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Abstract Background Though financial hardship is a well‐documented adverse effect of standard‐of‐care cancer treatment, little is known about out‐of‐pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation. Methods This cross‐sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness. Surveys included questions on cancer clinical trial participation, trial‐related financial hardship, and sociodemographic data. Descriptive and bivariate analyses were conducted using Cramer's V to estimate the in‐sample magnitude of association. Associations between trial‐related financial hardship and sociodemographics were estimated using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. Results Of 650 survey respondents, 18% (N = 118) reported ever participating in a cancer clinical trial. Of those, 47% (n = 55) reported financial hardship as a result of their trial participation. Respondents reporting trial‐related financial hardship were more often unemployed or disabled (58% vs. 43%; V = 0.15), Medicare enrolled (53% vs. 40%; V = 0.15), and traveled >1 h to their cancer provider (45% vs. 17%; V = 0.33) compared to respondents reporting no hardship. Respondents who experienced trial‐related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 h vs. ≤30 min to their cancer provider had a 2.2× higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR = 2.2, 95% CI 1.3–3.8). Most respondents (53%) reported needing $200–$1000 per month to compensate for trial‐related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a cancer clinical trial (n = 532), 13% declined participation due to cost. Conclusion Cancer clinical trial‐related financial hardship, most often stemming from travel expenses, affected almost half of trial‐enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation.

Abstract Background We aimed to describe the roles and challenges of family caregivers involved in patients' cancer treatment decision‐making. Methods Family caregiver‐reported data were analyzed from a national survey conducted in the United States by CancerCare® (2/2021–7/2021). Four select‐all‐that‐apply caregiver roles were explored: (1) observer (patient as primary decision‐maker); (2) primary decision‐maker; (3) shared decision‐maker with patient and (4) decision delegated to healthcare team. Roles were compared across five treatment decisions: where to get treatment, the treatment plan, second opinions, beginning treatment and stopping treatment. Ten challenges faced by caregivers (e.g., information, cost, treatment understanding) were then examined. χ2 and regression analyses were used to assess associations between roles, decision areas, challenges and caregiver sociodemographics. Results Of 2703 caregiver respondents, 87.6% reported involvement in patient decisions about cancer treatment, including 1661 who responded to a subsection further detailing their roles and challenges with specific treatment decisions. Amongst these 1661 caregivers, 22.2% reported an observing role, 21.3% a primary decision‐making role, 53.9% a shared decision‐making role and 18.1% a role delegating decisions to the healthcare team. Most caregivers (60.4%) faced ≥1 challenge, the most frequent being not knowing how treatments would affect the patient's physical condition (24.8%) and quality of life (23.2%). In multivariable models, being Hispanic/Latino/a was the strongest predictor of facing at least one challenge (b = −0.581, Wald = 10.69, p

Abstract Background Family caregivers play an increasing role in cancer treatment decision‐making. We examined bias reported by family caregivers in the support they and their patient received from their healthcare team when making these decisions, including associations with distress. Methods Analysis of 2021 national survey data of family caregivers of patients with cancer (N = 2703). Bias experienced in decision support was assessed with the item: “Have you felt that the support you and the person with cancer have received for making cancer‐related decisions by your doctor or healthcare team has been negatively affected by any of the following?” Check‐all‐that‐apply response options included: age, race, language, education, political affiliation, body weight, insurance type or lack of insurance, income, religion, sexual orientation, and gender/sex. Chi‐square and regression analyses assessed associations between bias and caregiver distress (GAD‐2, PHQ‐2). Results Of 2703 caregiver respondents, 47.4% (n = 1281) reported experiencing ≥1 bias(es) when receiving decision support for making cancer‐related decisions. Bias was more prevalent among younger caregivers, males, transwomen/men or gender non‐conforming caregivers, racial/ethnic minorities, and those providing care over a longer time period. The odds of having high anxiety (GAD‐2 scores ≥ 3) were 2.1 times higher for caregivers experiencing one type of bias (adjusted OR, 2.1; 95% CI, 1.6–2.8) and 4.2 times higher for caregivers experiencing ≥2 biases (adjusted OR, 4.2; 95% CI, 3.4–5.3) compared to none. Similar results were found for high depression scores (PHQ‐2 scores ≥ 3). Conclusions Nearly half of caregivers involved in their care recipients' cancer‐related decisions report bias in decision support received from the healthcare team. Experiencing bias was strongly associated with high psychological distress.

