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Background: The purpose of the Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) Program, a Cancer Moonshot℠ Initiative, is to support research to build the evidence base on multilevel interventions that increase rates of colorectal cancer screening, follow-up, and referral to care to address disparities in colorectal cancer screening. The National Cancer Institute funded eight Research Projects to implement multilevel interventions to improve colorectal cancer screening among communities who traditionally have been medically underserved. To analyze the impact of ACCSIS across Research Projects, the consortium developed a set of common data elements. The purpose of this paper is to describe the process of developing the common data elements to facilitate analysis of ACCSIS data as well as support and inform implementation science research studies. Methods: The ACCSIS Data, Design, and Analysis Work Group was tasked with designing common data elements through a review of existing data collection instruments, examination of data elements proposed by the ACCSIS Research Projects, and deliberations on the data required to compare across the Research Projects. ACCSIS Consortium members drafted, revised, and finalized a common data elements document consisting of variables to collect and surveys to administer to evaluate ACCSIS implementation activities and outcomes in a standardized manner across the Research Projects. Results: The ACCSIS Consortium decided to collect the following categories of common data elements: characteristics across multiple levels of the multicomponent interventions, implementation climate, and determinants; interventions and strategies; implementation outcome constructs and definitions; colorectal cancer screening episodes (screening, diagnostic testing follow-up, cancer detection, and cancer treatment); and cost measures. To assess implementation climate, the consortium prioritized constructs from five domains of the Consolidated Framework for Implementation Research. Conclusions: The ACCSIS common data elements offer a set of harmonization data for future implementation efforts. The consortium is conducting a systematic assessment using both quantitative and qualitative approaches to assess data quality and approaches to improve and sustain data collection. Lessons learned from these ongoing activities will offer additional insights to tailor the ACCSIS common data elements and support efforts to increase colorectal cancer screening for populations experiencing disparities. [ABSTRACT FROM AUTHOR]

Several recent studies have investigated the validity of precautionary practices for lymphedema risk reduction after breast cancer treatment, such as avoidance of blood pressure measurements, skin puncture, blood draws, and use of prophylactic compression during air travel. Other studies have elucidated risk factors for breast cancer-related lymphedema, such as axillary lymph node dissection and skin infection (cellulitis). Combining the current evidence base with the consensus opinion of lymphatic experts assembled at the American Cancer Society/Lymphology Association of North America Summit in October 2023, updated evidence-based risk reduction recommendations are presented for those with or at risk of breast cancer-related lymphedema. Recommendation topics include prospective surveillance, patient education, individual risk factors, exercise, blood pressure, skin care and hygiene, skin puncture and blood draws, surgical procedures, prophylactic compression, air travel, and hot climate and sauna. These recommendations will help inform education and medical choices for individuals treated for breast cancer who are at risk of or diagnosed with breast cancer-related lymphedema. More high-quality evidence is required to allow the development of risk reduction recommendations for other cancer types such as gynecological, melanoma, and head and neck. It is recommended that clinicians and organizations serving people at risk of or with lymphedema align risk reduction guidelines with the evidence-based recommendations provided within this consensus document and companion manuscripts from the American Cancer Society/Lymphology Association of North America Lymphedema Summit: Forward Momentum: Future Steps in Lymphedema Management. [ABSTRACT FROM AUTHOR]

Extensive research supports an evidence-base for cancer treatment-related risk factors, including extent of lymph node dissection and use of radiotherapy, as contributing to secondary lymphedema. Additionally, comorbidities, such as higher body mass index, and vascular-related conditions are identified to further augment risk. While social determinants of health (SDOH) and socioeconomic factors are widely regarded as influencing an individual's healthcare outcomes, including cancer risk and survival, these factors have not been explored as risk factors for developing secondary lymphedema. A rapid literature review explored the current evidence for SDOH as risk factors for lymphedema. Studies that were published over the last 10 years and that specifically analyzed social factors as variables associated with lymphedema were included. Studies that only characterized the social determinants of the study population were not included. Forty-nine studies were identified through a rapid literature review, and 13 studies that expressly analyzed social determinants as risk factors for secondary lymphedema were reviewed and extracted. All studies were conducted in patients with breast cancer-related lymphedema. Social risk factors included race, educational level, insurance type, and income level. These are consistent with the socioeconomic inequalities related to cancer survival. SDOH may influence the risk of developing cancer treatment-related health conditions like secondary lymphedema. Research trials studying cancer treatment-related conditions should collect consistent and robust data across social, behavioral, environmental, and economic domains and should analyze these variables to understand their contribution to study endpoints. Risk prediction modeling could be a future pathway to better incorporate social determinants, along with medical and co-morbidity data, to holistically understand lymphedema risk. [ABSTRACT FROM AUTHOR]

Purpose: To assess the comparative effectiveness of a tailored, interactive digital video disc (DVD) intervention versus DVD plus patient navigation (PN) intervention versus usual care (UC) on the uptake of colorectal cancer (CRC) screening among females living in Midwest rural areas. Methods: As part of a larger study, 663 females (ages 50–74) living in rural Indiana and Ohio and not up‐to‐date (UTD) with CRC screening at baseline were randomized to one of three study groups. Demographics , health status/history, and beliefs and attitudes about CRC screening were measured at baseline. CRC screening was assessed at baseline and 12 months from medical records and self‐report. Multivariable logistic regression was used to determine whether females in each group were UTD for screening and which test they completed. Results: Adjusted for covariates, females in the DVD plus PN group were 3.5× more likely to complete CRC screening than those in the UC group (odds ratio [OR] 3.62; 95% confidence interval [CI]: 2.09, 6.47) and baseline intention to receive CRC screening (OR 3.45, CI: 2.21,5.42) at baseline. Adjusting for covariates, there was no difference by study arm whether females who became UTD for CRC screening chose to complete a colonoscopy or fecal occult blood test/fecal immunochemical test. Conclusions: Many females living in the rural Midwest are not UTD for CRC screening. A tailored intervention that included an educational DVD and PN improved knowledge, addressed screening barriers, provided information about screening test options, and provided support was more effective than UC and DVD‐only to increase adherence to recommended CRC screening. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to understand how health-related quality of life (HRQoL) differs by race/ethnicity in colorectal (CRC) survivors. We aimed to 1) examine racial/ethnic disparities in HRQoL, and 2) explore the roles of social determinants of health (SDOH) risk factors for HRQoL differ by racial/ethnic groups. Methods: In 2,492 adult CRC survivors using Behavioral Risk Factor Surveillance System (BRFSS) survey data (from 2014 to 2021, excluding 2015 due to the absence of CRC data), we used the Centers for Disease Control and Prevention (CDC) HRQoL measure, categorized into "better" and "poor." Multivariate logistic regressions with prevalence risk (PR) were employed for our primary analyses. Results: Compared with non-Hispanic Whites (NHW), non-Hispanic Blacks (NHB) (PR = 0.61, p =.045) and Hispanics (PR = 0.32, p <.001) reported worse HRQoL in adjusted models. In adjusted models, unemployed/retired and low-income levels were common risk factors for worse HRQoL across all comparison groups (NHW, NHB, non-Hispanic other races, and Hispanics). Other SDOH associated with worse HRQoL include divorced/widowed/never married marital status (non-Hispanic other races and Hispanics), living in rural areas (NHW and NHB), and low education levels (NHB and Hispanics). Marital status, education, and employment status significantly interacted with race/ethnicity, with the strongest interaction between Hispanics and education (PR = 2.45, p =.045) in adjusted models. Conclusion: These findings highlight the need for culturally tailored interventions targeting modifiable factors (e.g., social and financial supports, health literacy), specifically for socially vulnerable CRC survivors, to address the disparities in HRQoL among different racial/ethnic groups. [ABSTRACT FROM AUTHOR]

