Introduction Progress in acute lymphoblastic leukemia (ALL) affecting adolescents and young adults (AYAs), aged 15-39 years, has been challenged by aggressive disease biology, low clinical trial participation, unique supportive care needs, and heterogeneity across treatment settings with lack of age-based standardized therapy. In 2012, the National Comprehensive Cancer Network (NCCN) first issued AYA ALL treatment guidelines. In the absence of formal evaluation of the 2012 NCCN guidelines on the delivery of guideline-concordant care at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practices, we conducted a qualitative study, as part of the Children’s Oncology Group-led cancer care delivery trial ACCL16N1CD. Methods Structured focus groups, moderated by study members, were convened to identify barriers and facilitators to NCCN guideline-concordant treatment delivery and documentation . Healthcare professionals at NCORP sites that activated ACCL16N1CD were invited to participate if they were involved in AYA ALL care. Nine focus groups were held with 55 participants. Nominal group technique was used to rank statements about delivery and documentation. Qualitative data were analyzed using directed content analysis methodology to describe facilitators and barriers and assess emerging themes. Results Five main themes were identified for delivery (Care Model, Care Organization, Supportive Care, Therapeutic Approach, Individual Factors [patient; provider]) and six for documentation (Care Model, Hospital Type, Care Organization, Supportive Care, Therapeutic Approach, Individual Factors) of NCCN-concordant treatment. Supportive Care was ranked first for delivery of guideline-concordant care and Care Organization was ranked first for documentation, with Individual Factors ranking close behind for both. Theme ranking varied by focus group type and professional roles of participants. Conclusion Identified barriers and facilitators impacting guideline-concordant care of AYA ALL across NCORPs were aligned with institutional supportive care resources, care organization for AYA, and individual factors. Top ranked statements may be utilized as implementation strategies in future care delivery trials.

BACKGROUND:Improvements in outcomes among children and adolescents diagnosed with cancer are attributable to many factors, including clinical trials such as those administered through the Children's Oncology Group (COG) as well as population-based resources such as the National Childhood Cancer Registry (NCCR). The objective of this study was to link COG trial data with the NCCR to evaluate overall enrollment patterns. METHODS:Data were received from the NCCR and COG that were linked using an array of variables, then compared to evaluate enrollment patterns in COG studies from 2007 to 2018. Multivariable logistic regression was used to identify characteristics associated with not being enrolled in a COG study. RESULTS:Among 134 696 NCCR patients with cancer, 51 062 matched with COG study enrollees. There were several differences in demographic and clinical characteristics between individuals enrolled and not enrolled in COG studies. Enrollment was higher among children aged from birth to 4 years compared with adolescents aged 15-19 years (53.7% vs 20.1%). Differences by race and ethnicity were also observed; for example, individuals who identified as non-Hispanic White were more likely to be enrolled than were individuals who identified as non-Hispanic Asian or Pacific Islander (38.8% vs 32.9%). In a multivariable logistic regression model, several characteristics were strongly associated with not being enrolled in a COG study, including age at diagnosis, year of diagnosis, race and ethnicity, and cancer type. CONCLUSION:Our results suggest that several groups are underrepresented in COG clinical trials. This information can help guide the prioritization of population groups for engagement in future studies.

PURPOSE Medication prior authorization (mPA) occurs commonly in US cancer care. While medical oncologists report potential harm resulting from this requirement, the impact of mPA in pediatric oncology is unknown. This study's primary aim was to test the feasibility of prospectively collecting multi-institutional data on mPA in pediatric oncology, while secondarily assessing for resultant delays in care. METHODS Pediatric patients with cancer were enrolled between September 2021 and December 2022 at three Children's Oncology Group institutions participating in the National Cancer Institute Community Oncology Research Program. Data collected for each mPA event included the name of the medication, indication, desired initiation date, and actual date administered. RESULTS Among 68 patients enrolled at three institutions, 38 (56%) were subject to at least one mPA. A total of 69 mPAs occurred in these 38 patients, with 36 (52%) for supportive care and 33 (48%) for treatment medications. Ultimately, 61 of 69 (88%) mPAs were approved as prescribed (33 of 33 treatment mPAs) with a range of 5-240 minutes of provider/staff time required to resolve. MPAs delayed care in 15 of 69 (22%) cases with a range of 1-21 days. Most providers reported minimal or no additional burden to characterizing mPA data. CONCLUSION Despite the complexity and variability of institutional mPA processes, it is feasible to prospectively collect multi-institutional mPA data. No cancer treatment mPA request led to alterations in prescriptions. Delays in care because of mPA affect roughly one quarter of pediatric patients with cancer, the consequences of which remain unknown.

