Austin, Jessica D.

AbstractObjectivesTo report lessons from integrating the methods and perspectives of clinical informatics (CI) and implementation science (IS) in the context of Improving the Management of symPtoms during and following Cancer Treatment (IMPACT) Consortium pragmatic trials.Materials and MethodsIMPACT informaticists, trialists, and implementation scientists met to identify challenges and solutions by examining robust case examples from 3 Research Centers that are deploying systematic symptom assessment and management interventions via electronic health records (EHRs). Investigators discussed data collection and CI challenges, implementation strategies, and lessons learned.ResultsCI implementation strategies and EHRs systems were utilized to collect and act upon symptoms and impairments in functioning via electronic patient-reported outcomes (ePRO) captured in ambulatory oncology settings. Limited EHR functionality and data collection capabilities constrained the ability to address IS questions. Collecting ePRO data required significant planning and organizational champions adept at navigating ambiguity.DiscussionBringing together CI and IS perspectives offers critical opportunities for monitoring and managing cancer symptoms via ePROs. Discussions between CI and IS researchers identified and addressed gaps between applied informatics implementation and theory-based IS trial and evaluation methods. The use of common terminology may foster shared mental models between CI and IS communities to enhance EHR design to more effectively facilitate ePRO implementation and clinical responses.ConclusionImplementation of ePROs in ambulatory oncology clinics benefits from common understanding of the concepts, lexicon, and incentives between CI implementers and IS researchers to facilitate and measure the results of implementation efforts.

PURPOSE The enhanced, electronic health record (EHR)–facilitated cancer symptom control (E2C2) trial is a cohort cluster-randomized, stepped-wedge, hybrid type II trial that leverages EHR systems to facilitate a collaborative care model (CCM) approach with the goal of improving cancer symptom management. Understanding factors that influence care team adoption of EHR systems remains a critical understudied area of research. This study examines how oncology care teams' perceptions regarding the feasibility, acceptability, and appropriateness of E2C2 EHR systems preimplementation were associated with adoption 3 months after implementation and characterizes differences in adoption by individual- and system-level factors. METHODS Care team members completed an electronic survey before and 3 months after implementation of E2C2 for their respective sequence. Adoption was defined as frequency of use to statements aligned with care team–directed EHR systems designed to facilitate CCM approaches. Chi-square tests assessed differences in adoption while logistic regression models estimated associations between baseline mean scores of acceptability, feasibility, and appropriateness on care team adoption at 3 months. RESULTS Results from 94 care team members (37.2% oncologists, 72.6% female, 55.3% in their role for 6+ years) found that adoption rates ranged from 48.9% to 71.7%, with significant differences observed by location (community-based health care systems v tertiary medical center) and professional role. Adjusting for professional role, care team members reporting higher levels of perceived acceptability and appropriateness at baseline had greater odds of adopting EHR systems at 3 months. CONCLUSION EHR systems perceived as acceptable and appropriate are more likely to be adopted by oncology care teams in our sample. Future implementation efforts should consider tailored strategies to facilitate adoption of EHR systems designed to promote CCM-based approaches to improve cancer symptom management.

12065 Background: Incidence of cancer, including colorectal, breast, pancreas, kidney, and uterine cancer, is increasing in younger populations. Adolescents and young adults (AYA, defined as age 15-39) with cancer face unique challenges. This study aimed to characterize how symptom burden differs between AYA and non-AYA (aged 40+) patients with cancer. Methods: We performed a subgroup analysis of the E2C2 study, a cluster-randomized, pragmatic trial examining the effectiveness of routine symptom assessment and guideline-based management on patient-centered and healthcare utilization metrics during and following cancer treatment. Six symptoms [Sleep disturbance, Pain, Physical function impairment, Anxiety, Depression, and Energy deficit/fatigue (SPPADE)] were evaluated using 11-point numerical rating scales (NRS). Symptom severity was classified as mild (0-3), moderate (4-6), or severe (7-10). We conducted a subgroup analysis of symptom burden among AYA patients (defined as age 18-39 in this study), using their first-reported NRS scores. Results: The E2C2 cohort included 2,598 AYA patients and 38,061 non-AYA patients who completed >1 SPPADE NRS on at least one survey. AYA patients were more likely than non-AYA patients to report severe anxiety ( p<0.0001) and depression ( p<0.0001) (Table). Non-AYA patients were more likely to report severe pain ( p=0.02179), fatigue ( p=0.0022), and physical function limitations ( p<0.0001). Sociodemographic differences were also noted. A higher proportion of AYA patients held a bachelor’s degree or higher (38% vs 28%), were employed (73% vs 37%), and lived in an urban setting (67% vs 56%), compared to non-AYA patients. Non-AYA patients were more likely to have government insurance (63% vs 21%) and to be married (72% vs 59%). Conclusions: AYA patients with cancer were more likely to report severe depression and anxiety compared to their counterparts age 40 and above, underscoring the need for targeted and tailored psycho-oncology care for this population. [Table: see text]