Background: The technical aspects of cancer surgery have a significant impact on patient outcomes. To monitor surgical quality, in 2020, the Commission on Cancer (CoC) revised its accreditation standards for cancer surgery and introduced the synoptic operative reports (SORs). The standardization of SORs holds promise, but successful implementation requires strategies to address key implementation barriers. This study aimed to identify the barriers and facilitators to implementing breast SOR within diverse CoC-accredited programs. Methods: In-depth semi-structured interviews were conducted with 31 health care professionals across diverse CoC-accredited sites. The study used two comprehensive implementation frameworks to guide data collection and analysis. Results: Successful SOR implementation was impeded by disrupted workflows, surgeon resistance to change, low prioritization of resources, and poor flow of information despite CoC's positive reputation. Participants often lacked understanding of the requirements and timeline for breast SOR and were heavily influenced by prior experiences with templates and SOR champion relationships. The perceived lack of monetary benefits (to obtaining CoC accreditation) together with the significant information technology (IT) resource requirements tempered some of the enthusiasm. Additionally, resource constraints and the redirection of personnel during the COVID-19 pandemic were noted as hurdles. Conclusions: Surgeon behavior and workflow change, IT and personnel resources, and communication and networking strategies influenced SOR implementation. During early implementation and the implementation planning phase, the primary focus was on achieving buy-in and initiating successful roll-out rather than effective use or sustainment. These findings have implications for enhancing standardization of surgical cancer care and guidance of future strategies to optimize implementation of CoC accreditation standards. [ABSTRACT FROM AUTHOR]

Introduction: Older adults with chronic disease prioritize functional independence. We aimed to describe the feasibility of capturing functional disability and treatment toxicity among older adults with lung cancer using a longitudinal comprehensive geriatric assessment (CGA) and molecular biomarkers of aging. Methods: This prospective study included adults ≥60 years with any newly diagnosed non-small-cell lung cancer. Participants were recruited from central Ohio (2018–2020). Study assessments included the Cancer and Aging Research Group CGA (CARG-CGA), short physical performance battery (SPPB), and the blessed orientation-memory concentration (BOMC) test at baseline, 3, 6, and 12 months. Activities of daily living (ADLs) and instrumental ADLs (IADLs), quality of life (QoL, PROMIS 10), and treatment toxicity were captured monthly. Stool and blood were collected to characterize the gut microbiome and age)related blood biomarkers. Results: This study enrolled 50 participants with an average age of 71.7 years. Ninety-two percent of participants were Caucasian, 58% were male, and all were non-Hispanic. Most had advanced stage (stage III/IV: 90%; stage I/II: 10%), with adenocarcinoma the predominant histologic subtype (68% vs. 24% squamous). First-line treatments included chemotherapy (44%), immune checkpoint inhibitors (ICIs, 22%), chemotherapy and ICIs (30%), or tyrosine kinase inhibitors (4%). The median baseline CARG toxicity score was 8 (range 2–12). Among patients with treatment-related toxicity (n = 49), 39 (79.6%) cases were mild (grade 1–2), and 10 (20.4%) were moderate to severe (≥ grade 3). Treatment toxicity was greater among those with a CARG score ≥8 (28.0% vs. 13.6%). Higher IADL independence, QoL, and SPPB scores at baseline were positively associated with Candidatus Gastranaerophilales bacterium, Lactobacillus rogosae, and Enterobacteria phage P4. Romboutsia ilealis, Streptococcus, and Lachnoclostridium sp An138 and T cell lag3 and cd8a were associated with worse IADLs, QoL, and SPPB scores at baseline. Discussion: A longitudinal CGA and biomarker collection is feasible among older adults undergoing lung cancer treatment. Gut microbe and T cell gene expression changes correlated with subjective and objective functional status assessments. Future research will test causality in these associations to improve outcomes through novel supportive care interventions to prevent functional disability. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between various sociodemographic factors with alcohol and tobacco use behaviors during the COVID-19 pandemic. Methods: Participants from Ohio and Indiana were asked to participate in the 'Impact of COVID-19 on the Cancer Continuum Consortium' study (N = 32,989) from June–November 2020. Those who completed the survey and responded to key study questions were included (n = 5,374). Participants were asked about the frequency and type of alcohol and tobacco product used. Multivariable logistic regression was conducted to determine factors associated with the impact of COVID-19 on change in alcohol and/or tobacco use. Results: Mean age was 57 years old, 68% were female, 90% non-Hispanic white, 75% married, and 31% lived in rural counties. Out of 5,374 participants, 53% used alcohol-only (n = 2,833), 5% used tobacco-only (n = 255), 7% used both alcohol and tobacco (n = 395), and 35% used neither alcohol nor tobacco (n = 1,891). Urban county of residence (vs. rural) was associated with an increase in alcohol-use (p = 0.0001), change in alcohol products (p = 0.023), and an increase in tobacco use (p = 0.05). Among alcohol-only users, those who were younger (OR = 0.97), female (OR = 1.58), married (OR = 1.69), of high socioeconomic status (OR = 1.99), residing in urban counties (OR = 1.65), and had elevated financial (OR = 1.06) and employment concerns (OR = 1.28) were significantly more likely to report increased alcohol-use. Similarly, among tobacco users, those who were younger (OR = 0.97), female (OR = 2.79), married (OR = 2.16) or divorced (OR = 2.83), and had higher levels of neighborhood disadvantage (OR = 2.19) were significantly more likely to report increased tobacco-use. Conclusions: Findings suggest targeted intervention and prevention strategies for young, female participants with elevated financial and employment concerns during the COVID-19 pandemic are necessary to mitigate risks associated with higher odds of alcohol and tobacco use. Our findings on alcohol and tobacco use may be a result of the unique social and economic influence of the pandemic on women. [ABSTRACT FROM AUTHOR]

Background Up to 50% of people scheduled for screening colonoscopy do not complete this test and no studies have focused on minority and low-income populations. Interventions are needed to improve colorectal cancer (CRC) screening knowledge, reduce barriers, and provide alternative screening options. Patient navigation (PN) and tailored interventions increase CRC screening uptake, however there is limited information comparing their effectiveness or the effect of combining them. Purpose Compare the effectiveness of two interventions to increase CRC screening among minority and low-income individuals who did not attend their screening colonoscopy appointment—a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based PN compared to usual care. Methods Patients (n = 371) aged 45–75 years at average risk for CRC who did not attend a screening colonoscopy appointment were enrolled and were randomized to: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. CRC screening outcomes were from electronic medical records at 12 months. Multivariable logistic regression analyses were used to study intervention effects. Results Participants randomized to tailored DVD plus PN were four times more likely to complete CRC screening compared to usual care and almost two and a half times more likely than those who were sent the DVD alone. Conclusions Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend their screening colonoscopy appointments and has potential for wide dissemination. [ABSTRACT FROM AUTHOR]

