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In April 2021, the National Cancer Institute (NCI) Division of Cancer Prevention collaborated with the NCI Division of Cancer Treatment and Diagnosis to produce a virtual workshop that developed recommendations for enhancing NCI-sponsored clinical trial accrual of older adults. Prior to the workshop, a multidisciplinary group of stakeholders (eg, community oncologists, advanced practice practitioners, clinic and research staff, and patient advocates) gathered information related to accrual of older adults to clinical trials from the literature. Subsequently, a survey was conducted to detail NCI Community Oncology Research Program members’ perspective on accrual barriers for this population; 305 individuals responded to the survey. Barriers to clinical trial accruals included comorbidity-attributed trial ineligibility, transportation and time issues, concern that the proposed regimen is too toxic for older adults, patient or family caregiver declined participation, and lack of trials relevant to older patients. Identified solutions included broadening clinical trial inclusion criteria, increasing the number of clinical trials specifically designed for older adults, simplifying consent forms, improving recruitment materials for older adults and their families, and facilitating transportation vouchers. At the workshop, participants, including stakeholders, used prior literature and survey results to develop recommendations, including interventions to address clinician bias, implement geriatric assessment, and promote clinician and staff engagement as mechanisms to improve accrual of older adults to clinical trials.

Background To the authors' knowledge, the empiric identification of agents and interventions to mitigate chemotherapy-induced peripheral neuropathy (CIPN) has resulted in only 1 agent that modestly mitigates it and no agents or interventions that prevent its development. This speaks to the need for a mechanistic understanding of CIPN to develop effective interventions. Methods To understand the extent to which mechanistic understanding of CIPN is being translated into the development of interventions, the National Cancer Institute conducted a review of the National Institutes of Health (NIH)'s portfolio of investigator-initiated grants, the literature regarding CIPN mechanisms, and the clinical trials listed in the ClinicalTrials.gov database from January 1, 2011, to May 22, 2019. Results A total of 69 NIH-supported grants and 95 published articles were identified that evaluated mechanistic pathways of 7 different chemotherapy agents that cause CIPN. The review also identified 35 clinical trials that investigated agents or devices with which to treat CIPN. Only 3 trials incorporated a mechanistic rationale to support the choice of the intervention. Conclusions To the authors' knowledge, very little of the mechanistic understanding of the development of CIPN is being translated into intervention rationale in clinical trials that evaluate interventions to mitigate CIPN. Efforts to incentivize this translation are needed.

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.

Background/Purpose: Clinical trials offer an underutilized platform to address health disparities. Most disparities-related work in clinical trials has focused on improving patient diversity, rather than on the research questions to reduce disparities. Within the NCI Community Oncology Research Program (NCORP), a large community-based clinical trials network, cancer disparities research incorporates the needs of diverse populations across its scientific portfolio of cancer control, symptom science, prevention, and care delivery studies. The objective of this portfolio analysis was to pilot a process to identify disparities-focused studies and related research gaps. Methods: We identified NCORP studies approved between August 2014-April 2021 with a focus on NIH health disparity and NCORP populations of interest (e.g., racial/ethnic minorities, rural residents, older adults, adolescent/young adults). After screening study titles and aims, studies were included if they focused exclusively on cancer disparities (primary aim) or had a disparities-related aim in studies with a broader focus (secondary aim). Coders abstracted study protocols across NCORP research areas, study-, cancer- and disparities-related characteristics. Coding disagreements were discussed until agreement. Descriptive statistics are reported. Results: The search identified 101 NCORP approved studies, of which 31% (n=31) were deemed disparities-focused. Most disparities-focused studies had primary disparities aims (n=26); fewer had secondary disparities aims (n=5). Sixty-five percent focused on populations underrepresented in clinical trials (9 older adults, 8 AYAs, and 3 other underserved), and 35% focused on health disparity populations (7 racial/ethnic minorities, 2 rural, and 2 socioeconomically disadvantaged). Most studies were available to English-speaking patients only (n=17), with Spanish the most common language accommodation (n=9). By NCORP scientific scope, 20 studies assessed patients’ quality of life, cancer-related or treatment-related symptoms; fewer addressed care delivery (n=8), prevention (n=1), or other topics (n=2). The most common outcome was adverse events or toxicity (n=6) and studies mostly included patients in active (n=19) versus post-treatment (n=10). Study designs were observational (n=15) or interventional (n=16) and examined individual (n=14), interpersonal (n=15) or multiple domains of influence (n=2). Conclusion: Through this pilot we defined a process to identify and describe NCORP disparities focused research and assessed related gaps. Over 30% of studies in the pilot had a primary disparities aim and focused on several populations of interest. Preliminary recommendations based on this pilot include strategies to increase secondary disparities approaches, disparities focused cancer prevention and care delivery research, studies examining multiple domains of influence, and expansion of language availability. NCORP’s strong infrastructure will build on this work to enhance the portfolio of disparities research in the community setting. Citation Format: Brenda A. Adjei, Manami Bhattacharya, Diane St. Germain, Alexis Bakos, Worta McCaskill-Stevens. Identifying cancer disparities research gaps in NCORP: A pilot portfolio analysis [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B120.