LBA12006 Background: Symptom burden and functional decline are prevalent, inconsistently treated, and associated with adverse health outcomes in patients with cancer. Symptom monitoring with electronic patient-reported outcome measures (ePROMs) has yielded mixed results due, in part, to care teams’ variable bandwidth and resourcing for symptom management. The collaborative care model (CCM) offers a validated means to address these issues and potentially improve clinical and health services outcomes. Capturing ePROMS through the electronic health record (EHR) for use in CCM delivery provides a potentially scalable approach to manage symptoms at the population level. Methods: E2C2 is a cluster-randomized, population-level, stepped wedge pragmatic trial that compares a bundled, EHR-facilitated, CCM-based intervention to improve control of SPPADE symptoms (Sleep interference, Pain, impaired Physical function, Anxiety, Depression, and Energy deficit/fatigue) with usual care. All patients, regardless of cancer type or stage, treated in the medical oncology clinics of a multi-state health system, were assigned to one of fifteen clusters. Control and intervention conditions monitored SPPADE symptoms with Epic EHR administered 11-point numerical rating scales (NRSs). Moderate and severe symptoms were defined as 4-6/10 and >7/10, respectively. The intervention added EHR clinician decision support; automated delivery of symptom self-management information; and options to address severe symptoms with a dedicated symptom care manager. The primary outcome was post-baseline SPPADE scores assessed using multivariate regression of six cluster-period mean SPPADE symptom scores against E2C2 exposure, fixed cluster and secular time effects. Results: From March 2019 to January 2023, 50,559 patients were assigned to E2C2 clusters and 40,295 completed at least one ePROM. At first assessment, participants’ mean age was 63.3 years; 58% were female; 26% were rural, and the prevalences of moderate or worse symptoms were fatigue 42%, impaired function 34%, sleep disturbance 34%, anxiety 27%, pain 26%, and depression 23%. The intervention significantly reduced mean composite SPPADE symptom scores, p <0.001, among all patients, as well as those with >1 moderate or worse symptom. All mean symptom scores were lower in the intervention group, with the largest effects detected among patients with fatigue -0.2 (-0.4, -0.07), anxiety -0.14 (-0.2, -0.03), and depression -0.1 (-0.2, -0.002). Conclusions: In this large cluster-randomized trial, an EHR-facilitated, bundled intervention that scaled CCM-based surveillance and management of SPPADE symptoms significantly reduced population-level symptom burden, particularly for fatigue, anxiety, and depression. This study provides real world evidence and the foundation for future national efforts aimed at controlling symptoms in patients with cancer. Clinical trial information: NCT03892967 .

11108 Background: Advances in cancer treatment have led to a growing population of patients living with metastatic cancer. Symptom burden for these patients is understudied. Our objective is to report the prevalence and severity of SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) in a large cohort of patients with metastatic cancer. Methods: These data are drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) stepped wedge pragmatic trial evaluating a symptom management intervention for cancer patients (NCT03892967). This analysis was limited to those identified with metastatic disease using ICD- codes and a natural language processing algorithm prior to or within 30 days of their baseline symptom survey. Symptom severity was measured on a 0-10 scale with scores of 1-3 categorized as “mild”, 4-6 as “moderate”, and ≥7 as “severe.” A SPPADE composite score was calculated by summing six individual symptom scores and is an indicator of total symptom burden. We report descriptive statistics for each symptom by severity category. We also test for differences in SPPADE composite score by race, disability status, employment status, education and cancer type using Kruskal-Wallis tests. Results: 12,824 patients with metastatic disease completed a survey between March 2019 and January 2023. Discretized score distributions for the SPPADE symptoms are reported in the Table. The SPPADE composite mean score for the cohort was 17.6 (SD +/- 12.0). Significant differences were found in total symptom burden by sociodemographic and clinical characteristics ( p<0.01): Higher total symptom burden (Mean [SD])was experienced by individuals who were American Indian/Alaska Native (AI/AN) (23.8[13.5]) or African American (AA) (20.5[14.7]), disabled (24.0[12.8]) or unemployed (21.1[13.0]), and had a high school education (20.0[13.3]) or less than high school education (18.5[12.4]). There were also statistically significant differences ( p<0.01) in symptom burden across cancer types, with patients with metastatic lung cancer reporting the highest symptom burden (20.0[12.2]) and those with metastatic melanoma reporting the lowest (14.7[11.4]). Conclusions: SPPADE symptoms are common in patients with metastatic cancer, especially fatigue, sleep disturbance, and physical function impairment. Symptom burden is especially high in AI/AN, AA, disabled/unemployed, and less educated patients. Further research is needed to tailor symptom interventions among those living with metastatic disease. [Table: see text]

