Evolution of community outreach and engagement at National Cancer Institute-Designated Cancer Centers, an evolving journey.

Cancer mortality rates have declined during the last 28 years, but that process is not equitably shared. Disparities in cancer outcomes by race, ethnicity, socioeconomic status, sexual orientation and gender identity, and geographic location persist across the cancer care continuum. Consequently, community outreach and engagement (COE) efforts within National Cancer Institute-Designated Cancer Center (NCI-DCC) catchment areas have intensified during the last 10 years as has the emphasis on COE and catchment areas in NCI's Cancer Center Support Grant applications. This review article attempts to provide a historic perspective of COE within NCI-DCCs. Improving COE has long been an important initiative for the NCI, but it was not until 2012 and 2016 that NCI-DCCs were required to define their catchment areas rigorously and to provide specific descriptions of COE interventions, respectively. NCI-DCCs had previously lacked adequate focus on the inclusion of historically marginalized patients in cancer innovation efforts. Integrating COE efforts throughout the research and operational aspects of the cancer centers, at both the patient and community levels, will expand the footprint of COE efforts within NCI-DCCs. Achieving this change requires sustained commitment by the centers to adjust their activities and improve access and outcomes for historically marginalized communities.

The role of community outreach and engagement in evaluation of NCI Cancer Center Support Grants.

PURPOSE: National Cancer Institute (NCI)-designated cancer centers are required to consider their impact on the catchment area they serve. These activities are facilitated by community outreach and engagement (COE) activities as specified in the Cancer Center Support Grant (CCSG) request for applications. While the critical importance of COE activities to NCI-designated cancer centers is well known, it is less clear what impact the COE component has on the overall CCSG merit descriptor and score. METHODS: We undertook an online survey of all 62 NCI-designated Comprehensive and Clinical centers who reported their COE merit descriptor and overall CCSG priority score as of Fall 2021. RESULTS: Of 48 (77%) of responding centers, we identified a strong correlation between the COE merit descriptor and the overall numerical CCSG score received by the center (Spearman's rank correlation coefficient r = 0.360, p = 0.0053). When stratifying this relationship by center type, we observed a very strong correlation between COE and CCSG ratings for comprehensive cancer centers (n = 40; r = 0.544; p = 0.0003) but not for non-comprehensive cancer centers (n = 8; r = 0.073; p = 0.864). CONCLUSION: COE component merit descriptors for comprehensive cancer center CCSG evaluations are strongly correlated with the overall cancer center review score.

Virtual multi-institutional tumor board: a strategy for personalized diagnoses and management of rare CNS tumors.

PURPOSE: Multidisciplinary tumor boards (MTBs) integrate clinical, molecular, and radiological information and facilitate coordination of neuro-oncology care. During the COVID-19 pandemic, our MTB transitioned to a virtual and multi-institutional format. We hypothesized that this expansion would allow expert review of challenging neuro-oncology cases and contribute to the care of patients with limited access to specialized centers. METHODS: We retrospectively reviewed records from virtual MTBs held between 04/2020-03/2021. Data collected included measures of potential clinical impact, including referrals to observational or therapeutic studies, referrals for specialized neuropathology analysis, and whether molecular findings led to a change in diagnosis and/or guided management suggestions. RESULTS: During 25 meetings, 32 presenters discussed 44 cases. Approximately half (n = 20; 48%) involved a rare central nervous system (CNS) tumor. In 21% (n = 9) the diagnosis was changed or refined based on molecular profiling obtained at the NIH and in 36% (n = 15) molecular findings guided management. Clinical trial suggestions were offered to 31% (n = 13), enrollment in the observational NCI Natural History Study to 21% (n = 9), neuropathology review and molecular testing at the NIH to 17% (n = 7), and all received management suggestions. CONCLUSION: Virtual multi-institutional MTBs enable remote expert review of CNS tumors. We propose them as a strategy to facilitate expert opinions from specialized centers, especially for rare CNS tumors, helping mitigate geographic barriers to patient care and serving as a pre-screening tool for studies. Advanced molecular testing is key to obtaining a precise diagnosis, discovering potentially actionable targets, and guiding management.