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.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.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.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.

Objective The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies. Materials and Methods Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission. Results Data were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term. Discussion Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting. Conclusions Patient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.

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.

Objectives To describe the evolution and structure of the National Cancer Institute clinical trials programs, their notable accomplishments, nurses’ roles in these accomplishments, and the essential role of nursing today and in the future. Data Sources Manuscripts, government publications, websites, and professional communications. Conclusion Change is inevitable and a constant factor in the world of advancing science and clinical research. Nurses’ contribution to research and evidence-based practice will continue to grow and is vital as the scientific landscape evolves. Implications for Nursing Practice As the understanding of cancer biology increases and clinical trials evolve, nurses will need to remain key team members and leaders in National Cancer Institute Community Oncology Research Program and National Cancer Trials Network trials and their associated infrastructure.

Cancer clinical trials offer patients an opportunity to receive new and innovative treatment, as well as contribute to the future of cancer care. Enrollment onto clinical trials also may lead to better care and outcomes; however, few adult patients with cancer and even fewer ethnic and racial minority patients participate.

Although recent scientific advances have improved our understanding of basic biological mechanisms underlying chemotherapy-induced peripheral neuropathy (CIPN), few interventions are available to prevent or treat CIPN. Although some biological targets from preclinical studies show promise in nonhuman animal models, few targets have been translated to successful clinical trials. To address this problem, the National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee convened a meeting of experts in the CIPN and oncology symptom management fields to participate in a Clinical Trials Planning Meeting (CTPM). Investigators presented data from preclinical and translational studies for possible CIPN interventions; these were evaluated for readiness of randomized clinical trial testing by experts, and recommendations were provided. Breakout sessions were convened to discuss and develop future studies. The CTPM experts concluded that there is compelling evidence to move forward with selected pharmacological and nonpharmacological clinical trials for the prevention and treatment of CIPN. Several key feasibility issues need to be addressed, however. These include identification of optimal outcome measures to define the CIPN phenotype, establishment of parameters that guide the evaluation of clinically meaningful effects, and adoption of approaches for inclusion of translational and biomarker and/or genetic measures. The results of the CTPM provide support for conducting clinical trials that include both pharmacological and nonpharmacological approaches, alone or in combination, with biomarkers, genetics, or other measures designed to inform underlying CIPN mechanisms. Several working groups were formed to design rigorous CIPN clinical trials, the results of which are ongoing.

Background Cancer frequently occurs with other chronic diseases, and this poses serious care coordination challenges during patients’ active cancer treatment (ACT) and contributes to disparities in health outcomes. There is limited research addressing pre-existing chronic comorbidity (PCC) management during ACT. This study aimed to examine oncologists’ approach for PCC management during ACT. Methods Oncologists in the National Cancer Institute’s Community Oncology Research Program (NCORP) were surveyed about their approach in managing PCC. The Likert scale survey was piloted-tested, IRB-approved, and administered to oncologists. In December 2018, NCORP network oncologists were sent an email invitation to complete the online survey. Pearson chi-square test was used to identify differences in oncologists’ management approach of PCC. Results Among the 375 respondents of the ongoing survey, 45.6% practiced primarily as medical oncologists, 37.3% as hematology, surgical, or radiation oncologists, and 17.1% as other oncology specialists. Approximately 70% of oncologists reported that >50% of their patients had ≥ 1 PCC. When asked about the three most challenging PCC to manage, 23.3% cited diabetes, 19.5% cited heart disease, and 57.1% cited another PCC. Medical oncologists were more likely to cite diabetes first (77.5%) and less likely (22.5%) to cite heart disease first compared to other specialists (p=0.004). Co-management with patients’ PCP was the most common management approach for diabetes among medical oncologists (42.2%) compared to those of other specialties (15.0%) while referral to other physicians was the most common approach among those of other specialties (50.0%) compared to medical oncologists (22.5%) (p=0.002). Consultation and referral were the most common management approaches for heart disease across oncology specialties. Conclusion Oncologists face significant challenges to manage patients’ PCC during ACT. These results indicate that the medical oncologist is more likely to co-manage diabetes with patients’ PCP compared to other oncology specialists, but heart disease was seldom co-managed. Greater collaboration between oncology and non-oncology specialists is needed for effective management of PCC during ACT to ensure complete and coordinated care and to reduce disparities in health outcomes for these patients. Citation Format: Dudith Pierre-Victor, Iman K. Martin, Brenda Adjei, Mary Shaw-Ridley, Bruce Rapkin, Marjorie Good, Diane ST. Germain, Bernard Parker, Worta McCaskill-Stevens. Oncologists’ approach in managing pre-existing chronic comorbidities during patients’ active cancer treatment [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D079.