Summary: Background/Aims: We examined the effects of glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) initiation on long‐term Adverse Liver Outcomes (ALO) in patients with Metabolic Dysfunction‐Associated Steatotic Liver Disease (MASLD) cirrhosis and type 2 diabetes using real‐world data from the MarketScan database. Methods: We conducted a retrospective cohort study of patients with MASLD cirrhosis and type 2 diabetes between 2012 and 2020. Cox proportional hazard models examine the association between GLP‐1RAs initiation, modelled as time‐dependent, and the risk of ALO, a composite endpoint defined by the first occurrence of hepatic decompensation(s), portal hypertension, hepatocellular carcinoma (HCC) or liver transplantation (LT). We used Overlap Propensity Score Weighting (OPSW) to account for confounding. The study included 459 GLP‐1RAs and 4837 non‐GLP‐1RAs patients. Results: The non‐GLP‐1RAs patients presented with 1411 (29%) ALO over 7431.7 person years, while GLP‐1RAs patients had 32 (7%) ALO over 586.6 person years – risk rate difference 13.5 (95% CI: 11.4–15.7) per 100 person‐years. The OPSW‐adjusted risk of ALO was reduced by 36% (hazard ratio [HR]: 0.64; 95% CI: 0.54–0.76) in patients with vs. without GLP‐1RAs initiation. GLP‐1RAs initiation was associated with significant reductions in the adjusted risk of hepatic decompensation (HR: 0.74; 95% CI: 0.61–0.88), portal hypertension (HR: 0.73; 95% CI: 0.60–0.88), HCC (HR: 0.37; 95% CI: 0.20–0.63) and LT (HR: 0.24; 95% CI: 0.12–0.43). Conclusion: The use of GLP‐1RAs was associated with significant risk reductions in long‐term adverse liver outcomes, including hepatic decompensation, portal hypertension, HCC and LT, in MASLD cirrhosis patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background & aims: Previous studies have examined the effects of metabolic syndrome (MetS) rather than its severity on race and ethnic disparities in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). We used the MetS severity score, a validated sex-race-ethnicity-specific severity measure, to examine the effects of race/ethnicity on the association between MetS severity and MASLD. Methods: This study included 10,605 adult participants from the Third National Health and Nutrition Examination Survey. The MASLD diagnosis was based on ultrasound findings in patients without excessive alcohol intake or other liver diseases. MetS severity Z-scores were calculated and stratified into four categories low (1st-50th), moderate (>50th-75th), high (>75th-90th), and very high (>90th+)]. Multivariable adjusted logistic regression models with complex survey methods were used to test the effect of MetS severity on MASLD. Results: The age-adjusted MASLD prevalence was 17.4%, 25.7%, 42.5, and 54.9% in adults with mild, moderate, high, and very high MetS severities, respectively (P-trend <0.001). MetS severity was significantly higher in patients with MASLD than in those without [mean percentile 60th vs. 44th, P<0.001]. Among patients with MASLD, Mexican-American and Black non-Hispanic females had significantly higher age-adjusted MetS severity (68th and 61st, respectively) than White non-Hispanic females 54th, while Black non-Hispanic males had significantly lower MetS severity (56th) than White non-Hispanic males (70th) (P-Interaction = 0.02). Adults with high and very high MetS severity had 2.27 (95% CI:1.70 to 3.03) and 3.12 (95% CI:2.20 to 4.42), respectively, higher adjusted odds of MASLD than those with mild MetS severity. Conclusions: Racial/ethnic disparities in MetS severity play a pivotal role in the risk of MASLD. Our findings highlight the potential clinical utility of the MetS severity score in identifying at-risk individuals, which will help guide targeted prevention and tailoring management strategies to mitigate the MASLD burden. [ABSTRACT FROM AUTHOR]

Background: Identifying patient‐ and disease‐specific characteristics associated with clinical trial enrollment of adolescents and young adults (AYAs) with cancer may target efforts to improve accrual. Methods: Alliance for Clinical Trials in Oncology (Alliance) trials opened from January 1, 2000, and closed before January 1, 2018, for common AYA cancers were identified. Proportions of AYAs (aged 18–39 years old) versus non‐AYAs (aged ≥40 years old) enrolled by cancer type were summarized by descriptive statistics. Among studies with ≥20 AYAs enrolled, demographic and disease characteristics of AYAs versus non‐AYAs were compared with χ2 and Kruskal–Wallis tests. A qualitative review was also conducted of therapeutic trials included in analysis in PubMed through December 31, 2021, that reported AYA‐specific survival. Results: Among 188 trials enrolling 40,396 patients, AYAs represented 11% (4468 of 40,396) of accrual. AYA accrual varied by cancer type (leukemia, 23.6%; breast, 9.9%; lymphoma, 14.8%; colorectal, 6.2%; central nervous system, 8.1%; melanoma, 11.8%; sarcoma, 12%). Across ages, the proportion of Black and Hispanic patients enrolled was 1%–10%. Compared to non‐AYAs, AYAs in breast and colorectal cancer trials were less likely to be White and more likely to be Hispanic. Disease characteristics differed by age for selected trials. Two trials reported AYA‐specific survival, with no significant differences observed by age. Conclusions: AYA accrual to Alliance trials was comparable to or exceeded population‐based, age‐specific prevalence estimates for most cancer types. Greater proportional representation of Hispanic and non‐White patients among AYAs reflects US demographic trends. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs. Adolescent and young adult (AYA) patients represented 11% of overall accrual to Alliance for Clinical Trials in Oncology trials from 2000 to 2017, which was comparable to or exceeded population‐based, age‐specific prevalence estimates for most cancer types. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs. [ABSTRACT FROM AUTHOR]

Background: To understand the dynamics that limit use of risk-management options by women at high risk of breast cancer, there is a critical need for research that focuses on patient perspectives. Prior research has left important gaps: exclusion of high-risk women not in risk-related clinical care, exclusion of non-white populations, and lack of attention to the decision-making processes that underlie risk-management choices. Our objective was to create a more inclusive dataset to facilitate research to address disparities related to decision making for breast cancer risk management. Methods: The Daughter Sister Mother Project survey collects comprehensive information about the experiences of women at high risk of breast cancer. We collected novel measures of feelings about and reactions to cancer screenings; knowledge, barriers, and facilitators of risk-management options; beliefs related to cancer risk and risk management; and involvement with loved ones who had cancer. Eligible individuals were non-Hispanic white and non-Hispanic Black adult women who self-identified as having high risk of breast cancer and had no personal history of cancer. Between October 2018 and August 2019, 1053 respondents completed the online survey. Of these, 717 were confirmed through risk prediction modeling to have a lifetime breast cancer risk of ≥ 20%. Sociodemographic characteristics of this sample were compared to those of nationally representative samples of the US population: the 2019 Health Information National Trends Survey and the Pew Research Center report: Jewish Americans in 2020. Results: The sample of 717 women at objectively high risk of breast cancer was largely (95%) recruited from non-clinical sources. Of these respondents, only 31% had seen a genetic counselor, 34% had had genetic testing specific to breast cancer risk, and 35% had seen at least one breast or cancer care specialist. The sample includes 35% Black respondents and 8% with Ashkenazi Jewish ancestry. Although encompassing a substantial range of ages, incomes, and education levels, respondents are overall somewhat younger, higher-income, and more educated than the US population as a whole. Conclusions: The DSM dataset offers comprehensive data from a community-based, diverse sample of women at high risk of breast cancer. The dataset includes substantial proportions of Black and Ashkenazi Jewish women and women who are not already in clinical care related to their breast cancer risk. This sample will facilitate future studies of risk-management behaviors among women who are and are not receiving high-risk care, and of variations in risk-management experiences across race and ethnicity. [ABSTRACT FROM AUTHOR]