Are NCI Cancer Centers Providing Adolescents and Young Adults With Cancer Focused Clinical Services? A National Survey.

BACKGROUND: This study sought to evaluate the current services and delivery models of adolescent and young adult oncology (AYAO)-specific programs at NCI-designated Cancer Centers (NCI-CCs). PATIENTS AND METHODS: NCI, academic, and community cancer centers were electronically sent surveys from October to December 2020 and administered via REDCap. RESULTS: Survey responses were received from 50 of 64 (78%) NCI-CCs, primarily completed by pediatric oncologists (53%), adult oncologists (11%), and social workers (11%). Half (51%) reported an existing AYAO program, with most (66%) started within the past 5 years. Although most programs combined medical and pediatric oncology (59%), 24% were embedded within pediatrics alone. Most programs saw patients aged 15 (55%) to 39 years (66%) mainly via outpatient clinic consultation (93%). Most centers reported access to a range of medical oncology and supportive services, but dedicated services specifically for adolescent and young adults (AYAs) were available at a much lower extent, such as social work (98% vs 58%) and psychology (95% vs 54%). Although fertility preservation was offered by all programs (100%), only two-thirds of NCI centers (64%) reported providing sexual health services to AYAs. Most NCI-CCs (98%) were affiliated with a research consortium, and a lesser extent (73%) reported collaboration between adult and pediatric researchers. Nearly two-thirds (60%) reported that AYA oncology care was important/very important to their respective institution and reported providing good/excellent care to AYAs with cancer (59%), but to a lesser extent reported good/excellent research (36%), sexual health (23%), and education of staff (21%). CONCLUSIONS: Results of this first-ever national survey to assess AYAO programs showed that only half of NCI-CCs report having a dedicated AYAO program, and that areas of improvement include staff education, research, and sexual health services for patients.

Children's Oncology Group 2023 blueprint for research: Cancer care delivery research.

The National Cancer Institute (NCI) has a 40-year history of initiatives to encourage the participation of community oncology sites into clinical trials research and clinical care. In 2014, the NCI re-organized to form the NCI Community Oncology Research Program (NCORP) network across seven research bases, including the Children's Oncology Group (COG), and numerous community sites. The COG portfolio for Cancer Care Delivery Research (CCDR), mirroring the larger NCORP network, has included two studies addressing guideline congruence, as an important marker of quality cancer care, and another focusing on financial toxicity, addressing the pervasive problems of healthcare cost. CCDR is a cross-cutting field that frequently examines intersectional aspects of healthcare delivery. With that in mind, we explicitly define domains of CCDR to propel our research agenda into the next phase of the NCORP CCDR program while acknowledging the complex and dynamic fields of clinical care, policy level decisions, research findings, and needs of communities served by the NCORP network that will inform the subsequent research questions. To ensure programmatic success, we will engage a broad interdisciplinary group of investigators and clinicians with expertise and dedication to community oncology and the populations they serve.

Adherence to a priori dietary patterns in relation to obesity: results from two cycles of the Canadian National Nutrition Survey.

OBJECTIVE: To test whether adherence to the Mediterranean diet, the Dietary Approaches to Stop Hypertension (DASH) or a dietary pattern in-line with the 2015-2020 Dietary Guidelines for Americans (DGA) was associated with obesity. DESIGN: 24-h dietary recall data from the Canadian Community Health Survey (CCHS)-Nutrition, 2004 and 2015 cycles, were analysed. Diet quality index scores were computed for the Mediterranean-Style Dietary Pattern Score (MSDPS), a DASH index and the 2015 Dietary Guidelines for Americans Adherence Index (DGAI). Higher scores indicated greater adherence. Association between scores and obesity was examined using logistic regression, adjusting for age, sex, physical activity, smoking status, sequence of dietary recall and alcohol and energy intake. SETTING: Canada (excluding territories and the institutionalised population). PARTICIPANTS: Canadian adults (≥ 18 years), non-pregnant and non-breast-feeding; 11 748 from CCHS 2004 and 12 110 from CCHS 2015. The percentage of females in each sample was 50 %. RESULTS: Mean MSDPS, DASH and DGAI scores were marginally but significantly higher in CCHS 2015 than in CCHS 2004. Those affected by obesity obtained lower scores for all indexes in CCHS 2004 (OR 10th v. 90th percentile for DASH: 2·23 (95 % CI 1·50, 3·32), DGAI: 3·01 (95 % CI 1·98, 4·57), MSDPS: 2·02 (95 % CI 1·14, 3·58)). Similar results were observed in CCHS 2015; however, results for MSDPS were not significant (OR 10th v. 90th percentile for DASH: 2·45 (95 % CI 1·72, 3·49), DGAI: 2·73 (95 % CI 1·85, 4·03); MSDPS: 1·30 (95 % CI 0·82, 2·06)). CONCLUSION: Following DASH or the 2015-2020 DGA was associated with a lower likelihood of obesity. Findings do not indicate causation, as the data are cross-sectional.

