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Context Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life; however, few interventions have been developed to enhance caregiver decision support skills. Objectives Assess the feasibility, acceptability, and potential efficacy of individual intervention components of CASCADE (CAre Supporters Coached to be Adept DEcision Partners), an early telehealth, palliative care coach-led decision support training intervention for caregivers. Methods Pilot factorial trial using the multiphase optimization strategy (October 2019-October 2020). Family caregivers and their care recipients with newly-diagnosed advanced cancer (n = 46 dyads) were randomized to1 of 8 experimental conditions that included a combination of one of the following three CASCADE components: 1) effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through postintervention interviews and participants’ ratings of their likelihood to recommend. Measures of effective decision support and caregiver and patient distress were collected at Twelve and Twenty four weeks. Results Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average caregiver ratings for recommending the program to others was 9.9 on a scale from 1-Not at all likely to 10-Extremely likely. Individual CASCADE components were observed to have potential benefit for effective decision support and caregiver distress. Conclusion We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers. A fully-powered factorial trial is warranted. Key Message We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer. CASCADE components were acceptable and the trial design feasible, providing promising future directions for palliative care intervention development and testing. Pilot results will inform a fully-powered trial.

Background Given the high risk of COVID‐19 mortality, patients with cancer may be vulnerable to fear of COVID‐19, adverse psychological outcomes, and health care delays. Methods This longitudinal study surveyed the pandemic's impact on patients with cancer (N= 1529) receiving Patient Advocate Foundation services during early and later pandemic. Generalized estimating equation with repeated measures was conducted to assess the effect of COVID‐19 on psychological distress. Logistic regression with repeated measures was used to assess the effect of COVID‐19 on any delays in accessing health care (e.g., specialty care doctors, laboratory, or diagnostic testing, etc.). Results Among 1199 respondents, 94% considered themselves high risk for COVID‐19. Respondents with more fear of COVID‐19 had a higher mean psychological distress score (10.21; 95% confidence intervals [CI] 9.38–11.03) compared to respondents with less fear (7.55; 95% CI 6.75–8.36). Additionally, 47% reported delaying care. Respondents with more fear of COVID‐19 had higher percentages of delayed care than those with less (56; 95% CI 39%–72% vs. 44%; 95% CI 28%–61%). These relationships persisted throughout the pandemic. For respondents with a COVID‐19 diagnosis in their household (n = 116), distress scores were similar despite higher delays in care (58% vs. 27%) than those without COVID‐19. Conclusions Fear of COVID‐19 is linked to psychological distress and delays in care among patients with cancer. Furthermore, those who are personally impacted see exacerbated cancer care delays. Timely psychosocial support and health care coordination are critical to meet increased care needs of patients with cancer during the COVID‐19 pandemic., Fear of COVID‐19 is associated with psychological distress and delay in cancer care. Timely psychosocial support and health care coordination are needed to meet increased care needs of patient with cancer during the pandemic.

BACKGROUND The healthy eating index-2015 (HEI-2015) reflects diet quality in reference to the 2015-2020 Dietary Guidelines for Americans (DGA). Little is known regarding its application in individuals with chronic spinal cord injury (SCI). OBJECTIVE To explore the relationship between diet quality as assessed by the HEI-2015 and cardiovascular risk factors among individuals with chronic SCI. DESIGN This is a cross-sectional analysis of baseline data collected from August 2017 through November 2019 for an interventional study that evaluates the effects of a high-protein/low-carbohydrate diet on cardiovascular risk factors in individuals with chronic SCI at the University of Alabama at Birmingham. PARTICIPANTS/SETTING Twenty-four free-living adults with SCI (mean age, 45 ± 12 y; 8F/16M, level of injury: nine cervical, 15 thoracic; mean duration of injury: 20 ± 13 y) were included. MAIN OUTCOME MEASURES Participants underwent a 2-hour oral glucose tolerance test (OGTT) and a dual-energy x-ray absorptiometry scan. Dietary intake was assessed by three, 24-hour multiple-pass dietary recalls to calculate the HEI-2015 using the simple HEI scoring algorithm method. DATA ANALYSIS Multiple linear regression analyses were performed to predict indices of lipid metabolism and glucose homeostasis and C-reactive protein (CRP) from the HEI-2015. Principal component analysis was used to reduce the number of covariates (level of injury, sex, and body fat percentage). RESULTS On average, participants' diets were of low quality (HEI-2015, 47.2 ± 10.8). The regression models for fasting glucose (FG), cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and CRP had moderate to large effect sizes (adjusted R2 ≥ 13%), suggesting good explanatory abilities of the predictors. Small or limited effect sizes were observed for glucose tolerance, fasting insulin, triglycerides, and Matsuda index (adjusted R2 < 13%). The HEI-2015 accounted for a moderate amount of variation in FG (partial omega-squared, ωP2 = 13%). Each 10-point HEI-2015 score increase was associated with a 3.3-mg/dL decrease in FG concentrations. The HEI-2015 accounted for a limited amount of variation in other indices (ωP2 < 5%). CONCLUSIONS Among participants with SCI, higher conformance to the 2015-2020 DGA was 1) moderately associated with better FG homeostasis; and 2) trivially associated with other cardiovascular risk factors. Because of the small sample size, these conclusions cannot be extrapolated beyond the study sample. Future larger studies are warranted to better understand the relationship between diet quality and cardiovascular disease risks in this population.

PURPOSE: The extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. METHODS: This retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race/ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011–2020. Odds ratios (OR) from a logistic regression model was used to evaluate the association between receipt of high-intensity chemotherapy and clinical trial representation status characteristics adjusting for cancer stage and subtype. RESULTS: Of 970 patients with EBC, 41% were characterized as well represented, 45% as underrepresented, and 13% as unrepresented in clinical trials. In adjusted models, patients aged ≥ 70 versus 45–69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26–0.60), while those aged < 45 versus 45–69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10–3.01). In predicted estimates, the proportion of patients receiving a high-intensity treatment was 87% for patients aged < 45, 79% for patients aged 45–69, and 60% for patients aged ≥ 70. CONCLUSION: 59% of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity. Widening clinical trial eligibility criteria should be considered to better understand survival outcomes, toxicity effects, and ultimately make evidence-based treatment decisions using a more diverse sample.

Though lay navigation programs have proven beneficial for individuals during cancer treatment, little is known about the effects of lay navigation on health care utilization and Medicare spending among older adults during cancer survivorship. This retrospective cohort study used administrative claims data to evaluate a lay navigation program implemented from 2012 to 2015 at 12 academic and community cancer centers in the Southeast. Medicare beneficiaries age ≥65 years navigated during survivorship were compared to propensity score–matched, non-navigated cancer survivors. Quarterly trends in Medicare spending were estimated using repeated measures mixed models. Rate ratios (RRs) and 95% confidence intervals (CIs) were estimated using repeated measures generalized linear models for quarterly emergency room (ER) visits and hospitalizations. Medicare spending for navigated (n = 3255) versus non-navigated older cancer survivors (n = 3255) was initially higher but declined faster by $513 per patient per quarter (95% CI −$616, −$410). Per patient per quarter risk of ER visits decreased by 11% (RR 0.89, 95% CI 0.86, 0.92) and hospitalizations decreased by 16% (RR 0.84, 95% CI 0.81, 0.88) over time comparing navigated versus non-navigated patients. Similar results were seen for patients enrolled in navigation post-treatment (N = 1893). In older cancer survivors receiving care in the Deep South, patients receiving lay navigation compared to those non-navigated had significant reductions in Medicare spending, hospitalizations, and ER visits. Though much emphasis has been placed on lay navigation during initial cancer treatment, navigation is needed throughout survivorship due to the high costs and health care utilization that persist post-treatment.

