Sleep disturbances are underidentified and undertreated in oncology. To inform screening and intervention efforts at a large academic cancer center, we identified the prevalence and correlates of patient-reported sleep difficulties. This retrospective study evaluated 20,416 individuals who completed practice-based distress screening from January 2017 to June 2024. Sleep difficulties in the past 2 weeks were reported from 0 (none) to 10 (severe). Uni- and multivariable regression models evaluated the impact of sociodemographic factors (age, sex, race/ethnicity, financial concerns) and medical/psychosocial factors (cancer type/stage, time since diagnosis, distress, anxiety, depression, pain, relationship problems, tobacco and alcohol use) on clinically significant (≥5) and severe (≥7) sleep difficulties. All variables were obtained from patients' first screen, except for cancer type, stage, and diagnosis date, which were from the cancer registry. Among the sample (59% female, 78% non-Hispanic white, 49% stage I to II, mixed cancer sites), 36% reported clinically significant sleep difficulties. In a multivariable model, the strongest correlates (OR ≥ 1.35) of sleep difficulties ≥5 were as follows: age 40 to 64 (OR = 1.35), financial concerns (OR = 1.35), distress (OR = 3.06), pain (OR = 2.80), anxiety (OR = 2.31), and depression (OR = 1.69). Risk varied by cancer type, with upper gastrointestinal, genitourinary, thoracic, and hematologic cancers showing modestly higher odds. Sensitivity analyses (cutoff ≥7, within 90 days of diagnosis) showed broadly similar but not identical correlates. Sleep difficulties are prevalent and correlated with psychosocial concerns and cancer type. Future research should explore sleep trajectories and potential care pathways for patients screening positive. SIGNIFICANCE:This large, multicenter study demonstrates that sleep difficulties are highly prevalent among oncology outpatients and are strongly associated with psychosocial distress, pain, and cancer type. Routine screening can identify at-risk patients, supporting the need for integrated, multisymptom management strategies to improve outcomes in cancer care.

Importance:Patients with breast cancer (BC) may have long-term fatigue after treatment, which is associated with reduced quality of life. Objective:To identify cardiac, psychological, and cancer treatment factors associated with fatigue before and 24 months after BC treatment. Design, Setting, and Participants:This cohort study was conducted across multiple community hospital-based cancer centers among participants with stage I to III BC receiving potentially cardiotoxic chemotherapy or aromatase inhibitors and noncancer comparators. Participants were enrolled from May 2017 to July 2021 and followed up for 24 months. Data were analyzed between July 2023 and July 2026. Exposures:Fatigue was assessed by the Functional Assessment of Chronic Illness Therapy Fatigue scale. Main Outcomes and Measures:It was hypothesized that chemotherapy-associated changes in left ventricular function were associated with and mediated 2-year post-BC treatment fatigue. Outcome measures included fatigue, sociodemographic variables, hematocrit, left ventricular ejection fraction and circumferential strain, cardiovascular comorbidities, 6-minute walk distance, perceived stress, and depressive symptoms. Results:From a total of 381 patients, patients with BC (236) and noncancer comparators (145) had a mean (SD) age of 54 (12) years. Two years after BC treatment, 33 (18.2%) receiving potentially cardiotoxic chemotherapy experienced clinically relevant fatigue (χ2 test P < .001 relative to aromatase inhibitors or controls), and 62 (34.6%) experienced a significant increase in fatigue relative to their precancer treatment fatigue level (χ2 test P < .001, relative to aromatase inhibitors and controls). Independent of pretreatment and posttreatment left ventricular ejection fraction, diabetes status, hypertension, tobacco use, age, body mass index, hematocrit, receipt of potentially cardioprotective medications, and chemotherapy regimens, only depressive symptoms (estimate, -0.77; 95% CI, -0.83 to -0.71; P < .001) and perceived stress (-0.32; 95% CI, -0.41 to -0.24; P < .001) were associated with and mediated 24-month post-BC treatment fatigue measures. Baseline adjusted changes in 6-minute walk distance, left ventricular ejection fraction, and left ventricular strain were not associated with 24-month post-BC treatment fatigue levels. Conclusions and Relevance:In this cohort study of patients with BC, clinically relevant fatigue increased in 34% of patients 2 years after initiating cancer treatment mediated partly by depressive symptoms and perceived stress regardless of cardiovascular risk factors, age, or change in left ventricular ejection fraction and/or strain. Trial Registration:ClinicalTrials.gov Identifier: NCT02791581.