Purpose: The rising cost of breast cancer treatment has increased patients’ financial burden, intensifying an already stressful treatment process. Although researchers increasingly recognize the harmful impact of medical and nonmedical costs associated with cancer treatment, understanding patients’ perspectives of financial toxicity is limited. We aimed to explore the topic of financial toxicity through the lived experiences of patients with breast cancer from groups at risk of social and economic marginalization. Methods: We conducted semi-structured interviews with 50 women with breast cancer from four specific groups: Black women, Medicaid enrollees, rural residents, and women age ≤ 40. We transcribed, coded, and analyzed the data using deductive and inductive approaches. Results: Two overarching themes captured patients’ experiences of financial toxicity: short-term and long-term impacts. Short-term stressors included direct medical (e.g., co-pays, premiums), nonmedical (e.g., transportation, lodging), and indirect (e.g., job loss, reduced work hours) costs. Early in their treatments, patients’ focus on survival took precedence over financial concerns. However, as the treatment course progressed, fear of consequences from compounding costs of care and financial distress negatively impacted patients’ lifestyles and outlooks for the future. Conclusion: Programs addressing financial toxicity that look beyond early-phase interventions are needed. Specifically, patients struggling with the accumulation of treatment costs and the resultant stress require ongoing support. Long-term support is especially needed for groups vulnerable to financial instability and social marginalization. [ABSTRACT FROM AUTHOR]

Process evaluation is essential to understanding and interpreting the results of randomized trials testing the effects of behavioral interventions. A process evaluation was conducted as part of a comparative effectiveness trial testing a mailed, tailored interactive digital video disc (DVD) with and without telephone-based patient navigation (PN) to promote breast, cervical and colorectal cancer screening among rural women who were not up-to-date (UTD) for at least one screening test. Data on receipt, uptake, and satisfaction with the interventions were collected via telephone interviews from 542 participants who received the tailored interactive DVD (n = 266) or the DVD plus telephone-based PN (n = 276). All participants reported receiving the DVD and 93.0% viewed it. The most viewed sections of the DVD were about colorectal, followed by breast, then cervical cancer screening. Most participants agreed the DVD was easy to understand, helpful, provided trustworthy information, and gave information needed to make a decision about screening. Most women in the DVD+PN group, 98.2% (n = 268), reported talking with the navigator. The most frequently discussed cancer screenings were colorectal (86.8%) and breast (71.3%); 57.5% discussed cervical cancer screening. The average combined length of PN encounters was 22.2 minutes with 21.7 additional minutes spent on coordinating activities. Barriers were similar across screening tests with the common ones related to the provider/health care system, lack of knowledge, forgetfulness/too much bother, and personal issues. This evaluation provided information about the implementation and delivery of behavioral interventions as well as challenges encountered that may impact trial results. [ABSTRACT FROM AUTHOR]

Purpose: Obesity and health behaviors are the major modifiable contributors to cancer and health disparities. We examined the differences in obesity-related health behaviors, and health outcomes by rural and Appalachian residency in Ohio. Methods: Cross-sectional survey data from the 2011–2019 Behavioral Risk Factor Surveillance System were obtained from the Ohio Department of Health. County-level identifiers were used to classify urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian residency. Self-reported weight, height, health behaviors, and health conditions were used. Logistic regression was used to assess the difference in health behaviors and health outcomes by rural and Appalachian residency. All analyses incorporated with sample weights. Results: Among Ohio residents, compared to urban non-Appalachian residents, urban Appalachian and rural Appalachian residents had a higher prevalence of obesity, hypertension, high cholesterol, and cardiovascular diseases, as well as lower rates of healthy diet and physical activity. No difference was found in trends of obesity and obesity-related health outcomes in 2011–2019 by rural and Appalachian residency. However, rural Appalachian residents had a greater increase in obesity, hypertension, and diabetes, whereas rural non-Appalachian had favorable changes in obesity-related health behaviors. Additionally, associations between health behaviors and obesity-related health outcomes differed by rural and Appalachian residency. Conclusions: Findings underscore the importance of distinguishing between urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian populations when assessing health disparities. While the trends of obesity and obesity-related health outcomes did not differ, the association between health behaviors and obesity-related outcomes differed by rural and Appalachian residency. [ABSTRACT FROM AUTHOR]

Patient navigation (PN) was created to address barriers to screening and workup for cancers. Since its inception it has resulted in improved mammography utilization, diagnostic resolution, and time to breast cancer treatment initiation in medically underserved populations. Because an abundance of evidence has established PN's positive impact, its use has expanded within the breast cancer care continuum, from screening, treatment, and ultimately survivorship. Increasing applications for navigation now also include support in the treatment and survivorship phase. After treatment, populations who struggle with the complex medical systems where oncology care is often delivered, also lack the support resources needed to successfully transition to survivorship. Support in the psychosocial realm is important for these patients as they continue surveillance and adherence to maintenance medications, such as hormonal therapy. [ABSTRACT FROM AUTHOR]

Purpose: We examined longitudinal trends and factors associated with insomnia over 3 years in a cohort of young breast cancer patients. Methods: Women with stage I–III breast cancer at ≤ 45 years were recruited at five institutions from New York, Texas, and North Carolina, within 8 months of diagnosis (n = 836). Participants completed questionnaires every 6 months for 3 years. Linear mixed-effects models were used to examine insomnia over time, using the Women's Health Initiative Insomnia Rating Scale (WHIIRS). We evaluated the relations of insomnia with demographic (age, race, education, income, employment, marital status), clinical (cancer stage, histologic grade, chemotherapy, radiation, hormone therapy, surgery, tumor size, body mass index, hot flashes), and social/behavioral variables (smoking status, social support, physical activity, depressive symptoms). Results: At baseline, 57% of participants met or exceeded the cut-off for clinical insomnia (WHIIRS score ≥ 9). Insomnia symptoms were most prevalent at baseline (p < 0.0001), but decreased significantly throughout follow-up (p < 0.001). However, 42% of participants still experienced insomnia symptoms 3 years after diagnosis. In multivariable models, older age (p = 0.02), hot flashes (p < 0.0001), and depressive symptoms (p < 0.0001) remained significantly associated with insomnia over time. Conclusions: Insomnia symptoms were most frequent closer to breast cancer diagnosis and treatment, but persisted for some women who were older and those reporting higher hot flashes and depressive symptoms. Survivorship care should include assessing insomnia symptoms, particularly during and immediately after primary treatment. Implementing early interventions for sleep problems may benefit young breast cancer survivors and improve their quality of life. [ABSTRACT FROM AUTHOR]

Background: Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women. Methods: The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months. Discussion: This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods. Trial registration: Clinicaltrials.gov . Registered on 7 May 2020. [ABSTRACT FROM AUTHOR]