Half of people with HIV (PWH) have HIV-associated neurocognitive disorder (HAND). This study examined whether cognition can be improved using a framework targeting impaired individual cognitive domains in PWH with HAND. In this two-group pre-post experimental design study, 88 adults with HAND were randomized to either: (1) a no-contact control group (n = 40) or (2) the Individualized-Targeted Cognitive Training group (n = 48). Baseline cognitive performance was assessed on eight cognitive domains. A theoretical framework was used to determine the two cognitive domains selected for training. With priority on speed of processing (SOP) and attention impairments, participants received SOP and/or attention training if such impairments were detected; if not, participants were assigned to cognitive training in one/two of the least impaired cognitive domains contributing to their HAND diagnosis. Global cognitive score was slightly improved following training (p = 0.256; d = − 0.21), but it was not significant. Significant improvements were observed on SOP following training in that domain (SOP; d = − 0.88; p = 0.011). SOP training also improved functioning in other cognitive domains. This individualized cognitive intervention did not change HAND status, but it did result in improved SOP, in turn yielding improvement in other cognitive domains.

PURPOSE Sequential drug treatments in metastatic breast cancer (MBC) are disparate. Clinical trial data includes limited reporting of treatment context, primarily including the number of prior therapies. This study evaluates the relationship between prior treatment time, prior lines of treatment, and survival using a novel visualization technique coupled with statistical analyses. PATIENTS AND METHODS This retrospective cohort study used a nationwide, de-identified electronic health record–derived database to identify women with hormone receptor–positive, human epidermal growth factor receptor 2–negative MBC diagnosed in 2014 who subsequently received paclitaxel. Images were created, with individual patients represented on the y-axis and time, on the x-axis. Specific treatments were represented by colored bars, with Kaplan-Meier curves overlaying the image. Separate images assessed progression-free survival and overall survival (OS). Hazard ratios (HRs) and 95% CIs from Cox proportional hazards models evaluated the association between prior treatment time and OS. RESULTS Of 234 patients, median survival from first paclitaxel administration was 20 months (interquartile range, 8-53 months). An inverse relationship was observed between OS after paclitaxel and timing of administration. In adjusted models, each year on treatment prior to paclitaxel was associated with a 16% increased hazard of death after paclitaxel (HR, 1.16; 95% CI, 1.05 to 1.29). CONCLUSION OS after a specific treatment is dependent on when a drug is given in the disease context, highlighting the potential for an overall OS benefit to be observed on the basis of treatment timing. Prior time on treatment should be considered as a stratifying factor in randomized trials and a confounding factor when examining survival in observational data.

PURPOSE Treatment sequencing of metastatic breast cancer (MBC) is heterogeneous. The primary objective of this study was to develop a visualization technique to understand population-level treatment sequencing for MBC. Secondary outcomes were to describe the heterogeneity of MBC treatment sequencing, as measured by the proportion of patients with a rare sequence, and to generate hypotheses about the impact of sequencing on overall survival. METHODS This retrospective review evaluated treatment sequencing for patients with MBC in the SEER–Medicare database. Patients with either de novo MBC or International Classification of Diseases, Ninth Revision, diagnosis codes for secondary metastasis (197.XX-198.XX) on two separate dates, excluding breast (198.81, 198.82, 198.2) and lymph nodes (196.XX), were included. Complete Medicare Parts A, B, and D coverage was required. A treatment sequence that fewer than 11 patients received was considered rare. A graphic was created with each nonrare treatment-sequence grouping on the y-axis and time on the x-axis. Bars representing time on hormonal therapy, chemotherapy, human epidermal growth factor receptor 2–targeted therapy, and other targeted therapies were color coded. Kaplan-Meier–like curves were overlaid on treatment maps, using estimated median survival for each sequence. RESULTS Of 6,639 patients with MBC, 56% received a treatment sequence that fewer than 11 other patients received, with 2,985 other unique, rare sequences were identified. Sequence visualization demonstrated differential survival, with longer median survival for those initially receiving hormonal therapy. The median time receiving initial treatment was similar for patients receiving first-line chemotherapy. CONCLUSION Treatment-sequence visualization can enhance the capacity to effectively conceptualize treatment patterns and patient outcomes.

Background Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life‐limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment‐related decision‐making. Methods Estimates of time spent receiving cancer‐related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time‐in‐motion quality improvement evaluation (process mapping); (b) cross‐sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). Results Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. Conclusion Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method., In patients with metastatic breast cancer, time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on type of treatment received and its administration method. The greatest time contributions were time spent traveling for care and on inpatient services, and health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents.

Background Every one out of 10 nurses reported suffering from high levels of burnout worldwide. It is unclear if burnout affects job performance, and in turn, impairs patient safety, including medication safety. The purpose of this study is to determine whether nurse burnout predicts self-reported medication administration errors (MAEs). Methods A cross-sectional study using electronic surveys was conducted from July 2018 through January 2019, using the Copenhagen Burnout Inventory. Staff registered nurses (N = 928) in acute care Alabama hospitals (N = 42) were included in this study. Descriptive statistics, correlational, and multilevel mixed-modeling analyses were examined. Results All burnout dimensions (Personal, Work-related, and Client-related Burnout) were significantly correlated with age (r = -0.17 to -0.21), years in nursing (r = -0.10 to -0.17), years of hospital work (r = -0.07 to -0.10), and work environment (r = -0.24 to -0.57). The average number of self-reported MAEs in the last 3 months was 2.13. Each burnout dimension was a statistically significant predictor of self-reported MAEs (p Conclusions Nurse burnout is a significant factor in predicting MAEs. This study provides important baseline data for actionable interventions to improve nursing care delivery, and ultimately health care, for Alabamians.

PURPOSE: In patients with metastatic breast cancer (MBC), low health insurance literacy may be associated with adverse material conditions, psychological response, and coping behaviors because of financial hardship (FH). This study explored the relationship between health insurance literacy and FH in women with MBC. METHODS: This cross-sectional study used data collected from 84 women receiving MBC treatment at 2 southeastern cancer centers. Low health insurance literacy was defined as not knowing premium or deductible costs. FH was defined by lifestyle changes as a result of medical expenses, financial toxicity, and medical care modifications attributable to cost. Mean differences were calculated using Cramer’s V. Associations between health insurance literacy and FH were estimated with adjusted linear models. RESULTS: Half of the surveyed patients had low health insurance literacy, 26% were underinsured, 45% had private insurance, 39% had Medicare, and 15% had Medicaid. Patients with low health insurance literacy more often reported borrowing money (19% v 4%; V = 0.35); an inability to pay for basic necessities like food, heat, or rent (10% v 4%; V = 0.18); and skipping a procedure (8% v 1%; V = 0.21), medical test (7% v 0%; V = 0.30), or treatment (4% v 0%; V = 0.20) compared with patients with high health insurance literacy. Median Comprehensive Score for Financial Toxicity was 23 (interquartile range, 17-29). In adjusted models, health insurance literacy was not associated with financial toxicity. CONCLUSION: Low health insurance literacy was common in women receiving MBC treatment. Additional research to increase health insurance literacy could lessen undesirable material FH and unnecessary behavioral FH associated with cancer-related care.