Sensitivity analyses: correlates of severe sleep difficulties (≥7/10) among adult patients with cancer in uni- and multivariable logistic regression models (N = 20,416).

BACKGROUND:Engaging community stakeholders in clinical trials planning identifies participation barriers and facilitators to support future trial success. We assessed interest and perceived capacity of the National Cancer Institute Community Oncology Research Program (NCORP) practices and engaged stakeholders to inform a future multisite clinical trial involving caregivers. METHODS:A cross-sectional survey of NCORP practices (WF-2300CD) assessed interest (somewhat or very likely to participate) and capacity (ie, criteria: ≥5 eligible dyad accruals per quarter, identification of necessary study implementers) and barriers and facilitators to participating in a future cancer caregiver-focused trial. Interest and capacity were estimated with 95% confidence intervals (CIs), and logistic regression was used to identify statistically significant predictors. Free-text responses were analyzed using content analysis. RESULTS:Among 136 initial responding practices, 126 (92%) completed the survey (November 2023-April 2024), 56% saw at least 1000 new patient cases annually, 13.5% served at least 30% racial and ethnic minority patients, and 13.5% were designated critical access hospitals. Overall, 84.9% (95% CI = 77.5% to 90.1%) expressed interest in a caregiver-focused trial, but only 37.3% (95% CI = 28.9% to 46.4%) met all capacity criteria; capacity was the sole predictor of interest (adjusted odds ratio [OR] = 5.79, 95% CI = 1.23 to 27.13). Most (88.9%) practices estimated 5 or more eligible caregiver-patient dyads per quarter, but only 44.4% believed they could accrue that amount. Key participation barriers included staffing limitations and challenges related to eligibility and recruitment. Practices emphasized clear guidance on dyad eligibility, recruitment materials, workflow training, and resource considerations to improve trial participation. CONCLUSION:Early stakeholder engagement identified actionable barriers and produced practice-aligned strategies to enhance caregiver trial participation in community oncology settings. Targeted capacity building may improve participation for future caregiver-focused trials.

Background Family caregivers of patients with lung cancer experience high levels of unmet needs, burden, and distress, yet systematic processes to identify and connect caregivers with resources are lacking in community oncology. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a hybrid intervention delivered through a combination of web-based components and telephone-based navigation to inform caregivers about resources, assess their needs, and connect them to tailored supportive care services. Initial pilot testing at a single academic center demonstrated feasibility and acceptability, but feasibility in community settings remains untested. In this study, we aim to assess the multi-site feasibility of CONNECT. Methods This multi-site, randomized controlled pilot trial (WF-2301CD) is conducted through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Lung cancer caregiver-patient dyads (N = 120) are recruited from 12 community oncology practices and randomized to: CONNECT, generic resource list, or usual care. The primary objective is to assess multi-site feasibility, measured by caregiver retention at 12-weeks. Secondary objectives include evaluating caregiver accrual, participation, retention at 24-weeks, and acceptability, as well as process metrics. Exploratory objectives assess patient accrual, participation and retention. Data are collected via surveys at baseline, 12-, and 24-weeks, with additional process tracking by site staff and navigators. Discussion This trial will provide critical data on the multi-site feasibility of implementing CONNECT in community oncology practices to inform protocol and design refinements for a future efficacy trial. If feasible, future efficacy testing will focus on the impact of CONNECT on caregiver burden and distress.NCT06383988

Achieving demographically representative samples remains a challenge in oncology trials but is essential for generalizable findings. We describe recruitment and enrollment to a decentralized trial for an online sexual health intervention for breast cancer survivors, evaluating differences by race, ethnicity, and age. Partnered breast cancer survivors with sexual concerns were recruited to the Sexual Health and Intimacy Enhancement (SHINE) trial (WF-2202, NCT06216574) via the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base. Sites identified potentially eligible survivors; recorded their race, ethnicity, and age; and sent them online eligibility screeners. Eligible, consenting survivors were enrolled. Screener completion (78.3

