diagnoses. This training was preceded by a pretest to gauge work experience, and initial knowledge of SOGI issues and comfort with LGBTQ+ populations. Following the training, we conducted one-on-one qualitative interviews of open-ended questions with each participant in lieu of a posttest. RESULTS: Five patient navigators participated in the training. The participants work experience in medical clinics ranged from 2 to 30 years (mean = 15.8 years), and in oncology clinics from 2 to 18 years (mean = 10.4 years). Participants had a median rating of "somewhat comfortable" for comfort with populations who are sexual minorities or whose gender identity is different than their own, and a median rating of "absolutely comfortable" for comfort with collecting SOGI data. Qualitative interviews illuminated that all the participants requested either a much longer training session or multiple training sessions to delve deeper into specific topics. Topics requested include specific sessions on each of the populations under the LGBTQ+ umbrella, as well as intersectionality for understanding social inequality. CONCLUSIONS: This study supports previous research showing the importance of patient navigator training for diverse populations, especially LGBTQ+ populations. We add to the research focused on oncology settings, and more specifically, breast cancer clinics. Overall, the patient navigators practicing in this highly academic setting were knowledgeable and comfortable working with LGBTQ+ populations yet yearned to learn more. Adding an intersectional perspective during the training helped the participants connect this issue of patient equity with other issues, which was powerful for them. This training can be expanded to include patient navigators with community experience or working in other types of medical settings, to patient navigators working with individuals with diagnoses of other tumor types, and to clinicians.
Tipre M, Winters S, Kearns A
… +4 more, Davis M, Gero J, Eckstrand K, Baskin ML
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671537
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BACKGROUND: Sexual and gender minorities (SGM) experience health disparities across cancer care continuum. However, inconsistent sexual orientation and gender identity (SOGI) data collection precludes measurement of the...BACKGROUND: Sexual and gender minorities (SGM) experience health disparities across cancer care continuum. However, inconsistent sexual orientation and gender identity (SOGI) data collection precludes measurement of the burden, and points to intervene. Comprehensive cancer centers (CCC) and their network hospitals are integrating SOGI data collection in their electronic medical records (EMRs), but significant challenges and barriers remain in data completion. METHODS: We evaluated the completeness of SOGI data in EMRs between 2021 and 2023 for cancer registry patients from 3 of the 54 CCC network hospitals/clinics in western PA used descriptive and bivariate statistics to compare between those with completed data and those that did not. RESULTS: Results found 12% of patients with completed SOGI data with notable differences by sex-at-birth, urban/rural status, and age. SOGI data completion rates increased each year significantly but overall remained low. CONCLUSION: Strong leadership, culturally sensitive education of clinical, research staff and patients, routine monitoring of SOGI data, and education of SGM on self-advocacy can address some of these gaps.
Bansal-Travers M, Carl E, Mullin S
… +2 more, Hyland A, Rodriguez EM
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671536
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Substantial gaps exist in person-centered care to patients who identify as sexual and gender minorities. This project's main objective was to understand acceptability, feasibility, assets, and challenges around implement...Substantial gaps exist in person-centered care to patients who identify as sexual and gender minorities. This project's main objective was to understand acceptability, feasibility, assets, and challenges around implementation of standardized sexual orientation and gender identity measures at the patient, provider, and organizational level at one National Cancer Institute-designated comprehensive cancer center. This analysis focuses on sexual orientation and gender identity data collected from October 2023 to October 2024. In addition, qualitative interviews were conducted with 100 patients and 30 clinicians to evaluate the impact of these questions on clinical experience. This study found that most patients provided valid responses to gender identity, sex at birth, relationship status, preferred name, preferred pronouns, and sexual orientation questions. Examination of the qualitative data suggests 3 main themes: support for sexual orientation and gender identity measures, appreciate inclusivity, and concern about sexual orientation and gender identity measures and implications for care. Findings from this study can contribute to the foundation for evidence-based recommendations for sexual orientation and gender identity data collection to provide cancer care that meets the needs of this medically underserved community.
