Mitchell, Sandra A

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 Background: SPPADE symptoms (Sleep disturbance, Pain, Physical function impairment, Anxiety, Depression/distress, and Energy deficits/fatigue) may result from cancer and its treatment. The aim of this analysis was to characterize SPPADE symptoms in patients with breast cancer. Methods. SPPADE data were drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) study, a stepped-wedge pragmatic cluster-randomized trial designed to evaluate a symptom management intervention in routine practice (NCT03892967). Symptom severity was measured on a 0-10 scale via a survey administered by patient portal, in-clinic tablet, or interactive voice response system (by phone) prior to, during, or soon after an outpatient oncology encounter. Scores of 4-6 were categorized as “moderate” and ≥7 as “severe.” In this analysis, only the data from each patient’s initial survey were included. Results. A total of 9,651 patients with breast cancer completed an initial E2C2 survey between March 2019 and January 2023. The proportion of patients with moderate or severe SPPADE symptoms were as follows: 22% moderate and 10% severe for insomnia; 18% moderate and 7% severe for pain; 17% moderate and 7% severe for anxiety; 15% moderate and 5% severe for emotional distress; 25% moderate and 12% severe for fatigue; and 22% moderate and 8% severe for impaired physical function. Table 1 presents score means and standard deviations by demographic subgroup. Conclusions. SPPADE symptoms are common in patients with breast cancer. These observations warrant routine implementation of symptom surveillance and management in breast oncology. Funding acknowledgement: The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium is a Cancer Moonshot Research Initiative under the authorization of the 2016 United States 21st Century Cures Act. This research was supported by the National Cancer Institute of the NIH, UM1CA233033 (Mayo Clinic, Rochester, MN). Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer Citation Format: Kathryn Ruddy, Veronica Grzegorczyk, Deirdre Pachman, Sandra Mitchell, Bolun Liu, Deanne Smith, Ciara O'Sullivan, Shawna Ehlers, Jeph Herrin, Parvez Rahman, Andrea Cheville. Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-09.

31 Background: Incidence of early-onset colorectal cancer (eoCRC, <50 years of age at diagnosis) is increasing globally. However, little is known regarding symptom burden in this sub-population. We compared symptoms in patients with eoCRC to those of patients with average-onset CRC (aoCRC, diagnosed at age ≥ 50). Methods: E2C2 is a stepped-wedge, cluster-randomized pragmatic trial evaluating a collaborative care model for the assessment and management of six symptoms [Sleep disturbance, Pain, Physical function impairment, Anxiety, emotional Distress, and Energy deficit (SPPADE)]. Patients were asked to complete assessments rating each of these symptoms on an 11-point numerical rating scale. Symptom severity was classified as mild (0-3), moderate (4-6), or severe (7-10). We conducted a subgroup analysis of patients with CRC, comparing SPPADE symptoms on an initial survey, regardless of timing in treatment course, between patients with eoCRC and aoCRC. Results: Patients with CRC (n=4281) completed a survey between March 2019 and December 2022. Patient demographics and SPPADE symptoms are reported in the table. Patients with eoCRC were more likely to report severe sleep disturbance ( p<0.0001), pain ( p=0.03485), anxiety ( p<0.0001), emotional distress ( p<0.0001), and fatigue ( p=0.01083). In patients with eoCRC, women were more likely to report severe pain (12.6% vs 6.9%, p=0.0069), anxiety (16.1% vs 10.0%, p=0.012), emotional distress (12.1% vs 5.4%, p=0.00066), fatigue (18.9% vs 13.4%, p=0.038), and physical function impairment (10.1% vs 5.8%, p=0.026) compared to men. Conclusions: Patients with eoCRC reported higher symptom severity than patients with aoCRC. This suggests unique needs for symptom management in patients with eoCRC. Additional research is needed to evaluate how time since diagnosis, disease characteristics, cancer-directed treatment patterns, and co-occurring symptoms are associated with specific symptoms in this population. [Table: see text]

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.