Breast cancer (BC) survival has improved but is often offset by adverse effects, including reduced exercise capacity. Research in the general population suggests that social support may mitigate exercise capacity declines. However, this relationship in BC survivors has not been examined. This analysis sought to examine relationships between social support overall (and within social support subscales) and exercise capacity declines at 3 months in BC survivors during treatment in relation to cancer-free controls. In 230 BC (stage I-III) survivors and 128 cancer-free controls within the UPBEAT Study (NCT02791581), submaximal exercise capacity and social support were obtained via 6-Minute Walk Distance (6MWD) and MOS Social Support survey, respectively, at baseline and 3 months. Linear regression examined associations between social support and 6MWD declines in BC survivors and controls at 3 months. Declines in 6MWD were associated with social support ( β = 23.8; P = .03). Positive social interactions showed the greatest reduction during BC treatment (P = .02). Whereas no association was observed in controls, in BC survivors lower positive social interaction was associated with 6MWD declines ( β = 23.8; P = .03; p int = 0.02). The findings suggest the importance of social support, particularly positive social interactions, during BC treatment.

Background. To examine the feasibility of adding ramipril for prevention of cognitive decline to chemoradiation treatment of glioblastoma (GBM). Methods. This prospective single-arm study (WF-1801) coordinated by the Wake Forest NCI Community Oncology Research Program Research Base (UG1CA189824) assessed feasibility, tolerability, and potential efficacy of ramipril to prevent treatment-induced cognitive decline in patients with GBM. Inclusion criteria and chemoradiotherapeutic paradigms were mirrored to the standard arm of NRG/RTOG 0825, such that cognitive outcomes could be compared. All patients were treated with ramipril during chemoradiation and for 4 weeks after completion of radiotherapy (RT). Major outcomes were retention and the Clinical Trial Battery Composite (CTB COMP) score of the cognitive tests. Results were compared to the corresponding outcomes from NRG/RTOG 0825. Results. A total of 75 participants were accrued between March 25, 2019 and November 14, 2023: median age was 63 years. The NRG/RTOG 0825 cohort was younger (median 57 years, P < .0001). Overall retention rate at 1-month post-RT (defined as compliant with 75% of doses and completion of cognitive testing) was 48% (1-sided 95% CI: 38%-100%); 61% of patients completed more than 75% of doses and 57% had a CTB COMP score through week 10. The median (range) change in the CTB COMP score at 1 month after RT completion was 0.01 (-82.6, 13.0) versus NRG/RTOG 0825 median of 0.10 (-48.2, 8.6); P = .49. Conclusions. The ramipril intervention did not meet the prespecified feasibility endpoint, neither did the cognitive scores differ significantly from the NRG/RTOG 0925 control group. We expect other agents will be the focus of future cytoprotective trials.

Breast cancer (BC) survivors report declines in health-related quality of life (HRQoL), including worsening physical function and fatigue levels. It is uncertain if these changes are associated with muscle quality. This study estimated changes in muscle quality and HRQoL in BC participants over 24 months of treatment and tested associations with muscle quality and HRQoL. Women (n = 149, 50.3 ± 10.7 years) diagnosed with stage I-III BC (PREVENT-WF-98213) reported HRQoL via Patient-Reported Outcomes Measurement Information System (PROMIS) surveys at baseline prior to cancer treatment and at 6-months and 24-months follow up from treatment initiation. Paraspinal intermuscular fat (IMF) and skeletal muscle (SM) were determined by magnetic resonance imaging, and the IMF:SM ratio was calculated to estimate muscle quality. Analyses included linear mixed-effects models adjusting for study group (placebo/statin), age, race, and body mass index. HRQoL declined from baseline to 6-months but returned to baseline levels by 24-months. Muscle quality worsened from baseline through 24-months manifested by an increase in IMF. Individuals with better muscle quality at baseline reported declines in HRQoL from baseline to 6-months (mean difference [MD] = − 0.12 ± 0.03, p < 0.001), whereas participants with poor baseline muscle quality did not (MD = − 0.06 ± 0.003, p = 0.14). An increase in IMF:SM over 24-months trended towards worse physical function (− 8.76 ± 5.79, p = 0.132). Muscle quality worsened over 24-months and trended toward worse physical function at 24-months follow-up. From initial declines during treatment, participants reported recovered HRQoL by 24-months. Further work in a larger cohort is needed to confirm associations with muscle quality and physical function.