Abstract INTRODUCTION Disparities in breast cancer (BC) screening are observed between Hispanic and non-Hispanic White women and stronger amongst Hispanic women with under- and uninsured statuses.1-2 Risk-based screening has been recommended by professional societies, including American Cancer Society, starting at age 30 and may be an important strategy for reducing disparities.3 The purpose of the study was to characterize whether women had been told their personal risk of BC and to identify differences in characteristics of patients informed of their personal risk. METHODS This is a cross-sectional analysis of data from a supplemental self-reported survey to an NIH-funded randomized trial conducted at a large Federally Qualified Health Center (FQHC) in Arizona (R01 MD09682-05). The survey was sent to a randomized 600 of the 1,356 participants. Between November 2022 and April 2023, 177 women completed the survey (response rate 29.5%). Participants were asked if a doctor or other healthcare provider had ever talked to them about their personal risk for BC. Differences between those who recalled being told their personal risk for BC and those who did not were assessed using Fisher exact test. RESULTS Overall, 66.3% were 50 years or older, 81.8% who speak primarily Spanish, and 64.8% of respondents had less than a high school education. Also, 22.4% reported a family history of BC, 27.4% have been previously recalled for additional imaging, 10.8% have had a history of prior breast biopsy, 59.9% stated having a regular provider, and 53.1% were found to have dense breast category C or D at screening visit. 40% did not report having a regular doctor although all participants received care at an FQHC. 30.5% of respondents stated that a healthcare professional had ever talked to them about their personal risk for BC. There was a trend toward women with a main doctor being more likely to recall being told their personal risk for BC as compared to those without a main doctor (38.5% vs 22.5%, p=0.06). CONCLUSIONS In this cohort of primarily Spanish-speaking Hispanic women who have had mammography screening and written report of their breast density, about a third of respondents recall being informed of their personal BC risk. These observations need to be confirmed in a larger population with greater response rate, but these results suggest that there is a cohort of patients who need different approaches for conveying risk. REFERENCES 1. Jadav, S., Rajan, S. S., Abughosh, S., & Sansgiry, S. S. (2015). The Role of Socioeconomic Status and Health Care Access in Breast Cancer Screening Compliance Among Hispanics. Journal of Public Health Management and Practice, 21(5), 467–476. https://www.jstor.org/stable/48517175 2. American Cancer Society. (2017). Breast cancer facts & figures 2017-2018. Atlanta, GA: American Cancer Society, Inc. 3. ACS Breast Cancer Screening Guidelines. (2022, January 14). https://www.cancer.org/cancer/types/breast-cancer/screening-tests-and-early-detection/american-cancer-society-recommendations-for-the-early-detection-of-breast-cancer.htm Citation Format: Jhenitza P. Raygoza Tapia, Sarah M. Jenkins, Jennifer L. Ridgeway, Aaron D. Norman, Crystal R. Gonzalez, Valentina Hernandez, Bhavika K. Patel, Celine M. Vachon, Jessica D. Austin. Communicating breast cancer risk to Spanish-speaking Hispanic women [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C126.