Background: Sequential therapeutic options in metastatic breast cancer (MBC) are disparate. However, clinical trial data on treatments received pre- or post-trial are limited to number of prior therapies and not the prior sequence or duration of treatment. The lack of contextual data on prior treatment history in clinical trials may contribute to challenges evaluating efficacy. This study sought to understand the relationship between sequential order of treatments, prior treatment time, and survival using a novel visualization technique and conventional statistics. Methods: This retrospective cohort study utilized the nationwide, de-identified electronic health record (EHR)-derived Flatiron Health database to identify women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) -negative MBC diagnosed in 2014 who subsequently received paclitaxel. Visualizations were created with individual patients represented on the Y-axis and time on the X-axis to qualitatively evaluate treatment patterns and survival. Time 0 was defined as initiation of paclitaxel in the metastatic setting. Specific treatments were represented by a color-coded treatment bar, with post-metastatic paclitaxel in black, hormonal therapy in shades of red, chemotherapy in shades of blue, HER2-targeted therapy in shades of green, and other targeted therapies in shades of orange. Treatment gaps were represented by white space. A Kaplan-Meier curve was generated as a function of time from paclitaxel to death or censoring and was superimposed on the visualization. Separate visualizations assessed progression-free and overall survival (PFS, OS). Hazard ratios (HR) and 95% confidence intervals (CI) from Cox proportional hazard models evaluated the association between prior treatment time and post-paclitaxel OS. Results: Of 877 ER+/HER2- MBC patients diagnosed in 2014, 234 received paclitaxel. Qualitatively, the visualization graphic sorted by OS demonstrated that patients who received treatments for longer durations prior to paclitaxel had worse survival compared to those who received paclitaxel earlier in their treatment course (i.e., shorter time on treatment prior to receiving paclitaxel). Quantitatively, median survival from paclitaxel initiation was 20 months (IQR 8-53). When dividing the sample into quartiles based on overall survival after paclitaxel, median time on treatment prior to paclitaxel was 2 months (IQR 0.3-7), 8 months (1-31 IQR), 10 (1-28) months (IQR), and 11 months (IQR 3-32; Table 2). In adjusted models, every year increase on treatment prior to paclitaxel initiation was associated with a 16% increased yearly hazard of death (HR 1.16, 95% CI 1.05-1.29). Conclusion: Visualizing paclitaxel in the context of disease course demonstrates an association between length of time on prior therapy and remaining OS, highlighting the potential for an overall OS benefit to be observed merely based on early vs. late receipt of treatment. This approach to graphically visualizing treatment sequences can aid in better understanding treatment patterns and their impact on survival outcomes through the power of patient-level data. This study should promote future evaluation of treatment sequencing and duration of prior therapies when studying the impact of new treatments, which will be perpetually important as new FDA-approved medications are incorporated into existing MBC treatment paradigms. Citation Format: Gabrielle Rocque, Aidan Gilbert, Courtney P Williams, Arie Nakhmani, Pravinkumar G Kandhare, Andres Azuero, Smita Bhatia, Kelly M Kenzik, Mark E Burkard. Visualization of the relationship between survival and sequential treatments in metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-05.

Background Little is known about the prevalence of healthy lifestyle (HLS) discussions between providers and older cancer survivors. Methods We utilized cross‐sectional data from older cancer survivors (≥65 years) seen at 12 southeastern cancer centers during 2013‐2015. Data on demographics, time since diagnosis, weight, height, and healthy behaviors were collected. Respondents were asked if providers (oncologists, other physicians, and/or nurses) discussed exercise, healthy diet, weight management, and/or smoking cessation during clinical encounters. Descriptive statistics and bivariate associations between HLS topics and survivor characteristics were calculated. Results Among 1460 cancer survivors, mean age was 74 years (SD 6), most were white (81%), and >1 year postdiagnosis (84%). The majority (71%) reported discussing at least one of three HLS topics (exercise 49%, healthy diet 53%, vegetable consumption 28%); 17% received counseling on all three. Weight loss was recommended to 33% of overweight/obese survivors and smoking cessation to 85% of current smokers. Oncologists and nurses discussed HLS less frequently compared to other physicians. Younger survivors (65‐74 years) received recommendations for exercise, weight loss, and tobacco cessation more often than older survivors (≥75 years). Compared to white respondents, minorities reported discussions on all topics more often except for tobacco cessation. Excluding tobacco cessation, survivors with recent cancer diagnoses (1 year postdiagnosis. Conclusion Despite the American Cancer Society's recommendations, older survivors reported a low prevalence of HLS discussions with their providers, with some variation by demographic groups. Strategies are needed to promote these important discussions in this population., Provider's recommendations for weight management, healthy diet, physical activity, and smoking cessation are key in promoting healthy lifestyles (HLS) among older cancer survivors. However, we found that not all survivors discuss all relevant HLS with their providers, with some groups of survivors having these discussions less often than others. Additional studies and strategies are needed to promote HLS discussions and achieve the American Cancer Society's (ACS) recommended HLS goals especially for diet, weight, and physical activity among older cancer survivors in the Southeastern US healthcare system

Although CDC guidelines call for universal, "opt-out" HIV testing, barriers to testing continue to exist throughout the United States, with the rural South particularly vulnerable to both HIV infection and decreased awareness of status. Therefore, the objectives of this study were to evaluate uptake of "opt-out" HIV testing and barriers to testing within the primary care setting in the South. A concurrent triangulation design guided the collection of quantitative data from patients (N = 250) and qualitative data from providers (N = 10) across three primary health clinics in Alabama. We found that 30% of patients had never been tested for HIV, with the highest ranked barrier among patients being perceived costs, access to specialty care, and not feeling at risk. Significant differences existed in perceived barriers between patients and providers. Increased provider-patient engagement and the routine implementation of "opt-out" HIV testing would effectively reveal and mitigate barriers to testing, thus, increasing awareness of status.

Background: Improving family caregiver preparation for surrogate decision making is a critical priority. Objective: Determine a parsimonious set of intrapersonal factors associated with family caregivers' confidence in making future medical decisions for their relatives with cancer. Methods: Cross-sectional mail survey. Family caregivers of Medicare beneficiaries with pancreatic, lung, brain, ovarian, head and neck, hematologic, and stage IV cancers from communities of eight U.S. cancer centers. Participants completed validated measures of their social and mental health, self-care behaviors, coping styles, and surrogate decision-making confidence. Using linear modeling, the Bayesian information criterion was used to identify factors associated with decision-making confidence. A bootstrap approach was used to conduct penalized inference on the selected model coefficients. Model fit validation was assessed with a random forest ensemble. Results: Caregivers (n = 294) were on average 65.5 years old, mostly female (72.8%), and care recipients' spouse/partner (60.2%). The parsimonious set of factors associated with low caregiver decision-making confidence included less engagement in spiritual growth self-care, more use of avoidant coping, low emotional social support, and younger care recipient age (in-sample R(2) = 0.22). These factors were also identified by a random forest approach. After overfitting adjustment (shrunken R(2) = 0.09), the strongest associations with low surrogate decision-making confidence were low spiritual growth self-care (adjusted standardized B = 0.17, p = 0.005) and high use of avoidant coping (adjusted standardized B = −0.12, p = 0.049). Discussion: Identifying strategies to enhance spiritual growth and reduce avoidant coping may be promising targets for interventions to improve family caregivers' confidence in future surrogate decision making.