Zamani SA, Pérez-Morales J, Yang MJ
… +2 more, Quinn GP, Schabath MB
J Natl Cancer Inst Monogr
· 2025 Jul · PMID 40671535
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BACKGROUND: Lack of sexual orientation and gender identity (SOGI) collection hinders the ability to identify cancer disparities, create opportunities for improvement, and reveal the burden of cancer among sexual and gend...BACKGROUND: Lack of sexual orientation and gender identity (SOGI) collection hinders the ability to identify cancer disparities, create opportunities for improvement, and reveal the burden of cancer among sexual and gender minority (SGM) populations. Our institution is one of the first NCI-Designated Comprehensive Cancer Centers to collect SOGI as standard-of-care demographics. METHODS: This analysis includes 118 320 patients who came to the H. Lee Moffitt Cancer Center & Research Institute ("Moffitt") between January 1, 2016 and December 31, 2023 and completed the institutional standard-of-care electronic patient questionnaire. Descriptive analyses were conducted to assessed overall and age-specific differences between SGM and non-SGM patients (ie, cisgender-heterosexual) for demographics, SOGI disclosure, clinical covariates, and psychosocial and quality-of-life needs. RESULTS: Compared with non-SGM patients, SGM patients were statistically significant younger, single, self-identified as racial and ethnic minorities, reported higher psychosocial and quality-of-life needs, and had higher-than-expected rates for several specific cancer sites. CONCLUSIONS: Revealing these real-world cancer disparities among SGM patients based on only 7 years of SOGI data collection highlights the fundamental importance of systematic collection of this demographic information for identifying and eventually mitigating health disparities.
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989045
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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...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.
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989044
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Interpreting cancer clinical trial results often depends on addressing issues of multiplicity. When testing multiple hypotheses, unreliable findings can occur by chance due to the inflation of the type I error rate, the...Interpreting cancer clinical trial results often depends on addressing issues of multiplicity. When testing multiple hypotheses, unreliable findings can occur by chance due to the inflation of the type I error rate, the probability of mistakenly rejecting the null hypothesis when the null hypothesis is true. In this setting, researchers may often set the type I error rate (or the alpha level) low to limit false positive findings and the interpretation of a causal relationship where none exists. Conversely, overly conservative type I error control may result in declaring findings, that do not meet multiplicity-adjusted alpha levels, as false when they are actually true, reducing opportunities for new discovery. This presentation focuses on multiplicity adjustment in the context of clinical trials conducted within the NCI's Community Oncology Research Program (NCORP). Because federally sponsored trials often require long-term participation from patients and represent a substantial investment by taxpayers, striking the right balance between optimizing what is learned from these trials, while avoiding false positive results, should be a priority.
Mazza GL, Culakova E, Enserro DM
… +2 more, Dignam JJ, Unger JM
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989043
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Examining treatment effects in subgroups of patients defined by demographic, genetic, or clinical characteristics is increasingly of interest given the pursuit of personalized medicine and the importance of representatio...Examining treatment effects in subgroups of patients defined by demographic, genetic, or clinical characteristics is increasingly of interest given the pursuit of personalized medicine and the importance of representation and equity in treatment decisions. The magnitude or even the direction of the treatment effect may vary across subgroups, and these differential treatment effects could have clinical implications. Subgroup analyses require caution in their interpretation, however, because of the high probability of a false-positive or false-negative conclusion. We outline study design and analysis considerations for responsibly investigating and reporting differential treatment effects across subgroups in oncology trials, with examples from the National Cancer Institute's National Clinical Trials Network and Community Oncology Research Program. Recommendations include ensuring appropriate representation of patients from subgroups of interest, recognizing power and multiplicity limitations, and treating exploratory subgroup analyses as hypothesis generating rather than practice changing.