Extant approaches to close the gap between implementation evidence and practice have been unsuccessful due in part to overreliance on researcher engagement. In practice, change is often driven by mid-level managers. We developed Context-Driven Co-Design (CD2) to equip mid-level managers with a theory- and evidence-based approach to implementation planning. We used a two-pronged design. First, we engaged six established implementation researchers in a modified Delphi process, involving two hour-long meetings and asynchronous feedback to develop and refine a CD2 prototype. Second, we piloted an in-person CD2 training and conducted an hour-long focus group to solicit feedback from mid-level managers on the potential value of CD2 for addressing implementation challenges and opportunities for improving the training. We incorporated focus group feedback and iteratively refined CD2 materials, codified each step of the approach, and further articulated CD2’s key features through two empirical applications. Delphi panelists unanimously agreed that prototype content would be best delivered through interactive training. The resulting one-time, three-hour in-person training was piloted with 17 mid-level managers affiliated with the National Cancer Institute Community Oncology Research Program who were often tasked with implementing cancer care delivery interventions and research protocols. Focus group participants (N = 5) appreciated the training’s practical tools, suggested that the training should focus on a common intervention, and requested more opportunities for peer learning before and after the training. CD2, further refined through subsequent empirical application, involves three steps: (1) agreeing upon an intervention to address a clinical problem and identifying the intervention’s effectiveness-driving features; (2) understanding the context in which the intervention will be implemented, including potential end-users, their workflows, and features of their environment; and (3) co-design session(s) to identify intervention adaptations, context modifications, and exogenous implementation strategies needed to facilitate the intervention’s implementation. We codified CD2, a theory-driven approach to harmonizing interventions, implementation contexts, and implementation strategies. Mid-level managers found CD2 to be an appropriate and acceptable approach to implementation planning. CD2 is consistent with perspectives that advocate humility and deference of researchers to individuals and contexts that biomedical research often positions as subjects. Future work is needed to enhance CD2’s feasibility and scalability.

e23181 Background: Health-related social needs (HRSN; i.e., health-harming conditions like food insecurity and housing instability) are often unaddressed among individuals with cancer, contributing to worse health outcomes. Although increasingly recognized as key to quality care delivery, HRSN screening may be challenging in low-resource community oncology settings. In this study (WF-2303CD), we sought to understand HRSN screening implementation in a national sample of clinics in the NCI Community Oncology Research Program (NCORP). Methods: This mixed methods observational study was conducted with the Wake Forest NCORP Research Base. We trained site staff to assess current HRSN screening processes and contextual factors influencing implementation using Context-Driven Co-Design methods, including a key informant interview and 3 hours of clinic observation per clinic. The study team analyzed interview transcripts and observation notes using template analysis to inform clinic classification based on HRSN screening implementation quality and comprehensiveness. Results: We assessed HRSN screening processes and factors influencing implementation in 41outpatient oncology clinics across 18 NCORP Community Sites. Preliminary results suggest wide implementation variation in the 37 clinics that self-reported HRSN screening. Most clinics reported using the NCCN Distress Thermometer (n = 16) or Epic SDOH Wheel (n = 9), while others relied on verbal screening or non-validated homegrown tools (n = 12). Further evaluation revealed few clinics had high-quality, systematic screening processes and even fewer had robust processes for following up on reported needs or needs reassessment. Identified implementation challenges included reliance on staff assumptions or patients raising concerns unprompted, processes reaching only a subset of patients (e.g., patients receiving infusions), or only focused on specific HRSN domain(s). Contextual factors identified as influencing HRSN screening are highlighted in Table 1. Conclusions: This is the first national, in-depth study of HRSN screening in community oncology settings. Findings illuminate the current capacity of diverse clinics to identify patients with unmet HRSN, screening tools and approaches in use, implementation gaps, and potential levers of change. These insights will inform future efforts to enhance HRSN screening in oncology. Contextual factors influencing HRSN screening implementation. Facilitators Barriers Leadership investment Accreditation process Staff perceptions of importance Integration of social work/navigation with primary care team Trust (patient-staff, staff-staff) Staff turnover Staff time constraints Need for multiple workflows to reach all patients Lack of awareness of community resources Challenges accessing HRSN responses from other settings

