Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients.

NCCN guidelines indicate that cancer clinical trials (CCTs) are the best management for patients with cancer. However, only 5% of patients enroll in them. We examined oncologists' perceived barriers and facilitators to discussing CCTs. This qualitative study was part of the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. Barriers and facilitators at the system, trial, provider, and patient levels were examined. To achieve triangulation, patient encounters were reviewed using chart-stimulated recall (CSR) methods, thereby obtaining a valid assessment of physician performance. Ten oncology providers participated in this study. Nine were oncologists, and one was a clinical research coordinator; five were female; four were White; three were Asian; and three were Black. Barriers to offering CCTs were a lack of trial availability; ineligibility; a lack of knowledge; assumptions about patient interest, benefits, or harms; patient's disease factors; and negative attitudes. Facilitators of offering CCTs were a physical space to discuss trials; greater trial availability; a systematic approach to offering trials; patient factors; patients seeking trials; a lack of comorbidities; patients being younger in age; patients being aware of, asking about, or hearing of trials from their surgeon; and higher levels of altruism. Many of the cited barriers are addressable with the cited facilitators. A larger study is needed to generalize and validate these findings.

Barriers to Clinical Trial Implementation Among Community Care Centers.

Importance: While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol. Objective: To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment. Design, Setting, and Participants: This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)-ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents. To determine participation trends among health care practices in oncology-focused research, identify barriers to clinical trial implementation and operation, and establish unmet needs for cancer clinics interested in trial participation, a 34-question survey was designed. Survey questions were defined within 3 categories: cancer center demographic characteristics, clinical trial characteristics, and referral practices. The survey was distributed through email and was open from June 20 through October 5, 2022. Main Outcomes and Measures: Participation in and barriers to conducting oncology trials in different community oncology settings. Results: The survey was distributed to 100 cancer centers, with completion by 58 centers (58%) across 25 states. Fifty-two centers (88%) reported that they conduct therapeutic clinical trials, of which 33 (63%) were from urban settings, 11 (21%) were from suburban settings, and 8 (15%) were from rural settings. Only 25% of rural practices (2 of 8) offered phase 1 trials, compared with 67% of urban practices (22 of 33) (P = .01). Respondents noted challenges in conducting research, including patient recruitment (27 respondents [52%]), limited staffing (27 [52%]), and nonrelevant trials for their patient population (25 [48%]). Among sites not offering therapeutic trials, barriers to research conduct included limited infrastructure, funding, and staffing. Most centers (46 of 58 [79%]) referred patients to outside centers for clinical trial enrollment, particularly in the context of late-stage disease and/or disease progression. Only 17 of these sites (37%) had established protocols for patient follow-up subsequent to outside referral. Conclusions and Relevance: In this national survey study of barriers to clinical trial implementation, most sites offered therapeutic trials, but there were significant disparities in trial availability across care settings. Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities. These results identify crucial unmet needs for oncology clinics to effectively offer clinical trials to patients seeking care.

Healthcare providers' experiences of continuing care for older adults with cancer during the COVID-19 pandemic.

PURPOSE: The COVID-19 pandemic has caused great strain on older adults with cancer and their healthcare providers. This study explored healthcare providers' reported changes in cancer care, clinical barriers to care, patient questions, and the overall experiences of caring for older adults with cancer during the COVID-19 crisis. METHODS: The Advocacy Committee of the Cancer and Aging Research Group and the Association of Community Cancer Centers developed a survey for healthcare providers of adults with cancer, inquiring about their experiences during the pandemic. Responses from the survey's four open-ended items were analyzed by four independent coders for identification of common themes using deductive and inductive methods. RESULTS: Participants (n = 137) represented a variety of demographic and clinical experiences. Six overall themes emerged, including (1) telehealth use, (2) concerns for patient mental health, (3) patient physical and social isolation, (4) patient fear of contracting COVID-19, (5) continued disruptions to cancer care, and (6) patients seeking guidance, particularly regarding COVID-19 vaccination. Questions fielded by providers focused on the COVID-19 vaccination's safety and efficacy during older adults' cancer treatment. CONCLUSIONS: Additional resources (e.g., technology support, established care guidelines, and sufficient staffing) are needed to support older adults with cancer and healthcare providers during the pandemic. Future research should explore universally effective in-person and virtual treatment strategies for older adults with cancer. IMPLICATIONS FOR CANCER SURVIVORS: Persistence of telehealth barriers, particularly a lack of infrastructure to support telehealth visits, social isolation, and restrictive visitor policies as a result of COVID-19, negatively impacted the mental health of older adults with cancer.

Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment.

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials.

PURPOSE: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients. MATERIALS AND METHODS: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them. Discussion focused on (1) specific elements of the training modules; (2) how to apply lessons learned; and (3) key considerations for developing a facilitation guide to support peer-to-peer discussions in cancer clinical research settings. We evaluated discussion via a qualitative assessment. RESULTS: Participant completion rate was high: 49 of 50 participating cancer programs completed training; 126 of 129 participating individuals completed the training (98% response rate); and 119 completed the training and evaluations (92% response rate). Training increased the mean percentage change in knowledge scores by 19%-45% across key concepts (eg, causes of health disparities) and increased the mean percentage change in knowledge scores by 10%-31% about strategies/actions to address implicit bias and diversity concerns in cancer clinical trials. Knowledge increases were sustained at 6 weeks. Qualitative evaluation validated the utility and feasibility of facilitated peer-to-peer discussion. CONCLUSION: The pilot implementation of the training program demonstrated excellent utility and feasibility. Our evaluation affirms that an online training designed to raise awareness about implicit bias and develop strategies to mitigate biases among cancer research teams is feasible and can be readily implemented in cancer research settings.

Healthcare providers' attitudes towards delay in cancer treatment during COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has created unprecedented obstacles leading to delays in treatment for older adults with cancer. Due to limited resources at the height of the pandemic, healthcare providers were constantly faced with ethical dilemmas regarding postponing or rescheduling care for their patients. MATERIALS AND METHODS: Two survey-based studies were conducted at different time-points during the pandemic looking at factors affecting oncology care providers' attitudes towards delay in treatment for older adults with cancer. Eligible participants were recruited by email sent through professional organizations' listservs, email blasts, and social media. Change in provider attitude over time was analyzed by comparing responses from the 2020 and 2021 surveys. Data analysis included descriptive statistics and chi-squares. RESULTS: In 2020, 17.5% of respondents were strongly considering/considering postponing cancer treatment for younger patients (age 30 and below), while 46.2% were considering delaying treatment for patients aged >85. These responses were in stark contrast to the results of the 2021 survey, where only 1.4% of respondents strongly considered postponing treatment for younger patients, and 13.5% for patients aged >85. DISCUSSION: All recommendations to postpone treatment for older adults with cancer must be made after mutual discussion with the patient. Throughout the COVID-19 pandemic, oncology care providers had to consider multiple factors while treating patients, frequently making most decisions without appropriate institutional support.

Resource and Reimbursement Barriers to Comprehensive Cancer Care Delivery: An Analysis of Association of Community Cancer Centers Survey Data.

PURPOSE: Comprehensive cancer care (CCC) delivery is recommended in guidelines and considered essential for high-quality cancer management. Barriers, such as insufficient reimbursement, prevent consistent access to and delivery of CCC. Association of Community Cancer Centers conducted a national survey to elucidate capacity and barriers to CCC delivery to inform policy and value-based payment reform. METHODS: Survey methodology included item generation with expert review, iterative piloting, and cognitive validity testing. In the final instrument, 27 supportive oncology services were assessed for availability, reasons not offered, and coverage/reimbursement. RESULTS: 204 of 704 member programs completed survey questions. Despite most services being reported as offered, a minority were funded through insurance reimbursement. The services least likely to obtain reimbursement were those that address practical and family/childcare needs (0.7%), caregiver support (1.5%), advanced care directives (1.7%), spiritual services (1.8%), and navigation (2.7%). These findings did not vary by region or practice type. CONCLUSION: There is a lack of sufficient reimbursement, staffing, and budget to provide CCC across the United States. Care models and reimbursement policies must include CCC services to optimize delivery of cancer care.