Consensus Building to Inform Common Evaluation Metrics for the Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) Program.

Common measures facilitate the standardization of assessment practices. These types of measures are needed to develop instruments that can be used to assess the overall effectiveness of the U54 Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) funding mechanism. Developing common measures requires a multi-phase process. Stakeholders used the nominal group technique, a consensus development process, and the Grid-Enabled Measures (GEM) platform to identify evaluation constructs and measures of those constructs. Use of these instruments will ensure the implementation of standardized data elements, facilitate data integration, enhance the quality of evaluation reporting to the National Cancer Institute, foster comparative analyses across centers, and support the national assessment of the CPACHE program.

Racial disparity in distant recurrence-free survival in patients with localized breast cancer: A pooled analysis of National Surgical Adjuvant Breast and Bowel Project trials.

BACKGROUND: Black race is associated with worse outcome in patients with breast cancer. The distant relapse-free survival (DRFS) between Black and White women with localized breast cancer who participated in National Cancer Institute-sponsored clinical trial was evaluated. METHODS: Pooled data were analyzed from 8 National Surgical Adjuvant Breast and Bowel Project (NSABP) trials including 9702 women with localized breast cancer treated with adjuvant chemotherapy (AC, n = 7485) or neoadjuvant chemotherapy (NAC, n = 2217), who self-reported as Black (n = 1070) or White (n = 8632) race. The association between race and DRFS was analyzed using log-rank tests and multivariate Cox regression. RESULTS: After adjustment for covariates including age, tumor size, nodal status, body mass index and taxane use, and treatment (AC vs NAC), Black race was associated with an inferior DRFS in estrogen receptor-positive (ER+; hazard ratio [HR], 1.24; 95% CI, 1.05-1.46; P = .01), but not in ER- disease (HR, 0.97; 95% CI, 0.83-1.14; P = .73), and significant interaction between race and ER status was observed (P = .03). There was no racial disparity in DRFS among patients with pathologic complete response (pCR) (log-rank P = .8). For patients without pCR, Black race was associated with worse DRFS in ER+ (HR, 1.67; 95% CI, 1.14-2.45; P = .01), but not in ER- disease (HR, 0.91; 95% CI, 0.65-1.28; P = .59). CONCLUSIONS: Black race was associated with significantly inferior DRFS in ER+ localized breast cancer treated with AC or NAC, but not in ER- disease. In the NAC group, racial disparity was also observed in patients with residual ER+ breast cancer at surgery, but not in those who had pCR. LAY SUMMARY: Black women with breast cancer have worse outcomes compared with White women. We investigated if this held true in the context of clinical trials that provide controlled treatment setting. Black women with cancer expressing estrogen receptors (ERs) had worse outcome than White women. If breast cancers did not express ERs, there was no racial disparity in outcome. We also observed racial disparity in women who received chemotherapy before their cancer was removed, but only if they had cancer expressing ERs and residual disease on completion of treatment. If the cancer disappeared with presurgical chemotherapy, there was no racial disparity.

Enrollment of adolescent and young adult patients newly diagnosed with cancer in NCI CTEP-sponsored clinical trials before and after launch of the NCI National Clinical Trials Network.