CONTEXT: Research priority guidelines highlight the need for examining the “dose” components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the “dose” effect of PC intervention completion vs. non-completion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. ‘Completers’ defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. ‘Non-completers’ were defined as either not attending the OPCC or completing < 6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for ‘completers’ vs ‘non-completers’ over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as ‘completers’ with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. ‘Completers’ vs. ‘non-completers’ groups were well-balanced at baseline; however ‘non-completers’ did report higher anxiety (6.0 vs 7.0, p

Importance National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered “fairly good” quality of life; and the Functional Assessment of Chronic Illness Therapy–Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7;d = 0.07 [95% CI, −0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8;d = 0.12 [95% CI, −0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety,d = −0.02 [95% CI, –0.20 to 0.16]; HADS-depression,d = –0.09 [95% CI, –0.24 to 0.06]). Conclusions and Relevance This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

Women living with HIV are disproportionally affected by depression and mental healthcare access. A pilot feasibility trial using videoconferencing compared cognitive behavioral therapy for antiretroviral therapy adherence and depression ( N = 11) to supportive psychotherapy ( N = 11). Participants completed 10–12 weekly therapy sessions and 6-month follow-up. Retention at 6 months was 95 percent. Depression symptoms significantly decreased in both arms; antiretroviral therapy adherence remained high as measured via self-report and Wisepill. Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling. This study demonstrates the feasibility of telemedicine-administered psychotherapy addressing mental health needs among women living with HIV.

PURPOSE: To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS) in which education was delivered early or after the support component. METHODS: Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S), and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study - Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods. RESULTS: Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (Mean (Standard deviation): SF-36 PCS: 44.88 (10.6) vs. 45.08 (10.6) ; MCS: 49.45 (11.1) vs. 48.1 (11.9); CES-D: 10.11 (9.8) vs. 10.86 (10.5) ; POMS-SF: 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS: 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen’s d −0.22, 95% CI: −0.38, −0.06) and POMS (Cohen’s d 0.23, 95% CI: 0.07, 0.39) for EE-S vs. S-DE. CONCLUSIONS: The implementation strategies were equivalent. IMPLICATIONS FOR SURVIVORS: Enhancing support may be considered before delivering not-in-person interventions to RBCS.

Background Preterm birth is a risk factor for elevated blood pressure in childhood and the development of hypertension and cardiometabolic disease in adulthood; however, mechanisms for the development of both are poorly understood. Rapid weight gain early in childhood may serve as a driver directly and indirectly through cortisol levels found to be elevated in early childhood in individuals born preterm. Objectives The objective of this pilot study was to examine the effect sizes of the relationships between weight gain and blood pressure in toddlers born very preterm. A secondary aim was to note any mediating effect of cortisol on the relationships between weight gain and blood pressure. Methods A cross-sectional design with a convenience sample of 36 toddlers who were born very preterm was used to examine the relationships between postnatal weight gain, cortisol, and blood pressure at follow-up. Results Many of the participants experienced rapid weight gain in the first 12 months of life. Mean systolic and diastolic readings were 94 and 56.6, respectively. Diastolic blood pressure readings were obtained from 23 participants, and the majority were elevated. Weight gain was associated with diastolic blood pressure with a medium effect size. A mediating role with cortisol was not supported. Discussion Although findings need to be validated in a larger sample, the blood pressure elevations in this sample were alarming. If readings continue to amplify as these children age, the fact that elevations are already present during the toddler period could indicate more significant cardiovascular disease in adulthood for this population. Rapid weight gain in early life may be a driver for elevated blood pressure even during early childhood in individuals born preterm.

BACKGROUND The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

Background National Comprehensive Cancer Network (NCCN) guideline-based treatment is a marker of high-quality care. The impact of guideline discordance on cost and health care utilization is unclear. Materials and Methods This retrospective cohort study of Medicare claims data from 2012 to 2015 included women age ≥65 with stage I–III breast cancer receiving care within the University of Alabama at Birmingham Cancer Community Network. Concordance with NCCN guidelines was assessed for treatment regimens. Costs to Medicare and health care utilization were identified from start of cancer treatment until death or available follow-up. Adjusted monthly cost and utilization rates were estimated using linear mixed effect and generalized linear models. Results Of 1,177 patients, 16% received guideline-discordant treatment, which was associated with nonwhite race, estrogen receptor/progesterone receptor negative, human epidermal growth receptor 2 (HER2) positive, and later-stage cancer. Discordant therapy was primarily related to reduced-intensity treatments (single-agent chemotherapy, HER2-targeted therapy without chemotherapy, bevacizumab without chemotherapy, platinum combinations without anthracyclines). In adjusted models, average monthly costs for guideline-discordant patients were $936 higher compared with concordant (95% confidence limits $611, $1,260). For guideline-discordant patients, adjusted rates of emergency department visits and hospitalizations per thousand observations were 25% higher (49.9 vs. 39.9) and 19% higher (24.0 vs. 20.1) per month than concordant patients, respectively. Conclusion One in six patients with early-stage breast cancer received guideline-discordant care, predominantly related to undertreatment, which was associated with higher costs and rates of health care utilization. Additional randomized trials are needed to test lower-toxicity regimens and guide clinicians in treatment for older breast cancer patients. Implications for Practice Previous studies lack details about types of deviations from chemotherapy guidelines that occur in older early-stage breast cancer patients. Understanding the patterns of guideline discordance and its impact on patient outcomes will be particularly important for these patients. This study found 16% received guideline-discordant care, predominantly related to reduced intensity treatment and associated with higher costs and rates of health care utilization. Increasing older adult participation in clinical trials should be a priority in order to fill the knowledge gap about how to treat older, less fit patients with breast cancer.

Background Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). Methods/Design The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. Discussion This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. Trial registration ClinicalTrials.gov, NCT02505425. Registered on 22 July 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2770-9) contains supplementary material, which is available to authorized users.

Objectives The purpose of this study was to test the efficacy of MOUTh (Managing Oral Hygiene Using Threat Reduction), a nonpharmacologic, relationship-based intervention vs. control on 2 primary outcomes for nursing home (NH) residents with dementia who resisted mouth care: (i) reduction in the occurrence and intensity of care-resistant behaviours (CRBs) and (ii) improvement in oral health. Two secondary outcomes were also examined: (i) the duration of mouth care and (ii) the completion of oral hygiene activities. Background Persons with dementia who exhibit CRBs are at risk for inadequate mouth care and subsequent systemic illnesses. Materials and methods The study used a randomised repeated measures design. Recruitment occurred in 9 nursing homes that varied in size, ownership, reimbursement patterns and location. One hundred and one nursing home residents with dementia were randomised at the individual level to experimental (n = 55) or control groups (n = 46). One hundred participants provided data for the analyses. Results Compared to the control group, persons in the experimental group had twice the odds of allowing mouth care and completing oral hygiene activities; they also allowed longer duration of mouth care (d = 0.56), but showed only small reductions in the intensity of CRBs (d = 0.16) and small differential improvements in oral health (d = 0.18). Conclusion The data suggest that this intervention facilitates mouth care among persons with dementia. The management of refusal behaviour may be a clinically more realistic approach than reducing or eradicating refusals.

Purpose: The Oncology Care Model (OCM) is a highly controversial specialty care model developed by the Centers for Medicare & Medicaid aimed to provide higher-quality care at lower cost. Because oncologists will be increasingly held accountable for spending as well as quality within new value-based health care models like the OCM, they need to understand the drivers of total spending for their patients. Methods: This retrospective cohort study included patients ≥ 65 years of age with primary fee-for-service Medicare insurance who received antineoplastic therapy at 12 cancer centers in the Southeast from 2012 to 2014. Medicare administrative claims data were used to identify health care spending during the prechemotherapy period (from cancer diagnosis to antineoplastic therapy initiation) and during the OCM episodes of care triggered by antineoplastic treatment. Total health care spending per episode includes all types of services received by a patient, including nononcology services. Spending was further characterized by type of service. Results: Average total health care spending in the three OCM episodes of care was $33,838 (n = 3,427), $23,811 (n = 1,207), and $19,241 (n = 678). Antineoplastic drugs accounted for 27%, 32%, and 36% of total health care spending in the first, second, and third episodes. Ten drugs, used by 31% of patients, contributed 61% to drug spending ($18.8 million) in the first episode. Inpatient spending also substantially contributed to total costs, representing 17% to 20% ($30.5 million) of total health care spending. Conclusion: Health care spending was heavily driven by both antineoplastic drugs and hospital use. Oncologists’ ability to affect these types of spending will determine their success under alternative payment models.