Background The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). Objective The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. Methods Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. Results Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). Conclusions Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. Trial registration ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl).

BACKGROUND The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). OBJECTIVE The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. METHODS Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. RESULTS Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). CONCLUSIONS Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl)

Early-phase cancer trials are designed to evaluate the safety, tolerability, and preliminary efficacy signals of a new therapeutic agent or combination. In a phase 1 trial the maximal tolerated dose is determined based on clinician assessment of toxicity during the first cycle of treatment. However, this may not always reflect the patient’s experience of tolerability over time. With more anticancer agents receiving accelerated approval based on early-phase trial data, and an expanding array of orally administered agents, the need to incorporate the patient’s perspective in early-phase trials has become more essential. The value of patient-reported outcomes (PROs) in later-phase trials can be extended and modified for the inclusion of PROs in the early drug development. This chapter traces the history of PRO inclusion in clinical trials, highlights selected PRO assessment tools, and outlines the important study design issues to consider when measuring, analyzing, and reporting PROs in early-phase clinical trials.

There are essential elements that need to be in place to conduct a clinical trial successfully. First is a knowledgeable, adequately staffed research team well versed in the conduct of clinical research. Second, a clearly written protocol document that provides the necessary background information, rules and all aspects of conducting the study is needed. It is during the development phase of a protocol that all facets of data collection and management should be established: what, how, when data are collected and by whom. Third, timely and accurate data collection and analysis is crucial as data reveal the trial’s progress, toxicities and determine the outcome of a trial. Lastly, each member of the research team must be knowledgeable of and comply with the legal and regulatory aspects of clinical research. Conducting clinical research is a significant commitment of time, resources, and money; hence it is vital to have these elements in place for the trial to succeed.

Background The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute’s Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period. Methods To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials. Limitations The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish. Conclusion The National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute—American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizational-level approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to implement yet proved valuable as they provided useful metrics for programmatic assessment, planning, reporting, and growth. While focused on oncology trials, these concepts may be useful within other disease-focused research as well.

e14587 Background: Despite the identification of multiple patient, clinician, and health systems barriers, accrual to a new generation of cancer clinical trials continues to present challenges. It may be that barrier data is not sufficiently granular. A clinical trial screening tool was developed for use in NCORP to collect trial- and site-specific information as well as broadened demographic data to determine factors that may impact accrual. Methods: The tool was developed with stakeholder input and the NCI Oncology Patient Enrollment Network was used for data input and analyses. Results: From February 2016 to December 2019, 14,340 entries were made in the screening tool. Eighty-two percent of participants consented to participate. Participants screened were female (77%), married (64%) and Caucasian (85%). Fourteen percent of the participants were racial minorities (1% not reported) and 5% were Hispanic or Latino. The mean age was 60 (range 1-95). Thirty-six percent were employed, ≥ 32 hours per week followed by 35% retirees. Income did not vary significantly ( < $25,000(16%), $25,000 - $50,00 (20%), $51,000 - $10,000 (26%), and > $100,000 (19%), and 19% of participants refused to provide income data. Four percent of the participants were uninsured at diagnosis. Seventy-two percent (8,501) of participants screened enrolled in a clinical trial. Of those not enrolled, 49% were ineligible and 48% were eligible but declined to participate. The most common reasons for ineligibility included concurrent disease, abnormal lab or other tests, and patient could not comply with eligibility criteria. The most common reasons eligible participants declined to participate were perception that toxicities were too great and social issues (child care, transportation). Further analysis of the data will include correlation of race/ethnicity, age, income and co-morbidities with enrollment status. Conclusions: The majority of participants approached agreed to participate in the screening tool protocol. Approximately half of the participants were eligible for a trial but declined to participate. These issues will be addressed within the network to enhance accrual. The data collected will also provide opportunities for investigators within the network to develop research questions focused on disparities and clinical trial accrual.