Background: Turning the Page on Breast Cancer (TPBC) uses a multilevel approach to reduce breast cancer (BC) mortality among Black women. TPBC intervenes by (1) improving health care facilities' ability to conduct effective BC screening, follow‐up, and treatment; (2) involving community‐based organizations; and (3) providing education and personal risk information through a culturally relevant website. Ohio has among the worst BC mortality rates in the United States for Black women. TPBC is in its third year of providing targeted interventions in 12 Ohio counties with particularly high BC rates among Black women. Methods: TPBC enrolls health care facilities, collects organizational and patient data, and conducts key informant interviews to inform the provision of appropriate evidence‐based interventions. TPBC engages Black communities through community‐based organizations and social media advertising. The TPBC website offers BC information, connects Black women to community BC resources, and provides access to a risk‐assessment tool. Results: TPBC has provided tailored information packets, evidence‐based interventions, and systematic support for improving the tracking and follow‐up of breast health care among patients in 10 clinical partnerships. The project has provided education at community events monthly since mid‐2021. The TPBC website (http://endbreastcancerohio.org) is promoted through social media (primarily Facebook) and community events to reach Black women aged 25–70 years. To date, 4108 unique users have visited the website, of whom 15.9% completed the risk assessment. Conclusions: Novel strategies are needed to address persistent disparities in BC outcomes among Black women. TPBC demonstrates the potential effectiveness of multiple methods of community‐based, clinic‐based, and web‐based engagement. Plain Language Summary: Turning the Page on Breast Cancer (TPBC) aims to reduce breast cancer mortality among Black women in Ohio by conducting multilevel, community‐engaged interventions in 12 counties.Women are provided risk information and education at virtual and in‐person community events and through a community‐friendly website that was launched in November 2020.Almost 4000 women have visited the website, which offers community‐targeted information, urges screening for individuals at elevated risk, and offers access to patient navigation services; 655 users have used a breast cancer risk‐assessment tool on the site.Community‐based organizations conduct educational efforts.TPBC partners with health care facilities, which are taught to improve their ability to conduct effective breast cancer screening, follow‐up, and treatment.So far, TPBC has provided educational information, evidence‐based intervention lists, tailored information packets, and ongoing quarterly support to partners in 10 counties.Evaluation will focus on aggregated data for screening and genetic testing referral at the clinic level. Novel strategies are needed to address persistent disparities in breast cancer outcomes among Black women. Community‐based and social media‐based strategies have potential to facilitate web‐based engagement, personalized risk assessment and breast health prescriptions, screening, and referrals. [ABSTRACT FROM AUTHOR]

Appalachian regions of Kentucky and Ohio are hotspots for colorectal cancer (CRC) mortality in the USA. Screening reduces CRC incidence and mortality; however, screening uptake is needed, especially in these underserved geographic areas. Implementation science offers strategies to address this challenge. The aim of the current study was to conduct multi-site, transdisciplinary research to evaluate and improve CRC screening processes using implementation science strategies. The study consists of two phases (Planning and Implementation). In the Planning Phase, a multilevel assessment of 12 health centers (HC) (one HC from each of the 12 Appalachian counties) was conducted by interviewing key informants, creating community profiles, identifying HC and community champions, and performing HC data inventories. Two designated pilot HCs chose CRC evidence-based interventions to adapt and implement at each level (i.e. patient, provider, HC, and community) with evaluation relative to two matched control HCs. During the Implementation Phase, study staff will repeat the rollout process in HC and community settings in a randomized, staggered fashion in the remaining eight counties/HCs. Evaluation will include analyses of electronic health record data and provider and county surveys. Rural HCs have been reluctant to participate in research because of concerns about capacity; however, this project should demonstrate that research does not need to be burdensome and can adapt to local needs and HC abilities. If effective, this approach could be disseminated to HC and community partners throughout Appalachia to encourage the uptake of effective interventions to reduce the burden of CRC. [ABSTRACT FROM AUTHOR]

Introduction: Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. Methods: We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. Results: Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. Conclusion: We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research. [ABSTRACT FROM AUTHOR]

Purpose: Due to cancer survivors living longer and morbidity associated with cancer treatments, it is necessary to understand symptoms experienced by cancer survivors. This study will analyze the symptom burden among a large cohort of survivors across multiple cancer sites. Methods: Data from the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study were used to examine the symptom burden of older cancer survivors. Poisson regression with robust standard errors was utilized to determine differences in symptoms by cancer site, treatment, and other covariates. Results: The most frequently reported symptoms among cancer survivors were fatigue (15.8%) and feeling sad or depressed (14.1%). Multivariable analyses indicated that more symptoms were reported among survivors who were younger (p = 0.002), divorced or separated (p = 0.03), and had a combination of public and private insurance (p = 0.01). Survivors who received chemotherapy (p < 0.001), radiation (p = 0.01), or hormone therapy (p = 0.02) reported more symptoms than survivors who did not receive these treatments. Survivors diagnosed with cancer < 5 years ago reported fewer symptoms than longer-term survivors, particularly those diagnosed > 10 years ago (p = 0.02). Conclusions: Results indicate that common physical and psychological symptoms are reported across cancer types. Cancer survivors diagnosed with cancer 10 or more years ago reported more symptoms than those recently diagnosed. This suggests that symptoms may remain a problem for some survivors decades after their diagnosis. Implications for Cancer Survivors: Future research should focus on implementing active surveillance of cancer survivors. Healthcare providers and those who care for cancer survivors should understand that the symptom burden associated with cancer may persist even decades following diagnosis. [ABSTRACT FROM AUTHOR]

Rural residents experience higher rates of obesity, obesity-related chronic diseases, and poorer lifestyle. Promoting physical activity and healthy eating are critical for rural residents; however, lack of resources and access barriers limit the feasibility of in-person lifestyle interventions. There is a need to design and deliver remotely accessible lifestyle interventions in this population. This pilot study examined the effect of a telephone-based lifestyle intervention on weight, body composition, lipids, and inflammatory biomarkers among rural Ohio residents. Rural Ohio adults with overweight/obesity (n = 40) were 2:1 randomized to a 15-week telephone-based lifestyle intervention (n = 27) or control group (n = 13). The lifestyle intervention group received weekly telephone counseling sessions emphasizing healthy eating and increasing physical activity. The control group received educational brochures describing physical activity and dietary recommendations. Weight, body composition, fasting blood lipids, and inflammatory biomarkers were objectively measured at baseline and 15 weeks at local community centers (trial registration#: NCT05040152 at ClinicalTrial.gov). Linear mixed models were used to examine change over time by group. Participants were mostly female, with an average age of 49 years. Over the 15-week trial, the lifestyle intervention showed superior improvements in total cholesterol (∆ = −18.7 ± 7.8 mg/dL, p = 0.02) and LDL (∆ = −17.1 ± 8.1 mg/dL, p = 0.04) vs. control, whereas no significant between-group differences in weight, body composition, or inflammation were observed. Our findings suggest that a 15-week telephone-based lifestyle intervention may offer metabolic benefits that reduce disease risk in rural adults with obesity. Future large-scale studies are needed to determine the efficacy of remotely accessible lifestyle interventions in rural populations, with the goal of reducing obesity-related disparities. [ABSTRACT FROM AUTHOR]