BACKGROUND: Participation of adolescents and young adults (AYAs) in oncology clinical trials is important to ensure adequate opportunities for AYA patients to contribute to, and benefit from, advances in cancer treatment. METHODS: Accrual data for National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) cooperative group-led treatment trials were examined to assess enrollment of newly diagnosed AYA patients (15-39 years) during the period 2004-2019, with particular interest in comparing enrollment before launch of the NCI National Clinical Trials Network (NCTN) to after. All phase 2, 2/3, and 3 trials activated during the period between January 1, 2004, and December 31, 2019, were identified (n = 1568) and reduced to a set of 304 that met predetermined criteria to focus on cooperative group-led trials that involved therapy for newly diagnosed cancer and had age eligibility overlapping the AYA range. The proportion of AYA patients relative to total accrual, along with 95% bootstrapped CI was calculated for patients enrolled pre-NCTN and post-NCTN. RESULTS: AYA accrual comprised 9.5% (95% CI, 7.6-11.8) pre-NCTN compared with 14.0% (95% CI, 9.9-18.3) post-NCTN. The mean difference in proportions post-NCTN compared with pre-NCTN was 4.4% (0.7%-8.3%). CONCLUSIONS: These results indicate an increase in AYA participation in trials conducted within the NCTN relative to the pre-NCTN period. This suggests an awareness and utilization of NCTN trials for AYAs with cancer.

Sustainability analysis of Finnish pre-schoolers' diet based on targets of the EAT-Lancet reference diet.

PURPOSE: The EAT-Lancet reference diet is a healthy plant-based diet produced within planetary boundaries. To inform the food system transformation, we compared Finnish pre-schoolers' food consumption with the reference diet's food group targets. METHODS: Food record data for 3- to 6-year-old pre-schoolers were collected in the cross-sectional DAGIS survey. Ingredients of composite dishes were available in the data. In addition, we manually decomposed industrial products such as sausages and biscuits by estimating the shares of ingredients. We also estimated the consumption of added sugars and converted the consumption of dairy products into milk equivalents. We used usual intake modelling to estimate the mean consumption and the proportion of children who met the reference diet's targets. We set the target amounts separately for 3- to 4-year-olds and 5- to 6-year-olds in grams by proportioning the published target amounts (assuming a 2500 kcal diet) to the children's mean reported energy intake. RESULTS: For both age groups (3- to 4-year-olds, n = 460; 5- to 6-year-olds, n = 402), the daily mean consumption of whole grains, vegetables, legumes, nuts, and unsaturated oils was below targets, whereas the consumption of red meat, dairy foods, tubers, and added sugars was above targets. The consumption of fruit and fish was in line with targets. CONCLUSION: To comply with the reference diet's targets, major changes in the diets of Finnish children are needed. The key food groups targeted for higher consumption are whole grains and legumes and targeted for lower consumption red meat and dairy products.

Symptom science research conducted in community programs funded by the US National Cancer Institute: a 12-year review, 2008 to 2019.

PURPOSE: This study was conducted to describe the portfolio of symptom science research conducted through the community oncology network supported by the US National Cancer Institute during the 12-year period 2008 to 2019. METHODS: The National Cancer Institute conducted a retrospective review of the National Cancer Institute database to identify pediatric and adult symptom management studies that were opened between 2008 and 2019 in the community oncology network and to determine types of studies, accrual patterns, completed studies, and number of publications reporting clinical trial results. RESULTS: The NCI community oncology network conducted 109 symptom studies between 2008 and 2019. The majority of these studies were phase II and III clinical trials. Neurotoxicities were the most frequently occurring symptom studied, with the majority of those focused on neurocognitive impairments. Gastrointestinal symptoms, pain, and fatigue were the next most frequently studied. A variety of interventions were utilized including pharmacologic, behavioral, complementary and alternative medicines, and radiation therapy. Accrual to symptom studies ranged from a low of 896 participants in 2008 to a high of 3468 participants in 2012. The number of open studies ranged from 8 in 2008 to 35 in 2012. CONCLUSIONS: Examining the symptom science portfolio of the NCI community oncology network has identified research gaps and has highlighted the need to focus on a mechanistic understanding of symptoms and phenotyping of patients experiencing cancer and treatment-related symptoms. Subsequently, targeted interventions can be developed to prevent or treat these symptoms.