Drug overdose is the leading cause of accidental death in the United States, with over 70% of drug related fatalities resulting from the use of opioids. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as training laypersons to administer naloxone through Opioid Overdose Education and Naloxone Distribution (OEND) programs. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are both safe and cost-effective, however, they are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current study examined the acceptability and feasibility of online recruitment, online opioid overdose education, and remote distribution of naloxone kits. Persons who illicitly use opioids and are at risk for overdose were recruited through online media and completed an opioid use questionnaire. If interested in receiving opioid overdose and naloxone administration training, participants completed pre- and post-intervention knowledge questionnaires, engaged in audiovisual training, and were randomized to either receive a naloxone kit or be given information on where they could obtain one. Preliminary results indicate feasibility and acceptability as evidenced by strong recruitment and retention, as well as high participant satisfaction ratings. Successful implementation of remote OEND through this project supports future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs. Trial Registration #: Clinitaltrials.gov- NCT04303000.

Abstract Background Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer. Methods This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin’s Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20–60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient’s death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient’s death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated. Discussion Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances. Trial registration ClinicalTrials.gov NCT04318886 . Registered on 20 March, 2020.

Abstract Background Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. Methods This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. Discussion This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. Trial registration NCT04809740 ; date of registration 3/22/2021.

Prediabetes affects 38% of U.S. adults and is primarily linked to added sugars consumed from sugar-sweetened beverages. It is unclear if total dietary intake of added sugar also increases the risk for prediabetes. This study examined if total (g/day) and percent intakes of 15% added sugar increase the odds for prediabetes in U.S. adults. A cross-sectional, secondary analysis using 2013-2018 NHANES data was conducted. This study included data from U.S. adults ≥ 20 years with normoglycemia (N = 2,154) and prediabetes (N = 3,152) with 1-2 days of dietary recall information. Prediabetes was defined as a hemoglobin A1c of 5.7%-6.4% or a fasting plasma glucose of 100-125 mg/dL. Survey-weighted logistic regression was used to estimate odds ratios of prediabetes based on usual intakes of added sugar (total and percent intakes) using the National Cancer Institute Method. Differences in prediabetes risk and total and percent intakes of added sugar were compared by race/ethnicity. The sample's total energy intake from added sugar was 13.9%. Total (unadjusted: OR: 1.01, 95% CI: .99-1.00, p = .26; adjusted: OR: 1.00, 95% CI: .99-1.00, p = .91) and percent intakes of added sugar (unadjusted [15%: OR: 1.03, 95% CI: .82-1.28, p = .82] and adjusted [15%: OR: .96, 95% CI: .74-1.24, p = .73]) were not significantly associated with an increased odds of prediabetes. Prediabetes risk did not differ by race/ethnicity for total (unadjusted model [p = .65]; adjusted model [p = .51]) or percent (unadjusted model [p = .21]; adjusted model [p = .11]) added sugar intakes. In adults ≥20 years with normoglycemia and prediabetes, total added sugar consumption did not significantly increase one's risk for prediabetes and risk estimates did not differ by race/ethnicity. Experimental studies should expand upon this work to confirm these findings.

Abstract 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.

Background Acute kidney injury (AKI) is a common cause of morbidity and mortality. It mainly targets the renal tubular epithelium with pathological changes, referred to as acute tubular injury. The latter is followed by a regenerative response that is difficult to visualize on routine hematoxylin and eosin (H&E) stains. In this study, we examined the regenerative capacity of renal tubules by correlating vimentin (VIM) immunohistochemical (IHC) expression and pathological findings of AKI and renal tubular regeneration (RTR) on H&E. Methods We reviewed 23 autopsies performed in the clinical setting of AKI and RTR. VIM expression was scored in the renal cortical tubular epithelium using a statistical cutoff ≥ 3% for high expression and < 3% for low expression. Results Of the 23 kidney tissues examined, seven (30.4%) had low VIM expression, and 16 (69.6%) had high VIM expression. Kidney tissues with evidence of AKI and RTR had significantly higher VIM expression. Renal peritubular microenvironment features showing regenerative changes on H&E were associated with high VIM expression. In the univariate model, kidney tissues with RTR were 18-fold more likely to have high VIM expression. Conclusions In conclusion, our findings suggest that VIM could serve as an IHC marker for RTR following AKI. However, correlation with H&E findings remains critical to excluding chronic tubular damage. Collectively, our preliminary results pave the way for future studies including a larger sample size to validate the use of VIM as a reliable biomarker for RTR.