Background: Symptom burden has a negative impact on Health-Related Quality of Life (HRQoL). Identifying symptom burden and sources utilized for symptom management at different points in the cancer trajectory may guide development of supportive care services for older patients with breast cancer. Methods: This was secondary analysis of survey data from the University of Alabama at Birmingham Health System Cancer Community Network, which includes 12 hospitals across the Southeast. Female Medicare beneficiaries with breast cancer were surveyed from 2013-2015 via telephone. Demographic information, treatment status, HRQoL (Short Form Health Survey, SF-12), symptom burden (MD Anderson Symptom Inventory, MDASI), and sources used for symptom management (e.g. doctors, nurses) were collected. Descriptive statistics were computed for all variables of interest. HRQoL, overall symptom burden, and individual symptom scores by treatment status were compared using standardized mean differences (Cohen's d) and Student's t-tests. Simple linear regression was used to determine the association between symptom burden and HRQoL scores. A 10% False-Discovery-Rate was used to adjust for multiple inference. Results: 321 women age 65 years and older with breast cancer were included in the survey sample; 141 (45%) were on treatment with chemotherapy (9%), radiation (1%), recurrence treatment (6%), or other planned cancer treatment (29%). Similar HRQoL scores were observed for participants on and off treatment, with SF-12 physical scores of 39.2 (SD 11.5) vs. 41.4 (SD 11.9, d=.19) and SF-12 mental scores of 52.5 (SD 9.7) vs. 53.2 (SD 9.4, d=.07). Symptom burden was also similar, with overall MDASI severity scores of 2.5 (SD 1.9) and 2.2 (SD 1.7, d=.17). For participants on treatment, fatigue and disturbed sleep were the most severe symptoms with average scores of 4.4 (SD 3.0) and 3.6 (SD 3.2), respectively. For participants off treatment, the most severe symptoms were fatigue and memory problems with average scores of 3.8 (SD 3.1) and 3.1 (SD 2.7). A small difference in disturbed sleep was observed, with participants on treatment reporting more symptom severity (3.6 [SD 3.2] vs 2.7 [SD 2.9], d=.3, p=.01). Minor differences were observed for the severity of other specific symptoms between the groups. For patients both on and off treatment, MDASI scores were strongly and significantly associated with decreased SF-12 physical (on: β=-3.0 [SE 0.4], R2=.21, p Conclusion: Quality of life and overall symptom burden were similar for patients on and off treatment, with only a small difference in disturbed sleep. Overall symptom burden was strongly associated with decreased HRQoL among older females with breast cancer. Nurses were the most common source utilized for symptom management, suggesting the importance of systematic trainings, particularly for nurses, on symptom management and supportive care services for patients on and beyond treatment. Citation Format: Halilova KI, Williams CP, Azuero A, Kvale EA, Yagnik SK, Goertz H-P, Pizu M, Rocque GB. Health-related quality of life, symptom burden and management in older women with breast cancer across the illness trajectory [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-12.

75 Background: Many patient population groups are not proportionally represented in clinical trials, including patients of color, at age extremes, or with comorbidities. It is unclear how treatment outcomes may differ for these patients compared to those well represented in trials. Methods: This retrospective cohort study included women diagnosed with early-stage (I-III) breast cancer (EBC) between 2005-2015 in the CancerLinQ Discovery electronic medical record-based dataset. Patients with comorbidities or concurrent cancer were considered unrepresented in clinical trials. Non-White patients and/or those aged

152 Background: Given the high risk of COVID-19 mortality, patients with cancer are not only vulnerable to physical consequences of COVID-19 infection, but also to adverse psychological outcomes, including fear of COVID-19. Without intervention, psychological distress in patients with cancer can lead to worsening symptoms, poor quality of life, and lower survival. We sought to evaluate the association between fear of COVID-19 and psychological distress for under-resourced patients with cancer during the pandemic. Methods: This observational, longitudinal survey study, fielded during early (May 20- July 11, 2020) and later pandemic (December 2-December 23, 2020), evaluated the pandemic’s impact on patients with cancer receiving Patient Advocate Foundation (PAF) services from July 2019 – April 2020. Questions focused on individual experiences with COVID-19 and psychological, emotional, physical, and material effects from the pandemic. The validated Fear of COVID-19 Scale was used to determine fear of COVID-19. Psychological distress was determined using a four-item questionnaire by Holingue et al. (score range 4 – 16). Means and 95% confidence intervals (CI) were estimated using generalized estimating equation modeling with repeated measures to assess the effect of fear of COVID-19 on psychological distress early and later in the pandemic. Models adjusted for age, sex, race/ethnicity, region, annual household income, household size, marital status, employment status, Area Deprivation Index category, Rural-Urban Commuting Code category, cases per 100,000 in county of residence, cancer type, and number of comorbidities. Results: Amongst 1199 survey respondents, 94% considered themselves high risk for COVID-19. 448 respondents completed both the first and second survey. The majority of respondents were female (72%) and age 56-75 (55%); 40% were Black, Indigenous, or Persons of Color. In adjusted models of respondents who completed the early pandemic survey, respondents with more fear of COVID-19 had a higher mean psychological distress score (10.21; 95% CI 9.38-11.03) compared to respondents with less fear (7.55; 95% CI 6.75-8.36). Among those who completed the later pandemic survey, median fear of COVID-19 decreased (20 vs 19)median distress scores remained the same (8); respondents with more fear of COVID-19 had a higher mean psychological distress score (9.98; 95%CI 9.04-10.92) compared to respondents with less fear (7.87; 95%CI 6.98-8.76). Conclusions: Fear of COVID-19 was linked to psychological distress and persisted throughout the pandemic among under-resourced patients with cancer. Timely psychosocial support is critical to meet increased care needs experienced by patients with cancer during the COVID-19 pandemic. Given these results, fear of COVID-19 could be considered as a trigger to integrate psychological interventions in patients with cancer to treat psychological distress.

148 Background: The World Health Organization cited vaccine hesitancy as one of 2019’s top ten threats to global health, a threat that has been further exacerbated by COVID-19 pandemic. Existing COVID-19 vaccine hesitancy research focuses on the general population, but less is known about the specific concerns of medically vulnerable populations, including individuals with cancer. Methods: This cross-sectional analysis used data that assessed likelihood of COVID-19 vaccination (likely vs unlikely/unsure) among past or current patients with cancer from a nationwide survey administered in December 2020 by the Patient Advocate Foundation (PAF), a non-profit organization that provides case management and financial aid to patients diagnosed with a chronic illness. Inclusion criteria included previous or current cancer treatment, aged ≥ 19, and a valid e-mail address. Age, sex, race/ethnicity, and urban/rural residence were abstracted from the PAF database. Respondents self-reported education level, employment status, trust in media regarding COVID-19 pandemic, and media viewership on COVID-19 vaccine development. The Group-Based Medical Mistrust Scale assessed respondents’ level of mistrust in medical providers based on ethnicity. Likelihood of COVID-19 vaccine acceptance was evaluated using risk ratios (RR) and 95% confidence intervals (CI) from modified Poisson regression models with robust error variance. All variables were included in our model. Results: Of 429 respondents, 48% were unlikely/unsure about accepting the COVID-19 vaccine, primarily due to concerns about vaccine safety (32%) and worry about health conditions (12%). When compared to those likely to accept COVID-19 vaccine, respondents who were unlikely/unsure were more often Black, Indigenous, or People of Color (40% vs. 23%), aged 36-55 (40% vs. 29%), and female (80% vs. 65%). In adjusted analysis, Black respondents were 55% less likely to accept a COVID-19 vaccine, when compared to White respondents (RR 0.55; 95% CI 0.4-0.8). When compared to those who did not follow the media regarding COVID-19 vaccine development, those who followed the media very closely were 4.5 times more likely to accept a COVID-19 vaccine (RR 4.5; 95% CI 1.6-13.2). Respondents who reported below average trust in the media were 60% less likely to accept a COVID-19 vaccine (RR 0.6; 95% CI 0.5-0.8), compared to those who reported above average trust in the media. Conclusions: Despite being at high risk of COVID-19 morbidity and mortality, a substantial proportion of under-resourced individuals with cancer were unlikely/unsure about vaccination, exposing a significant disconnect between risk of severe disease and vaccine acceptance. Our analysis also reveals a need to assess for and debunk misinformation to increase vaccine enthusiasm among medically vulnerable populations.