e18036 Background: Cancer frequently occurs with other chronic diseases, and this poses serious care coordination challenges during patients’ active cancer treatment (ACT). There is limited research addressing chronic comorbidity (CC) management during ACT. This study aimed to examine practicing oncologists’ perceived confidence in independently managing CC during ACT. Methods: Oncologists in the National Cancer Institute’s Community Oncology Research Program (NCORP) were surveyed about their perceived confidence in managing CC. The Likert scale survey was piloted-tested, IRB-approved, and administered to oncologists. In December 2018, NCORP network oncologists were sent an email invitation to complete the online survey. Pearson chi-square test was used to identify oncologists’ differences in perceived confidence in managing CC. Results: Among the 201 respondents of the ongoing survey, 48% were medical oncologists, 21.2% radiation or surgical oncologists, and 30.8% were of other specialties. Overall, 69% agreed (agree or strongly agree), 17.3% were neutral, and 13.4% disagreed (strongly disagree or disagree) that they were confident in managing all CC independently. While 69% of oncologists were confident when managing any CC, only 49% and 19.8% remained confident when managing CC previously managed by a primary care physician (PCP) and by a non-oncology subspecialist, respectively. Across oncologic subspecialties, 47.6%, 77.9% and 72.1% of radiation/surgical oncologists, medical oncologists, and those of other specialties, respectively, agreed that they were confident in independently managing CC (p = 0.003). Conclusions: Most oncologists are confident in managing all CC during patients’ ACT. However, they were less confident with CC previously managed by PCPs, and even less confident for CC previously managed by non-oncology subspecialists. These results indicate opportunities for greater collaboration between oncology and non-oncology specialists to ensure complete and coordinated care for cancer patients with comorbidities.

Overview: Although clinical trials represent a vital opportunity for improvements in cancer treatment, data show that a small proportion of patients with newly diagnosed cancer participate in clinical research. Black patients continue to have a worse prognosis for most cancers compared with other patients of other races/ethnicities. Racial/ethnic- and age-related disparities in clinical trial accrual are also well documented. The recruitment and retention of minorities in these trials present an even greater challenge despite regulatory efforts and initiatives to increase representation. Treatment data from homogenous populations prevent us from understanding therapeutic response and the true safety profile of novel therapies. Patient-, physician-, and system-level factors that affect trial participation have been extensively studied. However, years of accrual data remain largely unchanged, suggesting the challenge lies in effectively addressing these factors. Furthermore, data showing that black patients tend to have more advanced stage cancers at the time of diagnosis in fact beg their overrepresentation on clinical trials. An inability to successfully enroll diverse populations in clinical trials only exacerbates racial/ethnic differences in cancer treatment and survivorship.

220 Background: With the rising number of survivors across many cancer sites, increasing attention is being paid to assessing, preventing, and managing cancer and treatment related symptoms. This presentation will discuss the breadth of the symptom management portfolio within the community research programs funded by the NCI: The Community Clinical Oncology Program (CCOP) and the NCI Community Oncology Research Program (NCORP) from 2008 to 2018. Trends in types of symptoms and study designs will be described to identify research gaps. Methods: Symptom management research was operationally defined as any clinical study focusing on cancer and treatment related symptoms and/or related psychological, social and spiritual problems. The primary endpoint is measured by a patient reported outcome (PRO). Using this definition, a search was conducted of the NCI database to capture clinical studies implemented in the CCOP and NCORP networks from 2008 to 2018. Results: Between 2008 and 2018, 68 clinical studies were conducted in the NCI community research programs that met this definition. During this period of time, the most frequently studied symptom was neurotoxicities (n = 13), comprised of chemotherapy induced peripheral neuropathy (n = 3), neurocognition (n = 9) and ototoxicity (n = 1). Gastrointestinal symptoms (n = 10), pain (n = 9) and fatigue (6) were the following most frequent. The least studied symptoms included genitourinary symptoms (n = 1), vaginal health (n = 1), sexual desire (n = 1), psychosocial (n = 2) and lymphedema (n = 2). The predominant trial design was phase II or III randomized clinical trial with the remaining longitudinal, cohort design. Further delineation of these data will be presented. Conclusions: The prevalence of the symptoms studied within the NCI community programs mirrors the symptom literature in terms of frequency. Cancer survivors have reported a number of symptoms not adequately addressed by their clinicians such as sexual health and psychosocial issues. This gap also mirrors the frequency of research conducted in the community networks. Future research in the network focusing on these understudied areas should be considered by investigators.