Sleep disturbances during breast cancer (BC) treatment may represent a modifiable contributor to left ventricular ejection fraction (LVEF) decline during BC treatment. We investigated the association of sleep disturbance and LVEF decline in a prospective cohort of 247 women with non-metastatic BC scheduled for chemotherapy as part of the UPBEAT study conducted through the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB; WF-97415, UG1CA189824). Participants completed cardiac magnetic resonance imaging to measure LVEF, six-minute walk distance, and validated surveys assessing sleep disturbance, physical health, and mental health at baseline and 3 months. Sleep disturbance was measured using the Patient Reported Outcomes Measurement Information System Sleep Disturbance survey. At 3-month follow-up, 30.3

Introduction Quitting smoking is challenging even with existing pharmacotherapy. Thus, discovery of new cessation medications is imperative. Memantine, a well-tolerated Alzheimer’s disease drug, partially antagonizes glutamate at the N-methyl-D-Aspartate receptor (NMDAR), modulating dopamine release in addiction pathways. Memantine may interrupt nicotine reward and promote smoking cessation. Materials and Methods At 23 community oncology practices nationwide, we recruited 130 breast, prostate, lung, or colorectal cancer survivors ≥ six months beyond definitive treatment who currently smoked at least 10 cigarettes daily and wanted to quit. In a double-blind fashion, participants were randomized to take either memantine (10 mg) or a matching placebo twice daily for 12 weeks (65 per arm). Toxicity, nicotine dependence, and past-week abstinence were recorded at 2, 4-, 6-, 9-, and 12-weeks post-randomization. The primary endpoint was feasibility and preliminary estimation of 12-week self-reported past-week smoking abstinence. Results There were no significant differences in abstinence rates or nicotine dependence between the two groups at 12 weeks. Twelve-week completion of therapy was low, but lower in memantine than control participants (42% vs 63%, respectively; P = .01). Memantine participants reported trends of less anxiety, craving, and hunger. No significant differences in toxicity were observed between groups. Serious adverse events (3 in memantine arm, 1 in control arm) occurred; none considered possibly or probably related to study medication. Conclusion Memantine did not improve 12-week smoking abstinence rates in cancer survivors. While other NMDAR antagonists might deserve evaluation, this study suggests memantine is not efficacious for smoking cessation in a cancer survivor subpopulation. Trial registration number NCT01535040 - February 17, 2012.

PURPOSE:Cancer-related cognitive impairment (CRCI) is a prevalent and persistent problem among many breast cancer survivors (BCS). Results from the randomized, placebo-controlled REMEMBER clinical trial (WF-97116) showed no improvement in cognitive test performance among BCS 1-5 years after chemotherapy after 24 weeks of daily donepezil compared with placebo. Here we present results for an important secondary outcome, patient-reported cognitive impairment, and explore the correlates of CRCI. PATIENTS AND METHODS:Women age ≥18 years with a history of breast cancer who completed ≥4 cycles of adjuvant cytotoxic chemotherapy 1-5 years before enrollment and self-reported CRCI were eligible. We enrolled participants through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base and randomly assigned participants to a 24-week course of once daily donepezil (single 5 mg dose titrated to 10 mg after 6 weeks) or placebo. We administered the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), a patient-reported outcome measure, at baseline and weeks 12, 24 (end of intervention), and 36 (wash-out). Mixed-effects repeated-measures analysis of covariance models assessed treatment differences in four FACT-Cog subscales. Additionally, demographic, clinical, and cognitive performance correlates of CRCI severity at baseline were examined. RESULTS:A total of 276 patients (mean age, 57.1; standard deviation, 10.5) from 87 NCORP sites were randomly assigned to donepezil (n = 140) or placebo (n = 136). There were no statistically significant treatment differences on the four CRCI outcomes: perceived cognitive impairments, cognitive abilities, impact on quality of life, and observations by others at 24 weeks. CRCI severity at baseline was associated with demographic variables, cognitive performance, and comorbidities, but not cancer-related variables. CONCLUSION:There were no discernible reductions in patient-reported CRCI attributable to donepezil, consistent with results for cognitive performance. CRCI severity appears to be multidimensional in nature, suggesting multifactorial prevention and treatment approaches might be beneficial.