98 Background: Patients with cancer are at risk for severe COVID-19 and may be vulnerable to health care delays. Delays or interruptions in care may lead to adverse cancer outcomes. Little is known about the relationship between fear of COVID-19 and disruptions in cancer care delivery. Methods: This longitudinal survey was distributed to individuals with cancer who received services July 2019-April 2020 from Patient Advocate Foundation, a non-profit organization that provides case management and financial aid to patients with chronic illness. Data was collected twice - early pandemic (5/20/20-7/11/20) and later pandemic (12/3/20-12/23/20). Fear of COVID-19 was assessed with the Fear of COVID-19 Scale and dichotomized as more (≥22) vs less (< 22) fearful. Respondents reported delays in care or treatment interruptions due to the pandemic and reasons for delays or interruptions. Respondents rated concern about potential long-term health issues due to delays on a 5-point Likert-like scale. We estimated predicted percentages and 95% confidence intervals (CI) using logistic regression models to assess the association of fear of COVID-19 (more vs less fearful) with delay in care or treatment interruption (any vs none) at each time point. We adjusted models for age, sex, race/ethnicity, region, annual household income, marital status, employment status, household size, Area Deprivation Index category, Rural-Urban Commuting Code category, county-level COVID-cases per 100,000, cancer type and number of comorbidities. Results: Amongst the 1,199 early pandemic survey respondents, the majority were female (72%), had household income < $48,000 (73%), and had ≥1 comorbidity (60%). 448 of the early pandemic survey respondents also completed the later survey. 464 (39%) and 166 (37%) respondents were categorized as more fearful at the early and later time points respectively. 567 (47%) and 191 (43%) reported delays or interruptions at the early and later time points respectively. The most common reported reasons for delays or interruptions were hospital/provider restrictions (early: 27%, later: 19%) and patient choice (early: 13%, later: 15%). Among respondents with delays or interruptions at each time point, > 70% were at least moderately concerned about potential long-term health issues due to delays. In adjusted models, more fearful respondents had higher predicted percentages of delayed care or treatment interruptions compared to less fearful respondents early (more fearful: 56%, 95% CI 39%-72%; less fearful: 44%; 95% CI 28%-61%) and later (more fearful: 55%, 95% CI 35%-73%; less fearful: 38%; 95% CI 22%-57%) in the pandemic. Conclusions: Fear of COVID-19 is common among patients with cancer and is linked with delays in care and treatment interruptions. System-wide strategies are needed to address fear of COVID-19 and to ensure equitable, timely, and safe access to cancer care throughout the pandemic.

Little is known about out‐of‐pocket (OOP) costs incurred for medical and health needs by rural breast cancer survivors and what factors may be associated with higher OOP costs and the associated economic burden. Data were examined for 432 survivors participating in the Rural Breast Cancer Survivor Intervention trial. OOP costs were collected using the Work and Finances Inventory survey at baseline and four assessments every 3 months. Mean and median OOP costs and burden (percent of monthly income spent on OOP costs) were reported and factors associated with OOP costs and burden identified with generalized linear models fitted with over‐dispersed gamma distributions and logarithmic links (OOP costs) and with beta distributions with logit link (OOP burden). OOP costs per month since the end of treatment were on average $232.7 (median $95.6), declined at the next assessment point to $186.5 (median $89.1), and thereafter remained at that level. Mean OOP burden was 9% at baseline and between 7% and 8% at the next assessments. Factors suggestive of contributing to higher OOP costs and OOP burden were the following: younger age, lower income, time in survivorship from diagnosis, and use of supportive services. OOP costs burden rural breast cancer survivors, particularly those who are younger and low income. Research should investigate the impact of OOP costs and interventions to reduce economic burden.

Purpose The purpose of this paper was to examine the psychometric properties of Champion's Health Belief Model Scales for cervical cancer and screening among women living with HIV. Methods A secondary data analysis was conducted using data from an exploratory cross-sectional study with a convenience sample of 300 women living with HIV receiving care at two HIV ambulatory care clinics in Florida. A 39-item adaptation of the Champion's Health Belief Model Scales was administered via paper and pencil. Results The authors used internal consistency measures, confirmatory factor analysis, and ordinal item response theory (IRT) techniques to examine the psychometric properties of the instrument. The 39-item instrument had adequate internal consistency and factor structure. However, the IRT analyses suggested that the instrument could be reduced to 24-items (61.5%), without loss of relevant information. Conclusion A shortened 24-item instrument demonstrated good internal consistency among women living with HIV. Future work should include validating the properties of the reduced instrument in diverse samples of patients and conditions.

Background: Treatment for metastatic breast cancer (MBC) that is not concordant with the NCCN Guidelines for Breast Cancer has been associated with higher healthcare utilization and payer costs. However, a significant knowledge gap exists regarding the impact of guideline-discordant care on patient cost responsibility. This study examined this question among patients with MBC in the year postdiagnosis. Methods: This retrospective cohort study used data from the SEER-Medicare linked database from 2000 through 2013. Guideline discordance, defined by year-specific NCCN Guidelines, was assessed for first-line antineoplastic treatment and grouped into discrete categories. Patient cost responsibility (deductibles, coinsurance, copayments) in women with MBC were summed for all medical care received in the year postdiagnosis. The difference in patient cost responsibility by guideline discordance status was estimated using linear mixed-effect models. Results: Of 3,709 patients with MBC surviving at least 1 year postdiagnosis, 17.6% (n=651) received guideline-discordant treatment. Median cost responsibility in the year postdiagnosis for patients receiving guideline-discordant treatment was $7,421 (interquartile range [IQR], $4,359–$12,983) versus $5,171 (IQR, $3,006–$8,483) for those receiving guideline-concordant care. In adjusted models, guideline-discordant treatment was significantly associated with $1,841 higher patient costs in the first year from index diagnosis date (95% CI, $1,280–$2,401) compared with guideline-concordant care. Patient cost responsibility differed by category of guideline discordance, with those receiving nonapproved bevacizumab having the highest cost responsibility (β=$3,330; 95% CI, $1,711–$4,948). Conclusions: Deviations from current treatment guidelines may have implications on patient healthcare cost responsibility. Additional research is needed to fully understand the mechanisms underlying how guideline deviation leads to greater costs for patients with MBC.