Background: Turning the Page on Breast Cancer (TPBC) uses a multilevel approach to reduce breast cancer (BC) mortality among Black women. TPBC intervenes by (1) improving health care facilities' ability to conduct effective BC screening, follow‐up, and treatment; (2) involving community‐based organizations; and (3) providing education and personal risk information through a culturally relevant website. Ohio has among the worst BC mortality rates in the United States for Black women. TPBC is in its third year of providing targeted interventions in 12 Ohio counties with particularly high BC rates among Black women. Methods: TPBC enrolls health care facilities, collects organizational and patient data, and conducts key informant interviews to inform the provision of appropriate evidence‐based interventions. TPBC engages Black communities through community‐based organizations and social media advertising. The TPBC website offers BC information, connects Black women to community BC resources, and provides access to a risk‐assessment tool. Results: TPBC has provided tailored information packets, evidence‐based interventions, and systematic support for improving the tracking and follow‐up of breast health care among patients in 10 clinical partnerships. The project has provided education at community events monthly since mid‐2021. The TPBC website (http://endbreastcancerohio.org) is promoted through social media (primarily Facebook) and community events to reach Black women aged 25–70 years. To date, 4108 unique users have visited the website, of whom 15.9% completed the risk assessment. Conclusions: Novel strategies are needed to address persistent disparities in BC outcomes among Black women. TPBC demonstrates the potential effectiveness of multiple methods of community‐based, clinic‐based, and web‐based engagement. Plain Language Summary: Turning the Page on Breast Cancer (TPBC) aims to reduce breast cancer mortality among Black women in Ohio by conducting multilevel, community‐engaged interventions in 12 counties.Women are provided risk information and education at virtual and in‐person community events and through a community‐friendly website that was launched in November 2020.Almost 4000 women have visited the website, which offers community‐targeted information, urges screening for individuals at elevated risk, and offers access to patient navigation services; 655 users have used a breast cancer risk‐assessment tool on the site.Community‐based organizations conduct educational efforts.TPBC partners with health care facilities, which are taught to improve their ability to conduct effective breast cancer screening, follow‐up, and treatment.So far, TPBC has provided educational information, evidence‐based intervention lists, tailored information packets, and ongoing quarterly support to partners in 10 counties.Evaluation will focus on aggregated data for screening and genetic testing referral at the clinic level. Novel strategies are needed to address persistent disparities in breast cancer outcomes among Black women. Community‐based and social media‐based strategies have potential to facilitate web‐based engagement, personalized risk assessment and breast health prescriptions, screening, and referrals. [ABSTRACT FROM AUTHOR]

Background: The impacts of socioeconomic status (SES) on COVID-19-related changes in cancer prevention behavior have not been thoroughly investigated. We conducted a cohort study to examine the effects of SES on changes in cancer prevention behaviors during the COVID-19 pandemic. Methods: We invited adult participants from previous studies conducted at Ohio State University to participate in a study assessing the impact of COVID-19 on various behaviors. Post-COVID-19 cancer prevention behaviors, including physical activity, daily intake of fruits and vegetables, alcohol and tobacco consumption, and qualitative changes in post-COVID-19 behaviors relative to pre-COVID levels, were used to construct a prevention behavior change index that captures the adherence status and COVID-related changes in each behavior, with higher index scores indicating desirable changes in prevention behaviors. Participants were classified into low, middle, or high SES based on household income, education, and employment status. Adjusted regression models were used to examine the effects of SES on changes in cancer prevention behaviors during the COVID-19 pandemic. Results: The study included 6,136 eligible participants. The average age was 57 years, 67% were women, 89% were non-Hispanic Whites, and 33% lived in non-metro counties. Relative to participants with high SES, those with low SES had a 24% [adjusted relative ratio, aRR = 0.76 (95%CI 0.72–0.80)], 11% [aRR = 0.89 (95%CI 0.86–0.92)], and 5% [aRR = 0.95 (95%CI 0.93–0.96)], lower desirable changes in prevention behaviors for physical activity, fruit and vegetable intake, and tobacco use, respectively. Low SES had a higher desirable change in alcohol consumption prevention behaviors, 16% [aRR = 1.16 (95%CI 1.13–1.19)] relative to high SES. The adjusted odds of an overall poor change in prevention behavior were adjusted odds ratio (aOR) 1.55 (95%CI 1.27 to 1.89) and aOR 1.40 (95%CI 1.19 to 1.66), respectively, higher for those with low and middle SES relative to those with high SES. Conclusion: The adverse impacts of COVID-19 on cancer prevention behaviors were seen most in those with lower SES. Public health efforts are currently needed to promote cancer prevention behaviors, especially amongst lower SES adults. [ABSTRACT FROM AUTHOR]

Objective: To determine the relationship between family history of cancer with cancer attitudes and beliefs (CABs) and cancer screening knowledge. Methods: This study used data collected for the Community Initiative Towards Improving Equity and Health Status (CITIES) project which surveyed Ohioans ages 21–74. In the current analysis, we included data on age, gender, race, marital status, education, income, financial security, health insurance, CABs, knowledge about the correct age to begin cancer screenings, and presence of a first-degree relative with cancer. Multivariable logistic regression was used to examine the association of family history of cancer with CABs and knowledge about the correct age to begin cancer screening. Results: Participants were predominantly over the age of 41, female, and white. Out of 603 participants, 295 (48.92%) reported not having a first-degree relative with cancer and 308 (51.08%) reported having a first-degree relative with cancer. Overall, 109 (18.08%) participants reported negative CABs, 378 (62.69%) reported moderate CABs, and 116 (19.24%) reported positive CABs. Participants who reported a first-degree relative with cancer were more likely to report positive CABs, but the association was not significant (p =.11). We observed that older, more educated, and married participants were more likely to have positive CABs (all p < 0.05). Family history of cancer was not associated with differences in knowledge about the correct age for beginning colorectal cancer screening (p =.85) and mammography (p =.88). Conclusions: Having a first-degree relative with cancer was not found to be associated with CABs or knowledge about cancer screening. However, age and socioeconomic status were associated with more positive CABs and increased knowledge about cancer screening. Future research should focus on standardizing a CABs scale and expanding the generalizability of our findings. [ABSTRACT FROM AUTHOR]

Background Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative. Methods We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation. Results ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs. Conclusions Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: Older survivors of leukemia and lymphoma often experience long-term effects of chemotherapy. We described common concerns related to their cancer and treatment in older survivors of leukemia and non-Hodgkin lymphoma (NHL) and assessed correlates of these concerns. Methods: We utilized data from the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study that recruited post-menopausal women aged 50–79. Participants diagnosed with leukemia and NHL were included (n = 420). They were asked about 14 areas of current concerns related to their cancer and treatment and to rate each from 0 (no concern) to 2 (major concern), with total scores ranging from 0 to 28. Linear regression was used to assess factors correlated with the concern score, and logistic regression for factors correlated with the three most common concerns. Results: Mean age at assessment was 81 years (range 69–99); 72% reported at least one concern, and median concern score among these survivors was 3.5 (Q1–Q3 2–5). Factors significantly correlated with concern scores were sadness, pain, distress, higher prior symptom count, and loneliness (all p < 0.05). Significant factors correlated with common concerns were (1) fatigue/sleep: sadness/depression, distress, higher prior symptom count, greater loneliness, and worse physical functioning; (2) physical functioning/activity: older age, public insurance, higher body mass index, pain, worse QoL, and higher treatment-related comorbidities; (3) memory/concentration: prior chemotherapy or radiation, worse QoL, higher prior symptom count, and greater loneliness (all p < 0.05). Conclusions and Implications for Cancer Survivors: Almost three-quarters of older survivors of leukemia and lymphoma reported at least one concern; a multifaceted intervention may be needed to address these concerns. [ABSTRACT FROM AUTHOR]