Digital health tools are positive for delivering evidence-based care. However, few studies have applied rigorous frameworks to understand their use in community settings. This study aimed to identify implementation determinants of the Automated Heart-Health Assessment (AH-HA) tool within outpatient oncology settings as part of a hybrid effectiveness-implementation trial. A mixed-methods approach informed by the Consolidated Framework for Implementation Research (CFIR) examined barriers and facilitators to AH-HA implementation in four NCI Community Oncology Research Program (NCORP) practices participating in the WF-1804CD AH-HA trial. Provider surveys were analyzed using descriptive statistics. Interviews with providers (n = 15) were coded using deductive (CFIR) and inductive codes by trained analysts. The CFIR rating tool was used to rate each quote for (i) valence, defined as a positive (+) or negative (-) influence, and (ii) strength, defined as a neutral (0), weak (1), or strong (2) influence on implementation. All providers considered discussing cardiovascular health with patients as important (61.5%, n = 8/13) or somewhat important (38.5%, n = 5/13). The tool was well-received by providers and was feasible to use in routine care among cancer survivors. Providers felt the tool was acceptable and usable, had a relative advantage over routine care, and had the potential to generate benefits for patients. Common reasons clinicians reported not using AH-HA were (i) insufficient time and (ii) the tool interfering with workflow. Systematically identifying implementation determinants from this study will guide the broader dissemination of the AH-HA tool across clinical settings and inform implementation strategies for future scale-up hybrid trials.

Cancer survivors receiving doxorubicin may experience left ventricular ejection fraction (LVEF) decline during and following treatment; however, explanations for variations in decline beyond dosage differences, such as those related to socioeconomic status (SES), have not been fully examined. We conducted a retrospective analysis of a cohort of 215 breast cancer survivors receiving doxorubicin. SES factors (e.g., household income, education) were collected via a survey at a baseline and EF was assessed using magnetic resonance imaging. Linear regression models showed that prior to treatment, no SES factors were associated with LVEF. However, six months following treatment, survivors who were unemployed for reasons other than retirement and disability experienced greater LVEF declines compared to survivors who were employed ((b = 2.79 [95 Trial registration NCT01988571 (WF-98213).

BackgroundMost survivors of cancer have multiple cardiovascular risk factors, increasing their risk of poor cardiovascular and cancer outcomes. The Automated Heart-Health Assessment (AH-HA) tool is a novel electronic health record clinical decision support tool based on the American Heart Association’s Life’s Simple 7 cardiovascular health metrics to promote cardiovascular health assessment and discussion in outpatient oncology. Before proceeding to future implementation trials, it is critical to establish the acceptability of the tool among providers and survivors. ObjectiveThis study aims to assess provider and survivor acceptability of the AH-HA tool and provider training at practices randomized to the AH-HA tool arm within WF-1804CD. MethodsProviders (physicians, nurse practitioners, and physician assistants) completed a survey to assess the acceptability of the AH-HA training, immediately following training. Providers also completed surveys to assess AH-HA tool acceptability and potential sustainability. Tool acceptability was assessed after 30 patients were enrolled at the practice with both a survey developed for the study as well as with domains from the Unified Theory of Acceptance and Use of Technology survey (performance expectancy, effort expectancy, attitude toward using technology, and facilitating conditions). Semistructured interviews at the end of the study captured additional provider perceptions of the AH-HA tool. Posttreatment survivors (breast, prostate, colorectal, endometrial, and lymphomas) completed a survey to assess the acceptability of the AH-HA tool immediately after the designated study appointment. ResultsProviders (n=15) reported high overall acceptability of the AH-HA training (mean 5.8, SD 1.0) and tool (mean 5.5, SD 1.4); provider acceptability was also supported by the Unified Theory of Acceptance and Use of Technology scores (eg, effort expectancy: mean 5.6, SD 1.5). Qualitative data also supported provider acceptability of different aspects of the AH-HA tool (eg, “It helps focus the conversation and give the patient a visual of continuum of progress”). Providers were more favorable about using the AH-HA tool for posttreatment survivorship care. Enrolled survivors (n=245) were an average of 4.4 (SD 3.7) years posttreatment. Most survivors reported that they strongly agreed or agreed that they liked the AH-HA tool (n=231, 94.3%). A larger proportion of survivors with high health literacy strongly agreed or agreed that it was helpful to see their heart health score (n=161, 98.2%) compared to survivors with lower health literacy scores (n=68, 89.5%; P=.005). ConclusionsQuantitative surveys and qualitative interview data both demonstrate high acceptability of the AH-HA tool among both providers and survivors. Although most survivors found it helpful to see their heart health score, there may be room for improving communication with survivors who have lower health literacy. Trial RegistrationClinicalTrials.gov NCT03935282; http://clinicaltrials.gov/ct2/show/NCT03935282 International Registered Report Identifier (IRRID)RR2-https://doi-org.wake.idm.oclc.org/10.1016/j.conctc.2021.100808