6584 Background: Early stage breast cancer (EBC) treatment is used in women of all ages, races, and health states. However, as clinical trials often do not represent real-world populations, the extent to which evidence-based treatments are prescribed to populations not well represented in these trials is not known. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. Methods: This retrospective cohort study used the nationwide de-identified electronic health record derived Flatiron Health database for patients diagnosed with EBC between 2011-2020. We categorized treatments as either high- (AC-TH [doxorubicin, cyclophosphamide followed by paclitaxel or docetaxel, trastuzumab]; ACT [paclitaxel or docetaxel, doxorubicin, cyclophosphamide]; TCH [paclitaxel or docetaxel, carboplatin, trastuzumab]; TCHP [paclitaxel or docetaxel, carboplatin, trastuzumab, pertuzumab]) or low-intensity (AC [doxorubicin, cyclophosphamide]; TC [paclitaxel or docetaxel, cyclophosphamide]; TH [paclitaxel or docetaxel, trastuzumab]). Unrepresented patients often have one or more comorbidities and/or prior cancer; underrepresented patients are typically Black, Indigenous, people of color, or of age extremes ( < 45, 70+); well represented patients are White and between the ages of 45-69. Odds ratios (OR), predicted proportions, and 95% confidence intervals (CI) from a two-level (patients nested in practice) hierarchical logistic regression model evaluated associations between receipt of high-intensity chemotherapy and patient characteristics of clinical trial representation (age, race/ethnicity, presence of comorbidity). Results: Our study included 970 patients with EBC with 13%, 45%, and 41% characterized as unrepresented, underrepresented, and well represented in clinical trials, respectively. In the adjusted model, those aged ≥ 70 vs 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 vs 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). The predicted proportion of patients receiving a high-intensity treatment was 87% (95% CI: 80%-92%) for patients aged < 45, 79% (95% CI: 74%-84%) for patients aged 45-69, and 60% (95% CI: 50%-70%) for patients aged ≥ 70. Neither race/ethnicity nor comorbidity status were associated with odds of receiving high-intensity chemotherapy. Conclusions: Over half of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity, despite a lack of evidence that these differences are appropriate. Widening clinical trial eligibility criteria is one way to better understand survival outcomes, identify potential toxicities, and ultimately make evidence-based treatment decisions using a more diverse sample.

Purpose Hypertension is a risk factor for cardiovascular disease (CVD) in adults and children and has its origins in childhood. While the prevalence of hypertension in children is estimated to be 2 to 5%, instance elevations in blood pressure readings (BPRs) in school-age children and adolescents are more common, track to adulthood, and are an independent risk factor for CVD. Less information is available about BPR in the preschool period and what child factors could influence those BPR. The primary aims of this exploratory study were to determine child blood pressure (BP) levels and determine effect sizes of the relationships between child and maternal factors that can influence child BP. Methods A convenience sample of 15 rural and 15 urban children enrolled in Head Start programs (13 males; 14 females; all black) with ability to understand and speak English and with mothers who gave consent and could understand, read and speak English were enrolled. Mothers completed demographic information about their child including, gender, birth history and age. Height, weight, waist circumference and BP were measured in the mothers and the children. Children gave saliva specimens for cortisol and C-reactive protein. Results Over 37% of the children had elevated BPR with over 20% at or above the 95th percentile. Effect sizes of relationships ranged from very small to large. Conclusion Elevations in BPR may be seen as early as preschool. It is important to examine factors, both child and maternal that influence BP.

Background and Purpose: The Resistiveness to Care Scale for Dementia of the Alzheimer's Type was developed to quantify care-resistant behavior. The purpose of this article is to explain how the instrument was modified and tested in two clinical studies that examined interventions to improve the oral hygiene of persons with dementia who resist care. Methods: After pilot testing, the revised instrument (RTC-r) was used in 7 facilities (N = 83 residents). Systematic training procedures were implemented to preserve reliability. Results: Clinical validity was confirmed throughout the pilot and interventional studies. Reliability was assessed using inter-rater reliability, which ranged from 0.87 (p < .001) to 1.0 (p < .001) across 2,328 mouth care observations. Conclusions: The RTC-r validly and reliably measures care-resistant behavior in persons with dementia.

125 Background: Clinical trials are used to generate standard-of-care, yet often do not reflect patient populations treated in real-world settings. Elderly patients or patients of color who are often underrepresented in trials, which may impact what types of treatments are prescribed. This study examines how patient characteristics are associated with treatment intensity in early stage breast cancer. Methods: This retrospective cross-sectional study included women with a stage I-III breast cancer from American Society of Clinical Oncology’s CancerLinQ database treated by chemotherapy from 2005-2019. Seven standard-of-care regimens were characterized by intensity. For patients with ER+/- HER2- breast cancer, low-intensity regimens were Taxol and Cyclophosphamide or Adriamycin and Cyclophosphamide; while Taxol, Adriamycin, and Cyclophosphamide was considered high intensity. For patients with HER2+ breast cancer, the low intensity regimen was Taxol and Herceptin; while Adriamycin and Cyclophosphamide followed by Taxol and Herceptin; Taxol, Carboplatin, and Herceptin; or Taxol, Carboplatin, Herceptin, and Pertuzumab were considered high intensity. A model estimating the likelihood of intensity was calculated using log-binomial regression, in order to produce relative risks. The models were adjusted for patient demographics and cancer stage. Results: Of 24,383 patients, 51% had ER+HER2-, 20% ER-HER2-, and 29% HER2+ breast cancer. Most patients were White (60%), age 40-69 (80%), had stage II breast cancer (39%), and received higher intensity treatment (65%). Adjusted for the other covariates, patient who were Black were more likely to receive high-intensity treatment than patients who were White (61% vs 58%; RR 1.05, 95%CI 1.02-1.06. Additionally, older adults were more likely to receive low-intensity treatment, with 42% of patients over 70 receiving low intensity treatment, and 29% of patients between the ages 40 and 69 received low intensity treatment (RR 1.5, 95% CI 1.44 -1.54). Conclusions: Differences in treatment intensity were observed for patients with differing demographic characteristics. Further research is needed to determine lack of representation in clinical trials impacts on prescribing patterns, regimen intensity, and survival.

OBJECTIVES: The Healthy Eating Index (HEI)-2015 is a measure of diet quality in reference to the 2015 Dietary Guidelines for Americans. We examined the relationship between HEI-2015 and several indices of cardiometabolic risk factors among individuals with chronic spinal cord injury (SCI) (>3 years after injury). METHODS: Twenty-four participants without type 2 diabetes were included (45 ± 12 y, 8F/16 M, 9 Tetraplegia/15 Paraplegia, time since injury: 20 ± 13 y). All participants underwent a 2-hour oral glucose tolerance test (OGTT), a Dual-energy X-ray absorptiometry scan (DXA), and 3 24-hour multiple-pass dietary recalls. HEI-2015 was calculated using the dietary recall data. To build the regression model, firstly, principal component (PC) analysis was used to reduce the number of covariates from 3 (level of injury, gender, percentage body fat estimated from the DXA) to 2 PCs. Multiple linear regression analyses were run to predict indices of lipid metabolism and glucose homeostasis as well as C-reactive protein (CRP) from the HEI and the 2 PC scores. RESULTS: The average HEI-2015 score was lower for participants with SCI compared to the general American population (48 ± 11 vs. 59, P 13%), indicating good explanatory ability of the predictors. Small or limited effect sizes were observed for other models (glucose tolerance, fasting insulin, triaglycerides, and Matsuda index, adjusted R(2)