BACKGROUND:Melanoma survivors have a high risk of developing second primary neoplasms, both cutaneous melanoma (SPCM) and non-cutaneous melanoma (SPNCM), but little is known about the survival impact of the diagnosis of SPCM and SPNCM. OBJECTIVES:To compare overall survival between melanoma survivors with first primary melanoma and SPCM/SPNCM by stage at diagnosis of second primary neoplasms. METHODS:Among cutaneous (CM) and non-cutaneous melanoma (NCM) survivors of all ages, SPCM (N = 7314) or SPNCM (N = 157) between 2004 and 2020 were identified from the Surveillance, Epidemiology, and End Results 17 Research Plus database. Flexible parametric modelling was conducted to evaluate the time-varying effect of SPCM and SPNCM, compared to single melanoma, on survival. RESULTS:Over the study period, 3.4% of patients had a SPCM (12.9% regional/distant-stage) and 0.1% had a SPNCM (36.3% regional/distant or unknown-stage). Compared with single CM, patients with SPCM (regional/distant-stage hazard ratio [HR] = 1.71, 95% confidence interval [CI] = 1.55-1.89; localized-stage HR = 1.09, CI = 1.01-1.18) and regional/distant-stage SPNCM (Year 1: HR = 1.56, CI = 0.81-3.03) had worse overall survival. Among NCM survivors, regional/distant-stage SPCM (HR = 2.67, CI = 1.73-4.13) had a more pronounced impact on decreased overall survival than localized-stage SPCM (HR = 1.19, CI = 0.71-1.99) when compared with single NCM, with similar trends seen for regional/distant-stage SPNCM (Year 2: HR = 1.39, CI = 0.76-2.54) relative to localized-stage SPNCM (Year 2: HR = 0.96, CI = 0.61-1.50). CONCLUSIONS:The reduction in survival among melanoma survivors with SPCM and SPNCM suggests the potential need for prevention and early detection of SPCM and SPNCM.

PURPOSE Database linkage between cancer registries and clinical trial consortia has the potential to elucidate referral patterns of children and adolescents with newly diagnosed cancer, including enrollment into cancer clinical trials. This study's primary objective was to assess the feasibility of this linkage approach. METHODS Patients younger than 20 years diagnosed with incident cancer during 2012-2017 in the Kentucky Cancer Registry (KCR) were linked with patients enrolled in a Children's Oncology Group (COG) study. Matched patients between databases were described by sex, age, race and ethnicity, geographical location when diagnosed, and cancer type. Logistic regression modeling identified factors associated with COG study enrollment. Timeliness of patient identification by KCR was reported through the Centers for Disease Control and Prevention's Early Case Capture (ECC) program. RESULTS Of 1,357 patients reported to KCR, 47% were determined by matching to be enrolled in a COG study. Patients had greater odds of enrollment if they were age 0-4 years ( v 15-19 years), reported from a COG-affiliated institution, and had renal cancer, neuroblastoma, or leukemia. Patients had lower odds of enrollment if Hispanic ( v non-Hispanic White) or had epithelial (eg, thyroid, melanoma) cancer. Most (59%) patients were reported to KCR within 10 days of pathologic diagnosis. CONCLUSION Linkage of clinical trial data with cancer registries is a feasible approach for tracking patient referral and clinical trial enrollment patterns. Adolescents had lower enrollment compared with younger age groups, independent of cancer type. Population-based early case capture could guide interventions designed to increase cancer clinical trial enrollment.