12019 Background: Cardiovascular disease causes significant morbidity and mortality among US survivors. To enhance guideline recommended cardiovascular health (CVH) discussions during survivorship care, our team developed the EHR-based AH-HA clinical decision support tool, which displays modifiable CVH factors and cancer treatments with cardiotoxic potential. This tool significantly improved delivery of guideline-concordant CVH discussions, the primary study outcome; here we report AH-HA impacts on 12-month CVH improvements. Methods: The Wake Forest NCORP Research Base coordinated this practice-randomized clinical trial (NCT# 03935282) comparing AH-HA and usual care (UC) practices. Participants were survivors ≥ 6 months post-potentially curative treatment for breast, prostate, colorectal, endometrial cancers, or lymphoma, scheduled for routine follow-up. The AH-HA tool, based on the American Heart Association (AHA) Life’s Simple 7, aimed to enhance CVH awareness and action by providers and survivors. At AH-HA practices, providers used the tool with survivors during an outpatient oncology visit. CVH data were collected from the EHR and survivors (diet quality & physical activity) at baseline and 12 months. Outcomes included Simple 7 total CVH score (0-100, using AHA algorithm) and meaningful change in individual CVH factors (Table). Generalized estimating equations calculated rates of clinically meaningful improvements in CVH factors at 12 months by group, adjusting for cancer type and clustering within practice. Results: 645 survivors (82.3% breast cancer; 96.0% female; 83.9% white non-Hispanic, 7.8% Black, 3.7% Hispanic) enrolled at 9 practices (5 UC and 4 AH-HA). The total CVH score did not significantly change from baseline or between groups (Table 1, p>.05). Within the AH-HA arm, 20.3% of survivors achieved 5% weight reduction compared to 12.6% in UC; physical activity also improved more in the AH-HA arm, but not significantly. Rates were similar between arms for diet, blood pressure, and hemoglobin A1c. Conclusions: In addition to facilitating guideline concordant CVH discussions, AH-HA shows promise for encouraging weight loss among survivors. It is notable that a brief intervention delivered as part of standard oncology care impacted weight reduction. Clinical trial information: NCT03935282 . 12 month cardiovascular health outcomes among post-treatment survivors. CVH Outcomes AH-HA 4 practices, (n=281) Usual Care 5 practices, (n=342) Adj P-value Improvement, % Yes BMI (5% weight ↓) 20.3 12.6 0.02 Blood Pressure (5 mm ↓) 53.1 52.0 0.75 Physical Activity (+ 30 mins) 40.9 34.3 0.14 Healthy Diet Score (0-1 to 2-5, or 2-3 to 4-5 components) 21.7 18.9 0.45 Cholesterol (20% ↓) 8.6 9.6 # A1c (0.5% ↓) 8.9 8.8 0.97 Change in total CVH Score adjusted for baseline (positive=improvement) 0.9 -0.5 0.28 #Model did not converge due to small sample size.