Purpose: Colorectal cancer (CRC) survivors often experience long-term symptoms after cancer treatments. But gastrointestinal (GI) symptom experiences are under-investigated in CRC survivors. We described persistent GI symptoms after cancer treatments in female CRC survivors and assessed GI symptoms' risk and life-impact factors. Methods: A cross-sectional study utilized data from the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study that recruited postmenopausal women. Correlation analyses and multivariable linear regression models were used. Results: CRC survivors after cancer treatments were included (N = 413, mean age 71.2 years old, mean time since diagnosis = 8.1 years). 81% of CRC survivors experienced persistent GI symptoms. Bloating/gas was the most prevalent (54.2%± 0.88) and severe GI symptom, followed by constipation (44.1%±1.06), diarrhea (33.4%±0.76), and abdominal/pelvic pain (28.6%±0.62). Significant risk factors for GI symptoms include time since cancer diagnosis (<5 years), advanced cancer stage, high psychological distress, poor dietary habits, and low physical activity. Fatigue and sleep disturbance were the most significant risk factors for long-term GI symptoms (β = 0.21, t = 3.557; β = 0.20, t = 3.336, respectively, Ps <.001). High severity of GI symptoms was positively associated with poor quality of life (QOL), increased daily life interferences (social and physical functions), and low body image satisfaction (Ps <.001). Conclusions: Women CRC survivors experience a high GI symptom burden, highlighting the need to inform policy and improve the QOL of cancer survivors. Our findings will aid in identifying those more vulnerable to symptoms, and inform future survivorship care interventions (i.e., community-based cancer symptom management) by considering multiple risk factors (e.g., psychological distress). [ABSTRACT FROM AUTHOR]

The Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study is an excellent resource for studying the quality of life following breast cancer treatment. At study entry, women were asked about new symptoms that appeared following their initial cancer treatment. In this article, we were interested in using regression modeling to estimate associations of clinical and lifestyle factors at cancer diagnosis (independent variables) with the number of new symptoms (dependent variable). Although clinical and lifestyle data were collected longitudinally, few measurements were obtained at diagnosis or at a consistent timepoint prior to diagnosis, which complicates the analysis. Furthermore, parametric count models, such as the Poisson and negative binomial, do not fit the symptom data well. Thus, motivated by the issues encountered in LILAC, we propose two Bayesian joint models for longitudinal data and a count outcome. Our two models differ according to the assumption on the outcome distribution: one uses a negative binomial (NB) distribution and the other a nonparametric rounded mixture of Gaussians (RMG). The mean of each count distribution is dependent on imputed values of continuous, binary, and ordinal variables at a time point of interest (e.g. diagnosis). To facilitate imputation, longitudinal variables are modeled jointly using a linear mixed model for a latent underlying normal random variable, and a Dirichlet process prior is assigned to the random subject-specific effects to relax distribution assumptions. In simulation studies, the RMG joint model exhibited superior power and predictive accuracy over the NB model when the data were not NB. The RMG joint model also outperformed an RMG model containing predictors imputed using the last value carried forward, which generated estimates that were biased toward the null. We used our models to examine the relationship between sleep health at diagnosis and the number of new symptoms following breast cancer treatment in LILAC. [ABSTRACT FROM AUTHOR]

While biomarkers have been proposed to identify individuals at risk for radiation-induced cardiovascular disease (RICVD), little is known about long-term associations with cardiac events. We examined associations of biomarkers of oxidative stress (myeloperoxidase, growth differentiation factor-15, 8-hydroxy-2′-deoxyguanosine [8-OH-dG], placental growth factor), cardiac injury (troponin I, cystatin-C), inflammation (interleukin-6, C-reactive protein), and myocardial fibrosis (transforming growth factor-ß) with long-term RICVD in breast cancer (BC) survivors. We conducted a nested case–control study within the Women's Health Initiative of postmenopausal women with incident BC stages I–III, who received radiation and had pre- and post-BC diagnosis serum samples. Cases (n = 55) were defined as developing incident, physician-adjudicated myocardial infarction, coronary heart disease death, other CVD death, heart failure, or stroke after BC. Cases were matched to three controls (n = 158). After adjustment, a higher 8-OH-dG ratio was significantly associated with an elevated long-term risk of RICVD, suggesting oxidative DNA damage may be a putative pathway for RICVD. [ABSTRACT FROM AUTHOR]

Background: Adherence to COVID-19 protective measures is lowest for young people and males. The current study investigated characteristics associated with adherence to COVID-19 protective measures among male youth during the early months of the pandemic. Method: The study used data from a prospective cohort study among male youth with baseline assessment in 2015/2016 and follow-up measurements in 2019 and summer 2020. Attrition-weighted multivariable ordinal logistic and log-binomial regression models were used to assess factors associated with adherence to overall and specific adherence measures, respectively. Results: Among 571 male youth (mean age 18.5), overall adherence was higher for those who were older (OR: 1.15; 95% CI: 1.03–1.30), non-White (OR: 1.96; 95% CI: 1.20–3.32), and residing in an urban area (OR: 2.06; 95% CI: 1.46–3.01). Overall adherence was lower for those who had a history of being drunk (OR: 0.65; 95% CI: 0.42–0.99). For outdoor mask-wearing, adherence was higher for youth with attention-deficit disorder or attention-deficit/hyperactivity disorder (RR: 1.58; 95% CI: 1.16–1.97) and lower for youth who currently used tobacco products (RR: 0.42; 95% CI: 0.21–0.70). Before a statewide mask mandate was issued, non-White youth were more likely to report wearing masks in outdoor spaces than their non-Hispanic White peers (RR: 2.34; 95% CI: 1.75–3.23). Conclusion: The study identified demographic, psychosocial, and behavioral factors associated with adherence to COVID-19 protective behaviors among male youth. The findings illustrate characteristics that could be leveraged for targeted preventive efforts during the ongoing pandemic and future outbreaks in a low-compliance group. [ABSTRACT FROM AUTHOR]

Background: Weight loss through lifestyle modification can produce health benefits and may reduce cancer risk. The goal of this study was to examine the feasibility of and adherence to a 15-week telephone-based weight loss intervention in rural Ohio, an area with high rates of obesity. Methods: This pilot 2-arm randomized controlled study was designed for rural Ohio residents who were overweight or obese. Eligible participants were 2:1 randomly assigned to either a 15-week weight loss intervention group or active control group. The weight loss intervention group received weekly telephone sessions to improve healthy diet and increase physical activity. The active control group received education brochures with information on physical activity and dietary guidelines. Feasibility was defined as at least 80% of participants completing the follow-up surveys, and acceptable adherence was defined as the percentage of participants in the weight loss group who attend ≥75% of weekly telephone sessions. Results: A total of 423 individuals entered the online screening survey, 215 (50.8%) completed the survey, and 98 (45.6%) of those were eligible. Forty eligible individuals were enrolled and randomly assigned to the weight loss group (n = 27) or active control group (n = 13). The average age of the weight loss group was 49 (SD = 10) years, and 89% were female. The average age of the active control group was 51 (SD = 9) years, and 92% were female. Feasibility was demonstrated: 90% of participants completed the online follow-up surveys at 15-weeks. Among participants in the weight loss group, 22 out of 27 (81.5%) completed the 15-week intervention, the average number of sessions attended was 9.7 (64.9%). Adherence to the intervention was rated as acceptable among almost half of the group (48.1%). Conclusions: Feasibility of a 15-week telephone-based weight loss study among rural residents with overweight/obesity were determined. A future study will test this intervention for weight loss efficacy. [ABSTRACT FROM AUTHOR]