BACKGROUND:Sociodemographic and clinical factors associated with diagnostic delays in pediatric, adolescent, and young adult cancers are poorly understood. METHODS:Using the Optum Labs Data Warehouse's de-identified claims data for commercial health plan enrollees, we identified children (0-14 years) and adolescents/young adults (AYAs) (15-39 years) diagnosed with one of 10 common cancers from 2001 to 2017, who were continuously enrolled for 6 months preceding diagnosis. Time to diagnosis was calculated as days between first medical encounter with possible cancer symptoms and cancer diagnosis date. Median times from first symptom to diagnosis were compared using Wilcoxon rank sum test. Multivariable unconditional logistic regression identified sociodemographic factors associated with longer time (>3 months) to cancer diagnosis (from symptom onset). RESULTS:Of 47,296 patients, 87% presented prior to diagnosis with symptoms. Patients with central nervous system (CNS) tumors were most likely to present with symptoms (93%), whereas patients with cervical cancer were least likely (70%). Symptoms varied by malignancy. Of patients with symptoms, thyroid (105 days [range: 50-154]) and cervical (104 days [range: 41-151]) cancer had the longest median time to diagnosis. Females and patients at either end of the age spectrum were more likely to experience diagnosis delays of more than 3 months. CONCLUSION:In a commercially insured population, time to diagnosis varies by cancer type, age, and sex. Further work is needed to understand the patient, provider, and health system-level factors contributing to time from symptom onset to diagnosis, specifically in the very young children and the young adult patient population going forward.

Background Approximately 5% of cancer patients in the United States presented with metastatic bone disease (MBD) at diagnosis. Current study explores the disparities in survival for patients with MBD. Methods Patients with the diagnosis of MBD at presentation for the five most common primary anatomical sites were extracted from Surveillance, Epidemiology, and End Results Census tract-level dataset (2010-2016). Kaplan-Meier and Cox Proportional Hazard models were used to evaluate survival, and prognostic factors for each cohort. Prognostic significance of socioeconomic status (SES) and insurance status were ascertained. Results The five most common anatomical-sites with MBD at presentation included "lung" (n = 59 739), "prostate" (n = 19 732), "breast" (n = 16 244), "renal and urothelium" (n = 7718) and "colon" (n= 3068). Lower SES was an independent risk factor for worse disease-specific survival (DSS) for patients with MBD originating from lung, prostate, breast and colon. Lack of insurance was an independent risk factor for worse DSS for MBD patients with primary tumors in lung and breast. Conclusions MBD patients from the five most common primary sites demonstrated SES and insurance-related disparities in disease-specific survival. This is the first and largest study to explore SES and insurance-related disparities among patients specifically afflicted with MBD. Our findings highlight vulnerability of patients with MBD across multiple primary sites to financial toxicity.

151 Background: Availability of guideline-endorsed, cancer-related resources for adolescents and young adults (AYAs: aged 15–39) with cancer is unknown. AYAs often receive treatment in community settings. We describe the current landscape of comprehensive cancer care resources for AYAs treated in community settings. Methods: NCI Community Oncology Research Program (NCORP) practice groups completed the Landscape Assessment in 2022 to describe available infrastructure, resources, and research capacity. Practice groups were included in this analysis if ≥10% of their annual cancer cases were within the AYA age range, or at least 50 AYA cancer cases are treated annually. We described the proportion of practices serving AYA patients with access to fertility preservation, mental health services, genetic testing and counseling, nutritional counseling, distress monitoring (psychosocial and financial), palliative care, and survivorship programs. Results: Of 271 responding practice groups, 77 (28%) met criteria for treating AYAs, whereas 102 (38%) did not meet criteria. The remaining 92 (34%) could not be classified due to missing data. Among the 77 practices treating AYAs, fertility preservation was available at 51% (oocyte cryopreservation) and 58% (sperm banking) of practices. While nutritional support and genetic testing were widely available (99% and 100% respectively), only 49% of practices treating AYAs offered survivorship programs (Table 1). Conclusions: Many AYAs receiving treatment in community settings lack access to key resources for cancer care, including fertility preservation and survivorship services. Future research should seek to identify barriers and facilitators to offering comprehensive resources in NCORP practices that serve AYAs and to advance understanding of AYA uptake of available resources.[Table: see text]