Design and synthesis of novel N-[3-(benzimidazol-2-ylamino)phenyl]amine and N-[3-(benzoxazol-2-ylamino)phenyl]amine derivatives as potential anticancer agents.

In this contribution, we report the design, synthesis and cytotoxicity studies of a series of N-[3-(benzimidazol-2-yl-amino)phenyl]amine and N-[3-(benzoxazol-2-ylamino)phenyl]amine derivatives. In vitro cytotoxicity assay of 26 selected compounds was carried out at National Cancer Institute (NCI), USA. Out of them, compounds 10e (NSC D-762842/1) and 11s (NSC D-764942/1) have shown remarkable cytotoxicity with GI50 values ranging between "0.589-14.3 µM" and "0.276-12.3 µM," respectively, in the representative nine subpanels of human tumor cell lines. Further, flow cytometry analysis demonstrated that compound 10e exerted cell cycle arrest at G2/M phase and showed dose-dependent enhancement in apoptosis in K-562 leukemia cancer cells.

Use of a clinical trial screening tool to enhance patient accrual.

BACKGROUND: Clinical trial patient accrual continues to be challenging despite the identification of multiple physician, patient, and system barriers. Expanded collection of demographic data, including socioeconomic status (employment, income, education) and comorbidities, can enhance our understanding of the identified barriers, inform the development of interventions to overcome these barriers, and recognize their impact on treatment outcomes. A clinical trials screening tool was developed to collect expanded demographic data and barriers to trial enrollment; it has been implemented in the National Cancer Institute Clinical Oncology Research Program. The purpose of this article is to describe the development and implementation of the tool and to share information obtained during the first 43 months of its use. METHODS: There were 19,373 entries collected; 74% of those screened enrolled in a clinical trial. Demographic characteristics were compared between those screened and those enrolled. They varied significantly between the groups. RESULTS: Reasons for nonenrollment included ineligibility (50%), eligible but declined (47%), eligible but physician declined to offer participation (2%), and eligible but the study was suspended (1%). The most common reasons for ineligibility were failure to meet the protocol-specific stage of cancer, the presence of comorbidities, and the symptom-eligibility score was not met. The most common reason for eligible patients declining participation was that they had no desire to participate in research. CONCLUSIONS: The tool provides valuable information about the characteristics of individuals who are screened and enrolled in National Cancer Institute-sponsored trials, as well as about barriers to enrollment in trials. The data also inform protocol development and interventions at the patient, provider, and institutional level.

The 50 years' war: The history and outcomes of the National Cancer Act of 1971.

The National Cancer Act of 1971 instigated 50 years of momentum that raised the federal investment in cancer research from $500 million in 1972 to $6.5 billion in 2021. This investment has fueled basic, translational, and clinical research that has had a tremendous impact on our understanding of cancer and our ability to prevent, diagnose, and treat it. It has also affected many other diseases.

Expenditures among young adults with acute lymphoblastic leukemia by site of care.