PURPOSE:Post-treatment head and neck cancer (HNC) survivors experience multiple symptoms and behavioral health issues. We developed Head and Neck Survivorship Tool: Assessments and Recommendation (HN-STAR), a clinical decision support tool using electronic patient-reported outcomes (ePROs) to improve follow-up of HNC survivors. METHODS:We conducted a cluster-randomized controlled trial of oncology practices in the Wake Forest National Cancer Institute Community Oncology Research Program Research Base comparing HN-STAR to usual care (UC) during a routine clinic visit. Eligible survivors completed treatment for HNC < 2 years before. Before the visit, survivors completed ePROs rating the burden of 26 concerns (symptoms and health behaviors). During the visit, HN-STAR presented survivor's concerns and tailored clinician recommendations. After the visit, survivors reported which concerns were discussed. To evaluate differences in concerns discussed in clinic, concerns were characterized as absent or mild versus burdensome, with comparisons between arms for number of concerns discussed, number of burdensome concerns discussed, and proportion of burdensome concerns discussed, assessed by mixed models adjusted for within-practice correlation. RESULTS:Three hundred forty-nine survivors at 28 practices reported a previsit mean of 7.5 burdensome concerns (standard deviation, 4.6), most commonly xerostomia (70%), taste changes (53%), and neck or shoulder stiffness (48%). In adjusted models, survivors in the HN-STAR arm had more burdensome concerns discussed (4.1 v 3.3 concerns, P = .042) and a greater proportion of burdensome concerns discussed (57% v 44%, P = .015) at the visit than survivors in the UC arm. CONCLUSION:In a large, national, diverse, and symptomatic sample of HNC survivors at community oncology practices, using an ePRO-informed clinical decision support tool increased the likelihood that burdensome concerns were discussed in clinic. Alerting providers to burdensome concerns and presenting guideline-concordant management options at the point of care may improve provider-survivor interactions.

540 Background: Head and neck cancer survivors (HNCS) face high symptom burden and unmet health-related social needs (HRSN), yet few studies examine the co-occurrence of these issues. We investigated the association between HRSN and 4 commonly co-occurring symptoms (pain, fatigue, insomnia, emotional distress) among patients in HN-STAR, a site-randomized controlled trial of a web-based survivorship care tool. Methods: HN-STAR (NCT04208490) was conducted across 28 Wake Forest NCI Community Oncology Research Program practices. Participants were adult, disease-free HNCS, < 2 years post-treatment completion. At pre-intervention baseline, participants self-reported HRSN (housing, financial, transportation, and low health literacy) and symptoms. Housing, financial, and transportation needs were queried using the National Comprehensive Cancer Network Distress Thermometer (yes/no). Low health literacy was defined as ≤ “somewhat confident” completing medical forms. Four psychoneurological symptoms (pain, fatigue, insomnia, and distress) came from the EORTC QLQ-C30 and were scored using thresholds for clinical significance. The number of clinically significant symptoms was categorized as low (0-1) vs. moderate-high (2-4) symptom burden. We used a binomial generalized linear mixed model controlling for within-practice correlation to investigate associations between symptom burden and ≥1 HRSN along with demographic variables (age, sex, race/ethnicity). Stepwise selection identified the best-fitting model. Results: Of 351 HNCS (mean age 63.7 years; 76.1% non-Hispanic white; 76.6% male; 60.8% married/partnered), 135 (38.5%) experienced ≥1 HRSN and 121 (34.5%) had moderate-high symptom burden. The most common HRSNs were low health literacy (21.1%) and financial problems (19.1%). Pain (36.7%) and emotional distress (31.1%) were the most common clinically significant symptoms. In adjusted analyses, females vs. males (45% vs. 30%; OR 2.1 (95% CI (1.2, 3.6), p = 0.006) and those with ≥1 HRSN vs. none (45% vs. 27%; OR 2.3 (95% CI (1.4, 3.6), p < 0.001) had higher odds of moderate-high symptom burden. Conclusions: In a large, diverse, community-treated HNCS population experiencing a high degree of psychoneurological symptom burden and HRSN after treatment, females and those with ≥1 HRSN were more than twice as likely to experience moderate-high symptom burden. Addressing HRSN may improve symptom burden in this population. Clinical trial information: NCT04208490 .