ObjectiveThis study aimed to identify demographic characteristics of test participants and changes in testing participation over time in a community pandemic-response program launched in a college town in California, USA.MethodsWe described overall testing participation, identified demographic characteristics of frequent testers, and evaluated changes in testing participation over four different periods of the COVID-19 pandemic.ResultsA total of 770,165 tests were performed between November 18, 2020, and June 30, 2022, among 89,924 residents of Yolo County (41.1% of population), with significant participation from racially/ethnically diverse participants and across age groups. Most positive cases (49.9%) were captured during Omicron, which also corresponds to the period with the highest daily participation (895 per 100K population). The proportion of participants which we considered “frequent testers” (28.9% vs. 39.7%,p <0.0001) and individuals that tested once (39.5% vs. 47.9%,p <0.0001) increased significantly from Delta to Omicron. Women (58.8%), participants of age 19-34 years (38.8%), and White (53.2%) tested more frequently throughout the program. The proportion of tests conducted among Latinos remained steady around 18% over time, with the exception of the post-Omicron period (13%).ConclusionThe unique features of a pandemic response program that supported communitywide access to free asymptomatic testing provides a unique opportunity to evaluate adherence to testing recommendations, and testing trends over time. Identification of individual and group-level factors associated with testing behaviors is essential to improve access and protect communities at-large.

The National Center for Advancing Translational Sciences (NCATS) has defined translation as the process of turning observations into interventions that are adopted, sustained, and improve health. Translation must attend to research and community systems and context at multiple levels, and to key stakeholders. Dissemination and implementation (D&I) sciences are informed by an understanding of the critical role of people and systems in disseminating, adopting, and sustaining innovations within real-world settings. Thus, the D&I sciences provides a set of principles that can guide the translational work of Clinical and Translational Science Award (CTSA) programs from basic research to public health. In this special communication, our cross-domain working group of the CTSA consortium, comprised of experts in methods and processes, workforce development, evaluation, stakeholder engagement, and D&I sciences, share a vision of how CTSAs can enhance translation across the translational spectrum through the integration of D&I sciences into the critical areas of methods and processes, workforce development, and evaluation. We propose a set of recommendations for NCATS national and local leaders that are intended to move D&I sciences out of a position of unfamiliarity and ancillary value and into the core identity of who CTSAs are, how they think, and what they do, to advance translation and health.

Few studies have explored interventions to improve adolescent and young adult (AYA) cancer care delivery. While many AYAs receive cancer care at NCI Community Oncology Research Program (NCORP) sites, few enroll on clinical trials. Barriers and facilitators to pediatric oncologist activation of and enrollment on an AYA cross-network National Clinical Trials Network (NCTN) supportive care trial were assessed using a survey that was administered to 162 stakeholders representing all 47 children's oncology group (COG) institutions affiliated to an NCORP. Fifty-eight stakeholders participated representing 62% of all sites surveyed. Approximately half of participants (45%) were unaware of the trial. Seven sites had the study open and one enrolled a patient. Reasons for not opening and enrolling on the trial included limited research staff and resources, low anticipated accrual, and lower prioritization of the trial. Enrollment facilitators included having a local "AYA champion," improving communication between pediatric and medical oncology, and having site education on available AYA trials. Interventions focused on increasing site and provider awareness of AYA trials and decreasing local barriers to AYA enrollment are needed.

INTRODUCTION:Advances in diagnostic and treatment modalities for high grade bone sarcomas (HGBS) of lower extremity (LE) have enabled limb salvage resections as a feasible first-line surgical option. However, amputations are still performed. Impact of amputation on survival and predictive factors for amputation and the stage at presentation for HGBS of LE remain unknown.METHODS:National Cancer Database was used to extract 5781 cases of high-grade bone sarcoma of the LE from 2004 to 2017. Kaplan-Meier and Cox regression were used to determine the impact of amputation on survival. Chi square test and logistic regression were used to assess the correlation of predictive factors with amputation and stage at presentation.RESULTS:Amputation [hazard ratio (HR) 1.516; 95% confidence interval (CI) 1.259-1.826; p < 0.001] and advanced stage (HR 0.248; 95% CI 0.176-0.351; p < 0.001) were independent predictors of poor overall survival. The impact of amputation on survival was most pronounced for pediatric and adolescents and young adults (AYA) age groups (18% decrease in 10-year survival). Amputation was more likely to be performed among those with nonprivate insurance (HR 1.736; 95% CI 1.191-2.531; p = 0.004), a finding that was mirrored for advanced stage at presentation (HR 0.611; 95% CI 0.414-0.902; p = 0.013).DISCUSSION:Amputation is an independent predictor of poor outcomes among patients with HGBS of LE. The impact of amputation on survival is the highest for the pediatric and AYA age group. Nonprivate insurance is associated with increased likelihood of amputation and an advanced stage at presentation among patients with high-grade bone sarcoma of the LE. This is the largest study highlighting insurance-related disparities in this cohort.