Monge C, Eldridge L, Pearlman PC
… +6 more, Venkatesh V, Tregear M, Loehrer PJ, Galassi A, Gopal S, Ginsburg O
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989041
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Patient-centered clinical trials prioritize the patient experience and outcomes that matter most to those affected by cancer. By centering on patient values and experiences, patient-centered outcomes research generates e...Patient-centered clinical trials prioritize the patient experience and outcomes that matter most to those affected by cancer. By centering on patient values and experiences, patient-centered outcomes research generates evidence to inform policies and practices, facilitating more personalized and effective cancer care. This manuscript explores the importance of patient-centered approaches in the global context, emphasizing challenges and opportunities for substantive patient engagement and the integration of patient-reported measures in clinical therapeutic trials in low- and middle-income countries. Despite important barriers such as limited infrastructure and funding constraints, leveraging innovative strategies and investing in research infrastructure and regulatory harmonization initiatives can enhance the capacity of low- and middle-income countries to conduct high-quality research and address the global burden of cancer more effectively. Through these efforts, patient-centered care and research can be extended to underserved populations, ensuring equitable access to cancer care worldwide.
Nuño MM, Pugh SL, Ji L
… +3 more, Piao J, Dignam JJ, Steingrimsson JA
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989040
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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 accelerat...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.
Snavely AC, Gunn HJ, Lee JW
… +11 more, Pugh SL, Barlow WE, Culakova E, Arnold KB, Kittel CA, Smith S, Hanlon BM, Tan AD, Dockter T, Zahrieh D, Dressler EV
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989039
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The intracluster correlation coefficient (ICC) measures the correlation of observations within clusters and is a key parameter for power and sample size calculations for cluster randomized trials (CRTs). To facilitate th...The intracluster correlation coefficient (ICC) measures the correlation of observations within clusters and is a key parameter for power and sample size calculations for cluster randomized trials (CRTs). To facilitate the design of future CRTs within the National Cancer Institute Community Oncology Research Program (NCORP), all studies from the NCORP website were reviewed to identify completed CRTs. ICCs for primary and secondary outcomes (when available) were ascertained from these trials and summarized in this article as a resource for future trial development. Although ICCs are relatively small for many outcome cluster combinations, that is not always the case, so consideration should always be given to the specific outcome of interest, trial design, and type of cluster when estimating an ICC to facilitate trial development.
Bandos H, Torres-Saavedra PA, Culakova E
… +7 more, Gunn HJ, Lee MK, Duan F, Cecchini RS, Unger JM, Dueck AC, Steingrimsson JA
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989038
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Patient-reported outcomes (PROs) are often collected in cancer clinical trials. Data obtained from trials with PROs are essential in evaluating participant experiences relating to symptoms, financial toxicity, or health-...Patient-reported outcomes (PROs) are often collected in cancer clinical trials. Data obtained from trials with PROs are essential in evaluating participant experiences relating to symptoms, financial toxicity, or health-related quality of life. Although most features of clinical trial design, implementation, and analyses apply to trials with PROs, several considerations are unique. In this paper, we focus on specific issues such as selection of the tool, timing and frequency of assessments, and data collection methods. We discuss how the estimand framework can be used in connection with PROs, properties of common estimation methods, and handling of missing outcomes. With a plethora of literature available, we aim to summarize best practices and pragmatic approaches to the design and analysis of the studies incorporating PROs.
Hu P, Steingrimsson JA, Cole E
… +8 more, Cormack J, Dunn BK, Gatsonis C, Lee C, Li N, Pisano ED, He J, Kramer BS
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989037
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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 can...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.
J Natl Cancer Inst Monogr
· 2025 Mar · PMID 39989036
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The statistical problem of multiplicity is concerned with making protected multiple inferences and their valid interpretation in a particular study. Most discussions of multiplicity focus on the increase of type I error...The statistical problem of multiplicity is concerned with making protected multiple inferences and their valid interpretation in a particular study. Most discussions of multiplicity focus on the increase of type I error rate if testing is done without any adjustment, with only a few papers discussing its ramifications for type II errors/power. We provide a survey of main approaches to protected inference in biomedical studies, touching on procedures to control the family-wise error rate, false discovery rate, as well as false discovery exceedance probability. We discuss several notions of power including total power, average power, and power defined as exceedance probability for the true positive proportion. We provide commentary on best practices for adjusting for multiplicity in both type I and type II errors within families defined by primary, secondary, and exploratory endpoints in clinical trials and in experimental studies.