BackgroundWhile tobacco use among individuals involved in the criminal legal system remains 3–4 times higher than the general population, few interventions have been targeted for this population to aid in smoking cessation. Nicotine replacement therapy (NRT) is a relatively effective and accessible smoking cessation aid; however, individuals frequently stop use of NRT early due to side effects and misperceptions about the products. The present study aims to address low medication adherence by examining the efficacy of an “in vivo” NRT sampling experience in individuals under community criminal legal supervision.MethodsFollowing recruitment through community legal outlets, participants (N = 517) are randomized to either an “in vivo NRT sampling” group or a standard smoking cessation behavioral counseling group. The in vivo group uses NRT in session and discusses perceptions and experiences of using NRT in real time while the standard smoking cessation counseling group receives four sessions of standard behavioral smoking cessation counseling. Both groups receive four intervention sessions and 12 weeks of NRT following the intervention. The 6-month post-intervention primary outcome measures are smoking point-prevalence abstinence and medication adherence.ConclusionThis is a novel smoking cessation intervention specifically aimed at increasing NRT adherence and smoking cessation among those involved in the criminal legal system, a group of individuals with high smoking rates and low rates of pharmacotherapy use. If proven effective, the present treatment could be a novel intervention to implement in criminal legal settings given the minimal requirement of resources and training.This trial is registered with www.clinicaltrials.gov-NCT02938403

Abstract Background Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration Clinicaltrials.gov . NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

Abstract 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.

Abstract 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.

Background: Patients newly-diagnosed with advanced cancer often rely on family caregivers to provide daily support to manage healthcare needs and maintain quality of life. Early telehealth palliative care has been shown to effectively provide an extra layer of support to family caregivers, however there has been little work with underserved populations, especially African-Americans and rural-dwellers. This is concerning given the lack of palliative care access for these underserved groups. Study design: Single-site, small-scale pilot randomized controlled trial (RCT) of Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African-American and rural-dwelling patients with newly-diagnosed advanced cancer. Family caregivers are paired with a trained lay navigator overseen by specialist palliative care clinicians and receive a series of brief in-person and telehealth sessions focusing on stress management and coping, caregiving skills and organization, getting help, self-care, and preparing for the future/advance care planning. This pilot trial is assessing acceptability of the intervention, feasibility of recruitment and data collection procedures, and preliminary efficacy compared to usual care on caregiver and patient quality of life and mood over 24 weeks. Conclusion: Once acceptability and feasibility are determined and issues addressed, the ENABLE Cornerstone intervention for underserved family caregivers of persons with advanced cancer will be primed for a fully powered efficacy RCT. Given its use of lay navigators and telehealth delivery, the intervention is potentially highly scalable and capable of overcoming many of the geographic, human resource, and cultural obstacles to accessing early palliative care support. Keywords: Family caregivers, Advanced cancer, Telehealth, Palliative care, Rural

Abstract 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.

Abstract Background Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). Methods We conducted an EPC feasibility study (4/1/14–8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. Results We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients’ hospital and ICU days and emergency visits. Conclusions Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Trial registration Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

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.

OBJECTIVE: to test a theoretical model based on the Parent-Based Expansion of the Theory of Planned Behavior examining relation between selected parental, teenager and cultural variables and Latino teenagers' intentions to engage in sexual behavior.METHOD: a cross-sectional correlational design based on a secondary data analysis of 130 Latino parent and teenager dyads.RESULTS: regression and path analysis procedures were used to test seven hypotheses and the results demonstrated partial support for the model. Parent familism and knowledge about sex were significantly associated with parents' attitudes toward sexual communication with their teenagers. Parent Latino acculturation was negatively associated with parents' self-efficacy toward sexual communication with their teenagers and positevely associated with parents' subjective norms toward sexual communication with their teenagers. Teenager knowledge about sex was significantly associated with higher levels of teenagers' attitudes and subjective norms about sexual communication with parents. Only the predictor of teenagers' attitudes toward having sex in the next 3 months was significantly associated with teenagers' intentions to have sex in the next 3 months.CONCLUSION: the results of this study provide important information to guide future research that can inform development of interventions to prevent risky teenager sexual behavior among Latinos.