Differences in urban and suburban/rural settings regarding care provision and barriers of cancer care for older adults during COVID-19.

PURPOSE: Care for older adults with cancer became more challenging during the COVID-19 pandemic, particularly in urban hotspots. This study examined the potential differences in healthcare providers' provision of as well as barriers to cancer care for older adults with cancer between urban and suburban/rural settings. METHODS: Members of the Advocacy Committee of the Cancer and Aging Research Group, with the Association of Community Cancer Centers, surveyed multidisciplinary healthcare providers responsible for the direct care of patients with cancer. Respondents were recruited through organizational listservs, email blasts, and social media messages. Descriptive statistics and chi-square tests were used. RESULTS: Complete data was available from 271 respondents (urban (n = 144), suburban/rural (n = 127)). Most respondents were social workers (42, 44%) or medical doctors/advanced practice providers (34, 13%) in urban and suburban/rural settings, respectively. Twenty-four percent and 32.4% of urban-based providers reported "strongly considering" treatment delays among adults aged 76-85 and > 85, respectively, compared to 13% and 15.4% of suburban/rural providers (Ps = 0.048, 0.013). More urban-based providers reported they were inclined to prioritize treatment for younger adults over older adults than suburban/rural providers (10.4% vs. 3.1%, p = 0.04) during the pandemic. The top concerns reported were similar between the groups and related to patient safety, treatment delays, personal safety, and healthcare provider mental health. CONCLUSION: These findings demonstrate location-based differences in providers' attitudes regarding care provision for older adults with cancer during the COVID-19 pandemic.

Improving Cancer Care Delivery: Learnings for Oncology Nurses and Patient Navigation From a National Quality Survey.

Background: Although implementation of patient navigation programs in clinical practice is widespread, heterogeneity exists in the design and delivery of these services. Greater clarity is required on competencies of personnel, delineation of their roles in multidisciplinary cancer care teams, navigation service components that positively impact patient outcomes, and associated metrics. Methods: A national, double-blind, online survey was implemented between January 24, 2019, and April 25, 2019, to investigate care coordination for advanced (stage III/IV) non-small cell lung cancer (NSCLC). Respondents included multidisciplinary team (MDT) members, such as oncologists, pathologists, oncology nurses, advanced practice nurses, and patient navigators, from US cancer programs. Customized questions covered NSCLC screening, diagnosis, treatment, and care coordination, with a focus on oncology nurses, advanced practice nurses, and patient navigation. Descriptive statistics were computed. Subanalyses examined relationships between care delivery and outcomes such as shared decision-making (SDM) through statistical testing. Results: Across programs, there was a lack of patient (nurse or lay) navigators (22.3%, 101/452) to assist patients with NSCLC. Most respondents (90.1%, 100/111) worked in programs with no formal health literacy assessments. Significantly higher mean SDM scores (p < .05) were observed in programs with patient navigators compared with programs without these specialists. Conclusion: Patient navigation is pivotal to enhancing the patient experience along the lung cancer care continuum and should be strategically integrated within lung cancer MDTs. These findings, along with survey inputs from other MDT disciplines, can help support process improvement plans for patient-centered advanced NSCLC care delivery.

Assessing Breast Cancer Risks to Improve Care for an Increased-Risk Population within Eastern North Carolina.