Abstract Background: Individuals from diverse racial/ethnic and disadvantaged backgrounds are underrepresented in cancer clinical trials, compounding the difficulty of adequately understanding, addressing, and reversing health inequities. Social determinants of health (SDOH) factors likely contribute to disparities in cancer trial enrollment. While the presence of SDOH has shown to be associated with clinical trial participation, few studies have explored the role of SDOH in shaping beliefs around the benefits of clinical trials. Thus, this study aims to identify SDOH factors associated with beliefs around the benefits of clinical trial participation. Methods: This is a cross-sectional study of data from the Community Health Assets and Resilience Measures survey. The survey was administered in Fall 2021 to community members (N=3593; 98% &gt; 50 years of age, 68% male, 52% racial/ethnic minority) residing in three states within the Mayo Clinic catchment area. Survey items assessed SDOH factors including financial instability, childcare, transportation, food insecurity, safety, literacy, social isolation, and perceived discrimination. Participant beliefs around the benefits of clinical trial participation was measured by rating level of agreement to 4 statements: ‘People in my community can benefit from participating in clinical trials’, ‘Participation in clinical trials benefits society’, ‘Participation in clinical trials is risky’, ‘I would personally benefit’, and ‘People in my community would benefit’. Response options were dichotomized as ‘agree’ and ‘disagree’ and adjusted stepwise logistic regression analyses were performed to assess factors associated with beliefs about clinical trials. Results: Race/ethnicity was significantly associated with all beliefs with Indigenous populations being significantly more likely to agree that people in their community could benefit from clinical trials, clinical trials benefit society, participation in clinical trials is risky, and that they would personally benefit. In adjusted analyses, financial instability, food insecurity, transportation, childcare, safety, social isolation, literacy, and discrimination were significantly associated with beliefs about the benefits of clinical trial participation. Neighborhood safety was most strongly associated with the belief that ‘People in my community can benefit from participating in clinical trials’ and ‘I would personally benefit from clinical trials’. Health literacy was most strongly associated with the belief that clinical trials benefit society and the community. Finally, the experience of 'people act as if they think you are not smart' (discrimination) was most strongly associated with the belief that clinical trials are risky. Conclusion: Clinical trials are the cornerstone to advancing equitable cancer care. Innovative, multifaceted, community-driven strategies are needed that address negative beliefs around the benefits of clinical trial participation to address existing recruitment and retention shortcomings. Citation Format: Jessica D. Austin, Todd Huschka, Amelia Barwise, Megan Allyse, Sean Phelan. The role of social determinants of health on beliefs around the benefits of clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A077.

Trial RegistrationClinicalTrials.gov Identifier: NCT03501992

AbstractCancer and its treatment produce deleterious symptoms across the phases of care. Poorly controlled symptoms negatively affect quality of life and result in increased health-care needs and hospitalization. The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium was created to develop 3 large-scale, systematic symptom management systems, deployed through electronic health record platforms, and to test them in pragmatic, randomized, hybrid effectiveness and implementation trials. Here, we describe the IMPACT Consortium’s conceptual framework, its organizational components, and plans for evaluation. The study designs and lessons learned are highlighted in the context of disruptions related to the COVID-19 pandemic.

Abstract Background Electronic health record–linked portals may improve health-care quality for patients with cancer. Barriers to portal access and use undermine interventions that rely on portals to reduce cancer care disparities. This study examined portal access and persistence of portal use and associations with patient and structural factors before the implementation of 3 portal-based interventions within the Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium. Methods Portal use data were extracted from electronic health records for the 12 months preceding intervention implementation. Sociodemographic factors, mode of accessing portals (web vs mobile), and number of clinical encounters before intervention implementation were also extracted. Rurality was derived using rural-urban commuting area codes. Broadband access was estimated using the 2015-2019 American Community Survey. Multiple logistic regression models tested the associations of these factors with portal access (ever accessed or never accessed) and persistence of portal use (accessed the portal ≤20 weeks vs ≥21 weeks in the 35-week study period). Results Of 28 942 eligible patients, 10 061 (35%) never accessed the portal. Male sex, membership in a racial and ethnic minority group, rural dwelling, not working, and limited broadband access were associated with lower odds of portal access. Younger age and more clinical encounters were associated with higher odds of portal access. Of those with portal access, 25% were persistent users. Using multiple modalities for portal access, being middle-aged, and having more clinical encounters were associated with persistent portal use. Conclusion Patient and structural factors affect portal access and use and may exacerbate disparities in electronic health record–based cancer symptom surveillance and management.