Background Adolescent and young adult (AYA) cancer survivors experience psychological distress often because of cancer and its treatment. However, no prior studies have evaluated the additional medical expenditures and health care utilization associated with psychological distress in AYA cancer survivors. Methods AYA cancer survivors and a comparison matched group of adults with no history of cancer were identified from 2011-2016 Medical Expenditure Panel Survey data. Medical expenditures and health care utilization were evaluated with multivariable regression models. Results AYA cancer survivors were more likely to have psychological distress (11.5% of 1757) than adults with no history of cancer (5.8% of 5227). The prevalence of psychological distress was found to be high many years after the diagnosis, with 11.2% reporting distress >= 20 years after their cancer diagnosis. AYA cancer survivors with psychological distress were more likely to smoke and have chronic conditions and were less likely to exercise regularly in comparison with AYAs with no history of psychological distress. AYA cancer survivors with psychological distress had additional annual medical expenses ($4415; 95% CI, $993-$9690), office visits (2.80; 95% CI, 0.23-6.15), and use of prescription medications/medication renewals (11.58; 95% CI, 5.70-19.47) in comparison with AYA cancer survivors without psychological distress. Additional annual medical expenses of psychological distress were $2600 higher in AYA cancer survivors than adults without a history of cancer ($1802; 95% CI, $440-$3791). Conclusions These results highlight the substantial economic burden associated with psychological distress in AYA cancer survivors. This research could inform survivorship care plans and interventions addressing the psychological needs of AYA cancer survivors.

Despite efforts to increase participation of adolescents and young adults (AYAs; 15–39 years) in cancer clinical trials (CTs), enrollment remains very low. Even when provided access to CTs, AYAs are less likely to participate than children and older adults. A better understanding of oncologist‐ and AYA survivor‐reported barriers, facilitators, and potential areas for CT enrollment improvement is needed.

Implementation science (IS) has garnered attention within oncology, and most prior IS work has focused on adult, not pediatric, oncology. This narrative review broadly characterizes IS for pediatric oncology. It includes studies through 2020 using the following search terms in PubMed, Ovid Medline, and Cochrane: “implementation science,” “pediatric,” “childhood,” “cancer,” and “oncology.” Systematic review was not performed due to the limited number of heterogeneous studies. Of 216 articles initially reviewed, nine were selected as specific to IS and pediatric oncology. All nine examined oncologic supportive care, cancer prevention, or cancer control. The supportive care focus is potentially due to the presence of cooperative study groups such as the Children's Oncology Group, which efficiently drive cancer‐directed therapy changes through clinical trials. Future IS within pediatric oncology should embrace this ecosystem and focus on cancer control interventions that benefit patients across multiple cancer types and patients treated outside cooperative group studies.

The copyright holder was corrected in the original online version of this article.