In response to a 2005 solicitation from the U.S. National Institutes of Health, 16 investigators received funding to test interventions that would reduce the barriers that prevent cancer patients from receiving adequate and appropriate symptom management therapies. Since the awards have been issued, the investigators have met two times and have identified a number of challenges to implementing their respective studies. A survey was conducted that focused on their experiences with hiring and retaining study personnel, gaining Institutional Review Board approval, incurring unexpected costs, challenges to accruing participants, and a listing of standard measures used in the study. The survey was completed online by the Principal Investigator for each project in late 2006 and the initial results were confirmed one year later by resending the initial survey and by a follow-up telephone call. All but one Principal Investigator completed the survey. Obtaining Institutional Review Board approval, hiring and recruiting research personnel, establishing subcontracts, and accruing research subjects were the primary challenges experienced by the investigators. This palliative care solicitation achieved more than its original intent of stimulating research in overcoming barriers to delivering cancer symptom management, palliative care and end-of-life care. From a survey on the challenges and issues that emerged from their projects, grantees were able to identify specific hurdles and their unique solutions that may help other investigators as they plan their program of research.

QUESTION ASKED: Is there a tool for sites engaged in cancer clinical research to use to assess their infrastructure and improve their research conduct toward exemplary levels of performance beyond the standard of Good Clinical Practice (GCP)? SUMMARY ANSWER: The NCI Community Cancer Center Program (NCCCP) sites, with NCI Clinical Trial advisor input, created a “Clinical Trials Best Practice Matrix” self-assessment tool to assess research infrastructure. The tool identified nine attributes (eg, physician engagement in clinical trials, accrual activity, clinical trial portfolio diversity), each with three progressive levels (I – III) for sites to score infrastructural elements from less (I) to more (III) exemplary. For example, a level-one site might have active Phase III treatment trials in two to three disease sites and review their portfolio diversity once a year, whereas a level-three site has active Phase II and also Phase I or I/II trials across five or more disease sites and reviews their portfolio quarterly. The tool also provided a road map toward more exemplary practices. METHODS: From 2011 to 2013, 21 NCCCP sites self-assessed their programs with the tool annually. Sites reported significant increases in level III (more exemplary) scores across the original nine attributes combined (P < .001 [see Figure 1 ]). During 2013 to 2014, NCI collaborators conducted a five-step formative evaluation of the tool resulting in expansion of attributes from nine to 11 and a new name: the Clinical Trials Assessment of Infrastructure Matrix, or CT AIM, tool which is described and fully presented in the manuscript. BIAS, CONFOUNDING FACTOR(S), DRAWBACKS: Tool scores are self-reported which are subject to potential bias. The tool was developed by community hospital based cancer centers and has not been psychometrically validated. Use of scores for ranking between programs is not recommended at this time. The attributes and indicators in the tool may need to be adapted for other settings (eg, academic or private practice settings), and over time as research practice evolves. Not all sites can, or want to, move beyond the provision of GCP in their research programs. Adherence to GCPs meets the minimum criteria for clinical trial conduct and some of the attributes in the CT AIM can be both fiscally and administratively challenging to implement. REAL-LIFE IMPLICATIONS: The CT AIM tool gives community programs a tool to assess their research infrastructure as they strive to move beyond the basics of GCP to more exemplary performance. Experience within the NCCCP program suggests the CT AIM tool may be useful for improving programmatic quality, benchmarking research performance, reporting progress, and communicating program needs with institutional leaders. The tool may also be a companion to existing clinical trial education and program resources. Although used in a small group of community cancer centers, the tool may be adapted as a model in other disease disciplines. [Figure: see text]

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.

Purpose: Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials. Methods: The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility. Results: Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P .15) or between Hispanic and non-Hispanic patients (P .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers. Conclusion: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.