OBJECTIVES/GOALS: This work-in-progress aims to: 1) identify and differentiate symptom pattern trajectories in a sample of older adult heart failure (HF) patients over 24 weeks, and 2) examine associations between sociodemographic/clinical/physiological characteristics, dyadic health, and symptom trajectories. METHODS/STUDY POPULATION: ENABLE CHF-PC, a palliative care RCT (NCT02505425), was conducted at a Southeastern US medical center. Between 2016-2018, 415 older adult HF patients and 159 family caregivers were randomized to receive a psychoeducational intervention or usual care. Baseline sociodemographic information (age, gender, rurality, etc.) were collected. Outcome variables of interest include symptoms (Kansas City Cardiomyopathy Questionnaire (KCCQ), Functional Assessment of Chronic Illness Therapy-Palliative 14, Hospital Anxiety and Depression Scale (HADS)) and dyadic health (PROMIS-SF Global Health). We have calculated baseline descriptive statistics. Future work includes latent growth mixture modeling to identify distinct symptom trajectories and univariate associations with patient level factors. RESULTS/ANTICIPATED RESULTS: Of 415 patient participants, mean age was 64, 53% were male; 55% were African American; 26% were rural dwellers; 46% had +15.8) and low anxiety (6.7+3.6) and depressive symptoms (5.7+4.3) on the HADS. Of 159 family caregivers participants, the mean age was 57.9, 85.4% were female, 51.9% were African-American, and 65.2% were the patient’s spouse/partner. DISCUSSION/SIGNIFICANCE OF IMPACT: Limited data describes HF symptom pattern trajectories.How co-occurring symptoms affect quality of life or are affected by personal or situational factors are not well-understood. This study will help to identify factors and symptom phenotypes that may serve as targets for future interventions.

Importance Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. Objective To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks. Design, Setting, and Participants This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018. Intervention Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention. Main Outcomes and Measures The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving. Results A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient’s spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, −0.4; 95% CI, −5.1 to 4.3; Cohend = −0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, −0.1 [0.5];d = −0.02) or depression measure (mean [SE] improvement from baseline, −0.2 [0.4] vs −0.3 [0.3]; difference, 0.1 [0.5];d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (drange, −0.18 to 0.0). Differences in secondary outcomes were also not significant (drange, −0.22 to 0.0). Conclusions and Relevance This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

Background Understanding factors that impact patient satisfaction with cancer care within the growing population of older adults living with cancer will contribute to tailoring programs that address patient needs and expectations. Further, patient satisfaction is a determinant of healthcare organizations' institutional performance. The purpose of this study was to investigate the relationship between patient satisfaction with care and health-related quality of life (HRQoL) among Medicare recipients with common cancers types (breast, prostate, or lung cancer). Methods Cross-sectional analysis of survey data from 637 Medicare beneficiaries (≥65 years) with breast (n = 304), lung (n = 158), or prostate cancer (n = 175) in twelve hospitals in the Southeastern United States. Participants responded eighteen satisfaction questions across five domains. HRQoL was measured with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the SF-12.v2 instrument. Results SF-12 scores were positively associated with satisfaction domain scores. The magnitude of these associations was small with covariate-adjusted effect sizes r ranging from 0.05 to 0.12. Satisfaction scores were highest within the Quality of Care domain and lowest within the Patient Engagement domain. Conclusions Patient satisfaction domains had only modest association with HRQoL, indicating that these constructs should not be assumed to correlate. Satisfaction domains, including how patients access care, coordinate care, and engage within the healthcare system, were identified as potential areas for improvement. Patient satisfaction assessment across age groups may inform oncology care providers on ways in which their patients perceive the quality of care received, which ultimately affect healthcare organizations' accreditation, ranking, and reimbursement.

This study presents feasibility and acceptability data on the use of a real-time wireless electronic adherence monitor (EAM), among African American women living with HIV with co-occurring depression, residing in remote areas of the Southeastern United States. EAM and self-report ART adherence was monitored over an average of 14.8 weeks among 25 participants who were recruited at four HIV clinics in Alabama. Intra-class correlation showed a low degree of concordance between EAM and self-report (ICC = 0.33, 95% bootstrap CI: 0.13, 0.59). 83% of data collected via EAM was transmitted in real-time. Due to technological failures, 11.4% were not transmitted in real-time, but were later recovered, and 5.7% were lost entirely. Acceptability was examined through surveys and qualitative interviews. Results suggest that EAM monitoring is acceptable and feasible in a rural US setting; however, technological difficulties, such as loss of connectivity may impede the device’s usefulness for just-in-time adherence interventions.

OBJECTIVES To explore and estimate relationships among the elements of the symptom cluster in survivors of brain tumors aged 8-12 years during early survivorship. SAMPLE A SETTING Child participants completed treatment at least six months and less than six years prior to enrollment at Children's Hospital of Alabama in Birmingham or Cook Children's Medical Center in Fort Worth, Texas. METHODS A VARIABLES With cross-sectional methods, the authors measured child-perceived stress, sleep-wake disturbance (SWD) (parent report), and fatigue. Children also provided saliva samples for cortisol measurement (stress response) and completed actigraphy sleep monitoring. RESULTS Mild to moderate stress, SWD, and fatigue were reported, and a wide range of sleep times and cortisol levels were noted. Meaningful effect sizes in relationships between variables were found. IMPLICATIONS FOR NURSING The stress, SWD, and fatigue symptom cluster in survivorship necessitates routine nursing assessment.

Commentary on: Blackman I, Lye CY, Darmawan IGN, et al . Modeling missed care: implications for evidence-based practice. Worldviews Evid Based Nurs . 2018. doi: 10.1111/wvn.12285 In the past two decades, a compelling body of evidence1 2 has linked higher nurse-to-patient ratios, higher proportion of baccalaureate-prepared nurses and higher total nursing care hours to lower patient mortality, decreased length of stay and a lower likelihood of patient complications such as nosocomial infections and pressure injuries. Many of these studies used a complex mix of data sources including medical and administrative hospital records from which patient outcomes, …

Background: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) have directed the care of patients with cancer for >20 years. Payers are implementing guideline-based pathway programs that restrict reimbursement for non-guideline-based care to control costs, yet evidence regarding impact of guidelines on outcomes, including mortality, Medicare costs, and healthcare utilization, is limited. Patients and Methods: This analysis evaluated concordance of first treatment with NCCN Guidelines for women with de novo stage IV metastatic breast cancer (MBC) included within the SEER-Medicare linked database and diagnosed between 2007 and 2013. Cox proportional hazards models were used to evaluate the association between mortality and guideline concordance. Linear mixed-effects and generalized linear models were used to evaluate total cost to Medicare and rates of healthcare utilization by concordance status. Results: We found that 19% of patients (188/988) with de novo MBC received nonconcordant treatment. Patients receiving nonconcordant treatment were more likely to be younger and have hormone receptor-negative and HER2-positive MBC. The most common category of nonconcordant treatment was use of adjuvant regimens in the metastatic setting (40%). Adjusted mortality risk was similar for patients receiving concordant and nonconcordant treatments (hazard ratio [HR], 0.85; 95% confidence limit [CL], 0.69, 1.05). When considering category of nonconcordance, patients receiving adjuvant regimens in the metastatic setting had a decreased risk of mortality (HR, 0.60; 95% CL, 0.43, 0.84). Nonconcordant treatments were associated with $1,867 higher average Medicare costs per month compared with concordant treatments (95% CL, $918, $2,817). Single-agent HER2-targeted therapy was the highest costing category of nonconcordance at $3,008 (95% CL, $1,014, $5,001). Healthcare utilization rates were similar for patients receiving concordant and nonconcordant treatments. Conclusions: Despite a lack of survival benefit, concordant care was associated with lower costs, suggesting potential benefit to increasing standardization of care. These findings may influence policy decisions regarding implementation of pathway programs as health systems transition to value-based models.