BACKGROUND: Individuals diagnosed with acute lymphoblastic leukemia (ALL) between the ages of 22 and 39 years experience worse outcomes than those diagnosed when they are 21 years old or younger. Treatment at National Cancer Institute-designated Comprehensive Cancer Centers (CCC) mitigates these disparities but may be associated with higher expenditures. METHODS: Using deidentified administrative claims data (OptumLabs Data Warehouse), the cancer-related expenditures were examined among patients with ALL diagnosed between 2001 and 2014. Multivariable generalized linear model with log-link modeled average monthly health-plan-paid (HPP) expenditures and amount owed by the patient (out-of-pocket [OOP]). Cost ratios were used to calculate excess expenditures (CCC vs non-CCC). Incidence rate ratios (IRRs) compared CCC and non-CCC monthly visit rates. Models adjusted for sociodemographics, comorbidities, adverse events, and months enrolled. RESULTS: Clinical and sociodemographic characteristics were comparable between CCC (n = 160) and non-CCC (n = 139) patients. Higher monthly outpatient expenditures in CCC patients ($15,792 vs $6404; P < .001) were driven by outpatient hospital HPP expenditures. Monthly visit rates and per visit expenditures for nonchemotherapy visits (IRR = 1.6; P = .001; CCC = $8247, non-CCC = $1191) drove higher outpatient hospital expenditures among CCCs. Monthly OOP expenditures were higher at CCCs for outpatient care (P = .02). Inpatient HPP expenditures were significantly higher at CCCs ($25,918 vs $13,881; ꞵ = 0.9; P < .001) before accounting for adverse events but were no longer significant after adjusting for adverse events (ꞵ = 0.4; P = .1). Hospitalizations and length of stay were comparable. CONCLUSIONS: Young adults with ALL at CCCs have higher expenditures, likely reflecting differences in facility structure, billing practices, and comprehensive patient care. It would be reasonable to consider CCCs comparable to the oncology care model and incentivize the framework to achieve superior outcomes and long-term cost savings. LAY SUMMARY: Health care expenditures in young adults (aged 22-39 years) with acute lymphoblastic leukemia (ALL) are higher among patients at National Cancer Institute-designated Comprehensive Cancer Centers (CCC) than those at non-CCCs. The CCC/non-CCC differences are significant among outpatient expenditures, which are driven by higher rates of outpatient hospital visits and outpatient hospital expenditures per visit at CCCs. Higher expenditures and visit rates of outpatient hospital visits among CCCs may also reflect how facility structure and billing patterns influence spending or comprehensive care. Young adults at CCCs face higher inpatient HPP expenditures; these are driven by serious adverse events.

Communication research at the National Cancer Institute, 2013-2019: a grant portfolio analysis.

PURPOSE: To analyze communication-focused grants funded by the National Cancer Institute (NCI) between fiscal years 2013 and 2019 to provide insight into the characteristics of funded projects and identify promising areas for future research. METHODS: iSearch, a portfolio analysis tool, was queried to identify communication-related grants funded by NCI. Abstracts and specific aims were coded for key study characteristics. 344 unique competing grants with a substantial communication component were included in the final analysis. SAS version 9.4 was used to calculate code frequencies. RESULTS: Most communication grants focused on cancer prevention (n = 197), with fewer targeting diagnosis, treatment, survivorship, or end-of-life. Tobacco product use was the most frequently addressed topic (n = 128). Most grants targeted or measured outcomes at the individual (n = 332) or interpersonal level (n = 127). Cancer patients/survivors (n = 101) and healthcare providers (n = 63) were often the population of focus, while caregivers or those at increased risk for cancer received less attention. Studies were often based in healthcare settings (n = 125); few studies were based in schools or worksites. Many grants employed randomized controlled trials (n = 168), but more novel methods, like optimization trials, were uncommon. CONCLUSION: NCI's support of health communication research covers a diverse array of topics, populations, and methods. However, the current analysis also points to several promising opportunities for future research, including efforts focused on communication at later stages of the cancer control continuum and at multiple levels of influence, as well as studies that take advantage of a greater diversity of settings and leverage novel methodological approaches.

Building infrastructure at the National Cancer Institute to support metabolomic analyses in epidemiological studies.

In recent years, metabolomic analyses have been increasingly performed in studies with an epidemiological design. Since 2012, the National Cancer Institute has recognized the importance of supporting these efforts by strategically building resources and infrastructure to move this area forward. This review outlines those efforts, including building infrastructure, leveraging existing resources, establishing the COnsortium of METabolomics Studies (COMETS), and improving rigor and reproducibility.

National Cancer Institute support for targeted alpha-emitter therapy.