To prospectively compare outcomes and processes of hospital-based early palliative care with standard care in surgical oncology patients (N = 152).A randomized, mixed methods, longitudinal study evaluated the effectiveness of a hospital-based Pain and Palliative Care Service (PPCS). Interviews were conducted presurgically and at follow-up visits up to 1 year. Primary outcome measures included the Gracely Pain Intensity and Unpleasantness Scales and the Symptom Distress Scale. Qualitative interviews assessed social support, satisfaction with care, and communication with providers. Survival analysis methods explored factors related to treatment crossover and study discontinuation. Models for repeated measures within subjects over time explored treatment and covariate effects on patient-reported pain and symptom distress.None of the estimated differences achieved statistical significance; however, for those who remained on study for 12 months, the PPCS group performed better than their standard of care counterparts. Patients identified consistent communication, emotional support, and pain and symptom management as positive contributions delivered by the PPCS.It is unclear whether lower pain perceptions despite greater symptom distress were clinically meaningful; however, when coupled with the patients' perceptions of their increased resources and alternatives for pain control, one begins to see the value of an integrated PPCS.

Background Whereas it is established that organic pain may induce depression, it is unclear whether pain is more common in healthy subjects with depression. We assessed the prevalence of pain in premenopausal women with major depression (MDD). Subjects were 21- to 45-year-old premenopausal women with MDD (N = 70; age: 35.4 +/- 6.6; mean +/- SD) and healthy matched controls (N = 36; age 35.4 +/- 6.4) participating in a study of bone turnover, the P.O.W.E.R. (P remenopausal, O steopenia/Osteoporosis, W omen, Ale ndronate, Depr ession) Study. Methods Patients received a clinical assessment by a pain specialist, which included the administration of two standardized forms for pain, the Brief Pain Inventory – Short Form, and the Initial Pain Assessment Tool, and two scales of everyday stressors, the Hassles and Uplifts Scales. In addition, a quality-of-life instrument, the SF-36, was used. The diagnosis of MDD was established by a semi-structured interview, according to the DSM-IV criteria. Substance P (SP) and calcitonin-gene-related-peptide (CGRP), neuropeptides which are known mediators of pain, were measured every hour for 24 h in a subgroup of patients (N = 17) and controls (N = 14). Results Approximately one-half of the women with depression reported pain of mild intensity. Pain intensity was significantly correlated with the severity of depression (r2 = 0.076; P = 0.04) and tended to be correlated with the severity of anxiety, (r2 = 0.065; P = 0.07), and the number of depressive episodes (r2 = 0.072; P = 0.09). Women with MDD complained of fatigue, insomnia, and memory problems and experienced everyday negative stressors more frequently than controls. Quality of life was decreased in women with depression, as indicated by lower scores in the emotional and social well-being domains of the SF-36. SP (P < 0.0003) and CGRP (P < 0.0001) were higher in depressed subjects. Conclusion Women with depression experienced pain more frequently than controls, had a lower quality of life, and complained more of daily stressors. Assessment of pain may be important in the clinical evaluation of women with MDD. SP and CGRP may be useful biological markers in women with MDD.

230 Background: Many community cancer research programs aim to exceed Good Clinical Practices. To support such efforts, the National Cancer Institute and collaborators began developing the Clinical Trials Assessment of Infrastructure Matrix (CT AIM) Tool in 2008. CT AIM’s 3 levels of exemplary performance span 11 infrastructure attributes. 2013’s revisions focused on interpretability, usability, and measurability. Methods: Tool input was obtained at national research meetings. Also, 4 Principal Investigator-Program Administrator (PI/PA) pairs from NCI-funded community cancer programs with varied demographics (eg, size, population) underwent cognitive interviews. Aggregated responses and a major-themes summary led to tool revisions. Next a web-based version was piloted with 4 more PI/PA pairs. The frequency/distribution of responses within pairs was assessed. The revised tool was then field-tested with 9 more PIs and scoring method feedback was collected; the tool was further revised. Results: Per community input and cognitive interviews: (1) “best practice” designation was replaced with “assessment of infrastructure”, (2) attributes were reordered based on perceived importance, (3) terms and cumulativeness of levels were clarified. Receiving 0 “don’t understand”s indicated improvement in clarity. 64% of “don’t know” responses were from respondents at the same program and 5 were from the biospecimen research attribute, indicating the information is difficult for programs to obtain. PI/PA responses varied 36% of the time, of which 70% involved a 1-level difference in response, indicating variation in responses by program role. 2 questions generated inconsistent responses from all 4 pairs, indicating possible further revisions. Average scoring was more accurate and sensitive to incremental program improvements. Conclusions: Broad community input, cognitive interviews, and piloting improved the tool’s clarity. Program leaders are encouraged to use CT AIM with research team members to enhance site infrastructure. CT AIM is useful for quality improvement, benchmarking research performance, progress reporting, and communicating program needs with institutional leaders. NCI Contract No. HHSN261200800001E