OBJECTIVES/SPECIFIC AIMS: Our primary objective was to understand the relationship between incident or recent stressful events and adherence to HIV care in the context of other person, environment, and HIV-specific stressors in a sample of Black women living with HIV (WLWH). METHODS/STUDY POPULATION: Thirty in-depth interviews were conducted with Black women living with HIV who receive care at an academic HIV primary care clinic in the Southern region of the United States to elicit stressful events influencing adherence to HIV care. Semi-structured interview guides were used to facilitate discussion regarding stressful events and adherence to HIV care. Interviews were audiotaped and transcribed verbatim. Transcripts were independently coded using a theme-based approach by two experienced coders, findings were compared, and discrepancies were resolved by discussion. RESULTS/ANTICIPATED RESULTS: Participants described frequently experiencing incident stressful events including death or serious illness of a close friend or family member, and relationship, financial, and employment difficulties. Furthermore, participants reported experiencing traumatic events such as sexual and physical abuse during childhood and adolescents. While experiencing traumatic events such as sexual and physical abuse during childhood and adolescence may be distressing, these events did not influence adherence to HIV care. However, incident stressful events as defined above did influence adherence to HIV care for some participants, but not for others. For participants who reported that stressful events did not influence adherence to HIV care, factors such as personal motivation, access to social support, and adaptive coping strategies facilitated their engagement in care. DISCUSSION/SIGNIFICANCE OF IMPACT: Experiencing stressful events, incident or traumatic, is common among Black WLWH and have the potential to negatively influence adherence to HIV care. Thus, Interventions aimed at identifying and addressing stress, social support, and coping are essential to improve adherence to HIV care behaviors.

Purpose: This study aimed to test the construct validity of an instrument to measure student professional behaviors in entry-level occupational therapy (OT) students in the academic setting. Methods: A total of 718 students from 37 OT programs across the United States answered a self-assessment survey of professional behavior that we developed. The survey consisted of ranking 28 attributes, each on a 5-point Likert scale. A split-sample approach was used for exploratory and then confirmatory factor analysis. Results: A three-factor solution with nine items was extracted using exploratory factor analysis [EFA] (n=430, 60%). The factors were ‘Commitment to Learning’ (2 items), ‘Skills for Learning’ (4 items), and ‘Cultural Competence’ (3 items). Confirmatory factor analysis (CFA) on the validation split (n=288, 40%) indicated fair fit for this three-factor model (fit indices: CFI=0.96, RMSEA=0.06, and SRMR=0.05). Internal consistency reliability estimates of each factor and the instrument ranged from 0.63 to 0.79. Conclusion: Results of the CFA in a separate validation dataset provided robust measures of goodness-of-fit for the three-factor solution developed in the EFA, and indicated that the three-factor model fitted the data well enough. Therefore, we can conclude that this student professional behavior evaluation instrument is a structurally validated tool to measure professional behaviors reported by entry-level OT students. The internal consistency reliability of each individual factor and the whole instrument was considered to be adequate to good.

BackgroundStudies in populations unexposed to folic acid (FA) fortification have demonstrated that MTHFR C677T polymorphism is associated with increased risk of higher grades of cervical intraepithelial neoplasia (CIN 2+). However, it is unknown whether exposure to higher folate as a result of the FA fortification program has altered the association between MTHFR C677T and risk of CIN, or the mechanisms involved with such alterations. The current study investigated the following in a FA fortified population: 1) The association between MTHFR C677T polymorphism and risk of CIN 2+; 2) The modifying effects of plasma folate concentrations on this association; and 3) The modifying effects of plasma folate on the association between the polymorphism and degree of methylation of long interspersed nucleotide elements (L1s), in peripheral blood mononuclear cell (PBMC) DNA, a documented biomarker of CIN risk.MethodsThe study included 457 US women diagnosed with either CIN 2+ (cases) or ≤ CIN 1 (non-cases). Unconditional logistic regression models were used to test the associations after adjusting for relevant risk factors for CIN.ResultsThe 677CT/TT MTHFR genotypes were not associated with the risk of CIN 2+. Women with CT/TT genotype with lower folate, however, were more likely to be diagnosed with CIN 2+ compared to women with CT/TT genotype with higher folate (OR = 2.41, P = 0.030). Women with CT/TT genotype with lower folate were less likely to have a higher degree of PBMC L1 methylation compared to women with CT/TT genotype with higher folate (OR = 0.28, P = 0.017).ConclusionsThis study provides the first evidence that the MTHFR 677CT/TT genotype-associated lower degree of PBMC L1 methylation increases the risk of CIN 2+ in women in the US post-FA fortification era. Thus, even in the post-FA fortification era, not all women have adequate folate status to overcome MTHFR 677CT/TT genotype-associated lower degree of L1 methylation.