BACKGROUND The average lifetime risk of breast cancer for an American woman is 12.5%, but individual risks vary significantly. Risk modeling is a standard of care for breast cancer screening and prevention with recommended tools to stratify individual risks based on age, family history, breast density, and a host of other known risk factors. Because of a lack of resources rurally, we have not consistently met this standard of care within all of North Carolina.METHODS We implemented a quality improvement project to assess the risk for breast cancer by gathering data on community risks. We implemented an evidence-based tool (Tyrer-Cuzick) for quantifying risk within a mostly rural population of Eastern North Carolina and developed customized services for women meeting elevated-risk definition. These services included additional imaging for elevated-risk women and a risk-reduction program. We also assessed genetic risks for hereditary breast and ovarian cancer in our at-risk population using National Comprehensive Cancer Network (NCCN) guidelines based on family history and added local genetics extenders to help test more women. We analyzed data regularly using Plan-Do-Study-Act methods to improve outcomes over 1 year.RESULTS We screened a population of 4500 women at a community hospital over a 1-year period for their individual lifetime cancer risk and genetic risk. Breast cancer risk was quantitated at the time of mammography, and women were stratified into 3 groups for risk management. Within our screening population, 6.3% of women were at high risk (defined by a lifetime breast cancer risk greater than or equal to 20%) and another 8.1% were above-average risk (defined by a lifetime breast cancer risk of 15%-20%). These women (14.4%) could potentially benefit from additional risk-management strategies. Additionally, 20% of all unaffected women within a typical screening population of Eastern North Carolina met NCCN guidelines for hereditary breast cancer and ovarian cancer testing independent of their cancer risk score. Using a model of targeted intervention within a population with elevated risks can be helpful in improving outcomes.LIMITATIONS This population within Eastern North Carolina is mostly rural and represents a potentially biased population, as it involves older women undergoing annual mammography. It may not be broadly applicable to the entire population based on age, geography, and other risks.CONCLUSIONS This model for improving cancer risk assessment and testing at a small community hospital in Eastern North Carolina was successful and addressed a community need. We discovered a high rate of increased-risk women who can benefit from individualized risk management, and a higher percentage of women who potentially benefit from genetic testing. These higher cumulative risks may in part explain some of the disparities seen for breast-cancer-specific outcomes in some parts of the state.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

Role of Oncology Advanced Practitioners to Enhance Clinical Research.

Background: Oncology advanced practitioners (APs), including nurse practitioners, clinical nurse specialists, physician assistants, and clinical pharmacists contribute significantly to quality cancer care. Advanced practitioners enhance value across the spectrum of cancer care. Research is an underdeveloped component of quality care, as well as an underdeveloped component of AP practice. Understanding research-related attitudes and roles of APs could lead to enhanced clinical trial accrual, conduct, and protocol development. Methods: A nationwide survey addressing attitudes, beliefs, and roles of APs regarding clinical research was distributed by the Association of Community Cancer Centers (ACCC) and Harborside in early 2020. Results: 408 oncology APs completed the survey. Thirty-five percent practice in an academic setting and 62% in the community. Nearly all respondents believe clinical trials are important to improve care, and over 90% report clinical trials are available at their practice. About 80% report being comfortable discussing the topic of clinical trials with patients and are involved in the care of trial participants. Sixty percent are comfortable discussing available trials, and 38% routinely explore available trials with patients. While 70% report approaching eligible patients about trials, only 20% report doing so "a great deal" or "a lot." Ninety percent report that APs should play a role in clinical research, and 73% want to be more involved. Barriers identified to greater AP clinical trial involvement include lack of time, inadequate awareness of trial specifics, and a lack of a formal role in protocol development and leadership. Conclusions: Advanced practitioners are engaged and interested in clinical trials and believe clinical research is important to improve cancer care. Multidisciplinary team integration, trials-related education, and policy change are needed to employ APs to their full potential within cancer clinical trials.

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations.