6512 Background: ASCO described minimum standards and exemplary attributes for CT sites to improve research quality (Zon et al JCO 2008, JOP 2011; Baer et al JOP 2010). Based on these attributes, the NCI Community Cancer Centers Program (NCCCP) developed and piloted the CT AIM Tool to facilitate research program improvements through self-assessment and benchmarking. The tool identified 9 attributes (see Table) each with 3 progressive levels for research sites to “score” their program from less (Level 1) to more (Level 3) exemplary CT infrastructure (e.g. Level 1- only phase 3 treatment trials open vs. Level 3 – Phase 1/2/3, cancer control and prevention trials open). Methods: From 2011-13, 21 NCCCP sites self assessed their CT programs annually using the tool. Results: See Table. Conclusions: Statistically significant increases (p < 0.0001) occurred in Level 3 (more exemplary) infrastructure ratings from 2011 to 2013 across all 9 attribute categories assessed at the 21 sites. Statistically significant gai...

e17560 Background: Use of electronic Patient-Reported Outcomes (ePROs) are increasingly employed in patient care and oncology research. However, these systems can be difficult to use, preventing adoption and deployment. The objective is to evaluate the patient usability of the National Cancer Institute’s (NCI) Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System. Methods: PRO-CTCAE is an item bank of 124 questions evaluating 78 symptomatic adverse events, as well as a software system that includes a web-based and interactive voice response system [IVRS] to administer these items to patients, and electronic features to customize survey creation, schedule survey administration, export data, and generate alerts and reports. A protocol was developed for two rounds of usability testing to evaluate understanding and ease of navigation reported by patients undergoing cancer treatment. Software was refined between rounds and retested. Patients were asked to login and complete PRO-CTCAE items either in clinic or at home, then were immediately debriefed (semi-scripted) by a trained interviewer. Results: 173 patients at 3 cancer centers and affiliated community network sites were enrolled in the study between 1/11-5/12 (45% male; 32% non-white; 26% high school or less). Usability issues identified in Round 1 (N=37) included difficulty in using radio buttons, absence of survey progress indicators, and problems with system login. Modifications included increasing size of buttons, improving the progress bar feature, and simplifying the interface to focus users on survey questions. In Round 2 (N=136), remaining issues were related to general difficulty with Internet use, such as navigating to the URL. IVRS testing indicated high scores of ease of use and completion of items, but users had difficulty adding unique symptoms to the system. Conclusions: Iterative usability testing identified improvements to web-based and IVRS for patient self-reporting and achieved a more favorable user experience. The feasibility of integrating PRO-CTCAE into trials to gather symptomatic adverse events directly from patients is currently being evaluated in the cancer cooperative groups.

6086 Background: In 2007, NCI launched the NCCCP, a public-private partnership with 16 community hospital cancer centers in 14 states, to explore methods to improve patient access to advanced cancer care in the community. With 40% of its NCI funding directed to reduce disparities across the cancer continuum, the NCCCP aims to: 1) Enhance access to care; 2) Improve quality of care; and 3) Increase clinical trials accrual. This approach supports priorities in the 2009 ASCO Policy Statement: Disparities in Cancer Care. Methods: A disparities workplan was developed to support the three aims. NCI and the sites worked as a learning collaborative to develop strategies and metrics for: race and ethnicity data tracking; near real-time reporting of adherence to Commission on Cancer (CoC) treatment quality measures; community outreach and patient navigation to increase cancer screening; and improved clinical trial underserved accrual. The tools and resources supporting these efforts will be discussed. ( http://ncccp.cancer.gov/About/Progress.htm ). Results: Evaluation of the 3 year pilot shows improvement for underserved populations: Concordance with CoC treatment quality measures for radiation therapy for breast conserving surgery among Medicaid patients improved from 59.5 percent to 84.8 percent (p