PURPOSE The standard of care for locally advanced rectal cancer in North America is neoadjuvant pelvic chemoradiation with fluorouracil (5FUCRT). Neoadjuvant chemotherapy with fluorouracil and oxaliplatin (FOLFOX) is an alternative that may spare patients the morbidity of radiation. Understanding the relative patient experiences with these options is necessary to inform treatment decisions. METHODS PROSPECT was a multicenter, unblinded, noninferiority, randomized trial of neoadjuvant FOLFOX versus 5FUCRT, which enrolled adults with rectal cancer clinically staged as T2N+, cT3N–, or cT3N+ who were candidates for sphincter-sparing surgery. Neoadjuvant FOLFOX was given in six cycles over 12 weeks, followed by surgery. Neoadjuvant 5FUCRT was delivered in 28 fractions over 5.5 weeks, followed by surgery. Adjuvant chemotherapy was suggested but not mandated in both groups. Enrolled patients were asked to provide patient-reported outcomes (PROs) at baseline, during neoadjuvant treatment, and at 12 months after surgery. PROs included 14 symptoms from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Additional PRO instruments measured bowel, bladder, sexual function, and health-related quality of life (HRQL). RESULTS From June 2012 to December 2018, 1,194 patients were randomly assigned, 1,128 initiated treatment, and 940 contributed PRO-CTCAE data (493 FOLFOX; 447 5FUCRT). During neoadjuvant treatment, patients reported significantly lower rates of diarrhea and better overall bowel function with FOLFOX while anxiety, appetite loss, constipation, depression, dysphagia, dyspnea, edema, fatigue, mucositis, nausea, neuropathy, and vomiting were lower with 5FUCRT (all multiplicity adjusted P < .05). At 12 months after surgery, patients randomly assigned to FOLFOX reported significantly lower rates of fatigue and neuropathy and better sexual function versus 5FUCRT (all multiplicity adjusted P < .05). Neither bladder function nor HRQL differed between groups at any time point. CONCLUSION For patients with locally advanced rectal cancer choosing between neoadjuvant FOLFOX and 5FUCRT, the distinctive PRO profiles inform treatment selection and shared decision making.

419 Background: The patient portal is part of an electronic health record (EHR) that allows patients to communicate with their healthcare team. The portal also provides a platform for patients to receive and complete symptom surveys that can be directly integrated into the EHR, allowing clinical care teams to monitor symptoms and provide cancer symptom management. The Improving Management of symPtoms during And following Cancer Treatment (IMPACT) consortium, supported by the National Cancer Institute’s Cancer MoonshotSM, aims to improve symptom control for cancer patients through assessment and symptom management interventions deployed via the EHR. This initiative presents an opportunity to examine portal enrollment and variation in use, factors critical to successful implementation, especially among groups that have high cancer symptom burden. To this end, we examine: 1) relationships between portal enrollment prior to the launch of IMPACT interventions and neighborhood broadband access, demographic, and social characteristics; and 2) frequency of pre-intervention portal use for any purpose among enrollees. Methods: Data are derived from two of three IMPACT research centers. Enrollment in and frequency of portal use, mode of accessing the portal (web vs. phone), social, demographic, and cultural factors were extracted from the EHR. Rural Urban Commuting Area (RUCA) codes were used to classify population density and degree of rurality. Broadband access was estimated using 2015-2019 American Community Survey estimates matched to zip codes from enrolled IMPACT patients and classified as a patient’s residence being in a community with high (≥85% of households) or low (< 85% of households) access. Bivariate comparisons and adjusted odds ratios were used to describe all associations. Results: Forty-seven percent of patients (22,596/48,034) were enrolled in the portal prior to the intervention. Patients in zip codes with low broadband access and those who were men, > 65 years old, not White, of Hispanic ethnicity, or disabled or not employed had significantly lower odds of being enrolled in the portal. If enrolled, 21% (n = 4825) used the portal at least once a week. Less variation was found in the average frequency of portal use, but patients younger than 40, and those who were Black, disabled, unemployed, or those who used a mobile device to access the portal had the lowest odds of accessing it at least once a week. Conclusions: Significant disparities in portal enrollment exist across demographic groups and among those with limited broadband access. Among those enrolled, most used the portal less than once a week. Fewer differences in frequency of use were observed by sociodemographic factors. Improving portal enrollment and frequency of use may be critical for symptom management interventions deployed via patient portals.

Abstract Background The symptom burden associated with cancer and its treatment can negatively affect patients’ quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. Methods In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to “opt-in” to receive a call, but the protocol was later modified so they had to “opt-out” if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. Results Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P &lt; .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. Conclusions Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.