The high lethality of ovarian cancer in the United States and associated complexities of the patient journey across the cancer care continuum warrant an assessment of current practices and barriers to quality care in the United States. The objectives of this study were to identify and assess key components in the provision of high-quality care delivery for patients with ovarian cancer, identify challenges in the implementation of best practices, and develop corresponding quality-related recommendations to guide multidisciplinary ovarian cancer programs and practices. This multiphase ovarian cancer quality-care initiative was guided by a multidisciplinary expert steering committee, including gynecologic oncologists, pathologists, a genetic counselor, a nurse navigator, social workers, and cancer center administrators. Key partnerships were also established. A collaborative approach was adopted to develop comprehensive recommendations by identifying ideal quality-of-care program components in advanced epithelial ovarian cancer management. The core program components included: care coordination and patient education, prevention and screening, diagnosis and initial management, treatment planning, disease surveillance, equity in care, and quality of life. Quality-directed recommendations were developed across 7 core program components, with a focus on ensuring high-quality ovarian cancer care delivery for patients through improved patient education and engagement by addressing unmet medical and supportive care needs. Implementation challenges were described, and key recommendations to overcome barriers were provided. The recommendations emerging from this initiative can serve as a comprehensive resource guide for multidisciplinary cancer practices, providers, and other stakeholders working to provide quality-directed cancer care for patients diagnosed with ovarian cancer and their families.

Improving Care for Patients With Stage III or IV NSCLC: Learnings for Multidisciplinary Teams From the ACCC National Quality Survey.

PURPOSE: Insufficient characterization of the optimal multidisciplinary team and lack of understanding of barriers to quality care are unmet needs in the management of stage III or IV non-small-cell lung cancer (NSCLC). A national survey was conducted to inform the design and execution of process improvement plans and address identified barriers. METHODS: A steering committee of multidisciplinary specialists and representation from patient advocacy collaborated for a comprehensive, double-blind, web-based survey (January-April 2019) to obtain insights on care delivery for patients with advanced NSCLC in a diverse set of US community cancer programs. RESULTS: Overall, 639 responses (160 unique cancer programs across 44 US states) were included; 41% (n = 261) of respondents indicated an absence of a thoracic multidisciplinary clinic in their cancer program. Engagement in shared decision making was significantly associated with the presence of navigation and radiation oncology disciplines (P ≤ .04); 19.2% and 33.3% of respondents belonged to cancer programs with no lung cancer screening and no protocol for biomarker testing, respectively. The frequency of tumor board meetings negatively correlated with time to complete disease staging (P = .03); the average time to first therapeutic intervention in newly diagnosed patients was 4 weeks. The most challenging barriers to quality care included insufficient quantity of biopsy material for biomarker testing, lack of primary care provider referrals, and diagnostic costs. CONCLUSION: Improving the quality of advanced NSCLC care, including optimization of a multidisciplinary team framework, may surmount barriers to care coordination, diagnosis and staging, and treatment planning, consequently improving adherence to evolving standards of care.

Survey of cancer care providers' attitude toward care for older adults with cancer during the COVID-19 pandemic.

OBJECTIVES: Care for older adults with cancer became more challenging during the COVID-19 pandemic. We sought to examine cancer care providers' attitudes toward the barriers and facilitators related to the care for these patients during the pandemic. MATERIALS AND METHODS: Members of the Advocacy Committee of the Cancer and Aging Research Group, along with the Association of Community Cancer Centers, developed the survey distributed to multidisciplinary healthcare providers responsible for the direct care of patients with cancer. Participants were recruited by email sent through four professional organizations' listservs, email blasts, and messages through social media. RESULTS: Complete data was available from 274 respondents. Only 15.4% had access to written guidelines that specifically address the management of older adults with cancer during the COVID-19 pandemic. Age was ranked fifth as the reason for postponing treatment following comorbid conditions, cancer stage, frailty, and performance status. Barriers to the transition to telehealth were found at the patient-, healthcare worker-, and institutional-levels. Providers reported increased barriers in accessing basic needs among older adults with cancer. Most respondents agreed (86.3%) that decision making about Do Not Resuscitate orders should be the result of discussion with the patient and the healthcare proxy in all situations. The top five concerns reported were related to patient safety, treatment delays, healthcare worker mental health and burnout, and personal safety for family and self. CONCLUSION: These findings demand resources and support allocation for older adults with cancer and healthcare providers during the COVID-19 pandemic.