As the response to the HIV epidemic in sub-Saharan Africa continues to mature, a growing number of people living with HIV (PLHIV) are aging and risk for non-communicable diseases increases. Routine laboratory tests of serum creatinine have been conducted to assess HIV treatment (ART) suitability. Here we utilize those measures to assess kidney function impairment among those initiating ART. Identification of non-communicable disease (NCD) risks among those in HIV care creates opportunity to improve public health through care referral and/or NCD/HIV care integration. We estimated glomerular filtration rates (eGFR) using routinely collected serum creatinine measures among a cohort of PLHIV with an HIV care visit at one of 113 Centre for Infectious Disease Research Zambia (CIDRZ) supported sites between January 1, 2011 and December 31, 2017, across seven of the ten provinces in Zambia. We used mixed-effect Poisson regression to assess predictors of eGFR <60ml/min/1.73m2 allowing random effects at the individual and facility level. Additionally, we assessed agreement between four eGFR formulae with unadjusted CKD-EPI as a standard using Scott/Fleiss method across five categories of kidney function. A total of 72,933 observations among 68,534 individuals met the inclusion criteria for analysis. Of the 68,534, the majority were female 41,042 (59.8%), the median age was 34 (interquartile range [IQR]: 28–40), and median CD4 cell count was 292 (IQR: 162–435). The proportion of individuals with an eGFR <60ml/min/1.73m2 was 6.9% (95% CI: 6.7–7.1%) according to the unadjusted CKD-EPI equation. There was variation in agreement across eGFR formulas considered compared to unadjusted CKD-EPI (χ2 p-value <0.001). Estimated GFR less than 60ml/min/1.73m2, per the unadjusted CKD-EPI equation, was significantly associated with age, sex, body mass index, and blood pressure. Using routine serum creatinine measures, we identified a significant proportion of individuals with eGFR indicating moderate or great kidney function impairment among PLHIV initiating ART in Zambia. It is possible that differentiated service delivery models could be developed to address this subset of those in HIV care with increased risk of chronic kidney disease.

PURPOSE:The ideal local treatment modality for pelvic and sacral Ewing sarcoma (EWS) is controversial. METHODS:We present the data from the American College of Surgeon's National Cancer Database (NCDB) and the National Cancer Institute's Surveillance, Epidemiology and End Result (SEER) database to investigate the impact of local treatment modalities on survival for nonmetastatic pelvic and sacral Ewing sarcoma. Local treatment includes "surgery," "radiation," and a combination of "surgery and radiation." RESULTS:A total of 235 cases from SEER and 285 cases from NCDB were analyzed. Patients with "localized" stage (intraosseous) in the SEER database did not show any statistically significant difference in the disease-specific survival (DSS) for any of the local treatment modalities. Similar findings were observed for overall survival among patients with American Joint Committee on Cancer (AJCC) stage II and III in the NCDB database. However, patients with nonmetastatic disease, particularly regional disease (extraosseous), showed improved DSS with surgery only, in the SEER. CONCLUSION:We found similar levels of efficacy for different treatment modalities for patients with intraosseous and AJCC II and III pelvic and sacral EWS. "Radiotherapy" is the most common local treatment modality employed in the United States. A prospective, randomized controlled trial with a direct head-to-head comparison is needed for a definitive conclusion.

Background Adolescent and young adult (AYA) patients with cancer are underrepresented on cancer clinical trials (CCTs), and most AYAs are treated in the community setting. Past research has focused on individual academic institutions, but factors impacting enrollment vary across institutions. Therefore, we examined the patterns of barriers and facilitators between high- and low-AYA enrolling community-based clinics to identify targets for intervention. Materials and Methods We conducted 34 semi-structured interviews with stakeholders employed used at National Cancer Institute Community Oncology Research Program (NCORP) affiliate sites ("clinics"). Stakeholders (eg, clinical research associates, patient advocates) were recruited from high- and low-AYA enrolling clinics. We conducted a content analysis and calculated the percentage of stakeholders from each clinic type that reported the barrier or facilitator. A 10% gap between high- and low-enrollers was considered the threshold for differences. Results Both high- and low-enrollers highlighted insufficient resources as a barrier and the presence of a patient eligibility screening process as a facilitator to AYA enrollment. High-enrolling clinics reported physician gatekeeping as a barrier and the improvement of departmental collaboration as a facilitator. Low-enrollers reported AYAs' uncertainty regarding the CCT process as a barrier and the need for increased physician endorsement of CCTs as a facilitator. Conclusions High-enrolling clinics reported more barriers downstream in the enrollment process, such as physician gatekeeping. In contrast, low-enrolling clinics struggled with the earlier steps in the CCT enrollment process, such as identifying eligible trials. These findings highlight the need for multi-level, tailored interventions rather than a "one-size-fits-all" approach to improve AYA enrollment in the community setting.