BACKGROUND: Radiopharmaceutical targeted therapy (RPT) has been studied for decades; however, recent clinical trials demonstrating efficacy have helped renewed interest in the modality. METHODS: This article reviews National Cancer Institute (NCI)'s support of RPT through communication via workshops and interest groups, through funding extramural programs in academia and small business, and through intramural research, including preclinical and clinical studies. RESULTS: NCI has co-organized workshops and organized interest groups on RPT and RPT dosimetry to encourage the community and facilitate rigorous preclinical and clinical studies. NCI has been supporting RPT research through various mechanisms. Research has been funded through peer-reviewed NCI Research and Program Grants (RPG) and NCI Small Business Innovation Research (SBIR) Development Center, which funds small business-initiated projects, some of which have led to clinical trials. The NCI Cancer Therapy Evaluation Program (CTEP)'s Radiopharmaceutical Development Initiative supports RPT in NCI-funded clinical trials, including Imaging and Radiation Oncology Core (IROC) expertise in imaging QA and dosimetry procedures. Preclinical targeted a-emitter therapy (TAT) research at the NCI's intramural program is ongoing, building on foundational work dating back to the 1980s. Ongoing "bench-to-bedside" efforts leverage the unique infrastructure of the National Institutes of Health's (NIH) Clinical Center. CONCLUSION: Given the great potential of RPT, our goal is to continue to encourage its development that will generate the high-quality evidence needed to bring this multidisciplinary treatment to patients.

Introduction to the SIMPLE Macro, a Tool to Increase the Accessibility of 24-Hour Dietary Recall Analysis and Modeling.

BACKGROUND: Information on long-term dietary intake is often required for research or program planning, but surveys routinely use short-term assessments such as 24-h recalls (24HRs). Methods to reduce the impact of within-person variation in 24HRs, such as the National Cancer Institute (NCI) method, typically require extensive training and skill. OBJECTIVES: We introduce the Simulating Intake of Micronutrients for Policy Learning and Engagement (SIMPLE) macro, a new tool to increase the accessibility of 24HR analysis. We explain the underlying theory behind the tool and provide examples of potential applications. METHODS: The SIMPLE macro connects the core NCI statistical code to estimate usual intake distributions and includes additional code to enable advanced analyses such as predictive modeling. The related SIMPLE-Iron macro applies the full probability method to estimate inadequate iron intake, and the SIMPLE-1D macro is used for descriptive or modeling analyses of data with a single 24HR per person. The macros and associated documentations are freely available. We analyzed data from the US National Health and Nutrition Examination Survey (NHANES) and the Cameroon National Micronutrient Survey to compare the SIMPLE macro to 1) the core NCI code using the Estimated Average Requirement cut point method, and 2) the IMAPP software for iron only, and to demonstrate the applications of the SIMPLE macro for estimating usual intake and predictive modeling. RESULTS: The SIMPLE macro generates identical results to the core NCI code. The SIMPLE-Iron macro also produces estimates of inadequate iron intake comparable to the IMAPP software. The examples demonstrate application of the SIMPLE macro to 1) descriptive analyses of nutrient intake from food and supplements (NHANES), and 2) analyses accounting for breast-milk nutrient intake and modeling fortification and supplementation programs (Cameroon). CONCLUSIONS: The SIMPLE macros may facilitate the analysis and modeling of dietary data to inform nutrition research, programs, and policy.

Reporting of health-related quality of life endpoints in National Cancer Institute-supported cancer treatment trials.

BACKGROUND: The importance of capturing and reporting health-related quality of life (HRQOL) in clinical trials has been increasingly recognized in the oncology field. As a result, the National Cancer Institute (NCI) began to provide support for correlative HRQOL studies in cancer treatment trials. The current study was conducted to assess the publication rate of HRQOL correlative studies in NCI-supported treatment trials and to identify potential factors positively or negatively associated with publication rates. METHODS: The NCI conducted a retrospective review of existing NCI databases to identify cancer treatment trials that had obtained additional NCI funding for the assessment of HRQOL and to determine the extent to which funded HRQOL studies have been completed and published in a peer-reviewed journal. RESULTS: Of the 108 included trials, 58 (54%) had a parent trial (PT) publication; of these, 36 trials (62%) had a published HRQOL result: 20 as an independent publication and 16 that were included and/or reported in the PT publication. The length of time between trial activation and closure, as well as the specific cancer, appeared to be associated with the publication rates. CONCLUSIONS: The results of the current study demonstrated that approximately 45% of the PT publications were followed by a HRQOL publication within 1 year, to allow the knowledge to be used in patient treatment decision making. The authors believe the current analysis is an important first step toward a better understand of the challenges that researchers face when reporting HRQOL endpoints.