Purpose: Women at high risk of breast cancer face complex decisions about how to manage those risks. Substantial gaps in current knowledge include how women make these decisions and how decision making may differ across sub-populations. Among these critical gaps are the questions of (a) whether racial differences exist between the experiences of high-risk women navigating breast cancer risk, and (b) what consequences those racial differences might have on women's ability to manage their cancer risks. The present study is designed to address these questions directly. Methods: Fifty semi-structured interviews were conducted with high-risk Black (n = 20) and white women (n = 30) between May 2015 and March 2016 in person in Ohio and by phone. Transcribed data were analyzed using grounded theory methods. Main findings: Our analyses suggest that many of the core decision-making dynamics high-risk women navigate differ by race. The experiences of white and Black women in our study differ in terms of (a) contextualizing risk—how women make sense of their own breast cancer risk, the degree to which they worry about risk, and how they prioritize risk within the contexts of their broader lives; (b) conceptualizing risk management–how, how much, and from whom women learn about and conceptualize their options for preventing cancer and/or ensuring that cancer gets diagnosed early; and (c) constraints–the external barriers women face throughout their decision-making and risk-management processes. In sum, the Black women we interviewed reported feeling less well-situated to consider and cope actively with breast cancer risk, less well-informed about risk-management options, and more constrained in their use of these options. Conclusions: High-risk women's accounts of the complex dynamics that shape breast cancer prevention decisions suggest that these dynamics vary substantially by race, such that Black women may experience disadvantages relative to whites. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, enforced social distancing initiatives have highlighted differences in social distancing practices and the resulting loneliness in various populations. The objective of this study was to examine how cancer history and social distancing practices relate to loneliness during COVID-19. Methods and findings: Participants from previous studies (N = 32,989) with permission to be re-contacted were invited to complete a survey online, by phone, or by mail between June and November 2020. Linear and logistic regression models were used to determine the associations between cancer history, social distancing, and loneliness. Results: Among the included participants (n = 5729), the average age was 56.7 years, 35.6% were male, 89.4% were White, and 54.9% had a cancer history (n = 3147). Individuals with a cancer history were more likely to not contact people outside of their household (49.0% vs. 41.9%, p<0.01), but were less likely to feel lonely (35.8% vs. 45.3%, p<0.0001) compared to those without a cancer history. Higher adherence to social distancing behaviors was associated with higher odds of loneliness among individuals with (OR = 1.27, 95% CI: 1.17-1.38) and without a cancer history (OR = 1.15, 95% CI: 1.06-1.25). Conclusions: Findings from this study can inform efforts to support the mental health of individuals susceptible to loneliness during the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: A national priority in the United States is to promote patient engagement in cancer genomics research, especially among diverse and understudied populations. Several cancer genomics research programs have emerged to accomplish this priority, yet questions remain about the meaning and methods of patient engagement. This study explored how cancer genomics research programs define engagement and what strategies they use to engage patients across stages in the conduct of research. Methods: An environmental scan was conducted of cancer genomics research programs focused on patient engagement. Research programs were identified and characterized using materials identified from publicly available sources (e.g., websites), a targeted literature review, and interviews with key informants. Descriptive information about the programs and their definitions of engagement, were synthesized using thematic analysis. The engagement strategies were synthesized and mapped to different stages in the conduct of research, including recruitment, consent, data collection, sharing results, and retention. Results: Ten research programs were identified, examples of which include the Cancer Moonshot Biobank, the MyPART Network, NCI-CONNECT, and the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. All programs aimed to include understudied or underrepresented populations. Based on publicly available information, four programs explicitly defined engagement. These definitions similarly characterized engagement as being interpersonal, reciprocal, and continuous. Five general strategies of engagement were identified across the programs: 1) digital (such as websites) and 2) non-digital communications (such as radio broadcasts, or printed brochures); 3) partnering with community organizations; 4) providing incentives; and 5) affiliating with non-academic medical centers. Digital communications were the only strategy used across all stages of the conduct of research. Programs tailored these strategies to their study goals, including overcoming barriers to research participation among diverse populations. Conclusion: Programs studying cancer genomics are deeply committed to increasing research participation among diverse populations through patient engagement. Yet, the field needs to reach a consensus on the meaning of patient engagement, develop a taxonomy of patient engagement measures in cancer genomics research, and identify optimal strategies to engage patients in cancer genomics. Addressing these needs could enable patient engagement to fulfill its potential and accelerate the pace of cancer genomic discoveries. [ABSTRACT FROM AUTHOR]

Purpose: This study examined associations between self-reported cognitive functioning and social support as well as social ties among women with breast cancer. Methods: The study included 3351 women from the Women’s Health Initiative Life and Longevity After Cancer cohort who were diagnosed with breast cancer stages I–III. Social support was assessed using a modified Medical Outcomes Study (MOS) Social Support Survey, and marital status was obtained from the baseline questionnaire. We also assessed social ties (e.g., number of friends, relatives, living children) and cognitive function (Functional Assessment of Cancer Therapy-Cognitive Function [FACT-COG]) on the year-1-follow up questionnaire. Multivariable quantile regression was used to estimate the changes in median cognitive scores. Kruskal–Wallis tests were used to assess the association of cognitive function with social ties. Results: The majority of participants were non-Hispanic White (93.3%), presently married (49%), with at least a 4-year college degree (53.2%), and had been diagnosed with localized breast cancer (79%). A 10-point higher social support score correlated to a 0.32 higher (better) median cognitive score (p < 0.001). Women who were presently married tended to have better cognition than women who were divorced/separated or widowed (p = 0.01). Significant associations were also present for having close relatives (p < 0.001) or friends (p < 0.001), with cognitive scores being higher in those with at least one close relative or friend compared to none. Conclusion: Women reporting higher social support and greater numbers of friends or relatives have higher cognitive functioning. Compared to divorced or separated women, married women were likely to have higher cognitive functioning. These findings suggest that social support assessments have the potential to help identify women at higher risk of cognitive decline. [ABSTRACT FROM AUTHOR]

Purpose: Black women have higher breast cancer mortality rates than other groups, with Triple-negative breast cancer (TNBC) being more common among AAs with a worse prognosis. Our study seeks to explore differences among Non-Hispanic Black (NHB) vs. White (NHW) women, with Stage IV TNBC, focusing on survival and treatment patterns. Methods: SEER database was queried for TNBC patients diagnosed with metastatic disease from 2012 to 2016. Neighborhood socioeconomic status (nSES) was defined using the Yost index based on income, education, housing, and employment. Univariate and multivariate analyses were performed to evaluate receipt of surgery, radiation, and chemotherapy. Overall survival was evaluated using Kaplan–Meier curve and Cox proportional hazards model analysis. Results: 25,761 TNBC cases were identified with 1420 being metastatic (5.5%). Bone was the most common site for metastasis, with patients' age being 63.7 years for NHW vs. 59.5 years for NHB. NHB women had the highest percentage of low nSES (62.3% vs 29.3%; p value = 0.001). On univariate analysis, fewer NHBs received radiation compared to NHWs (27.1 vs. 32.6%; p value = 0.040). On multivariate analysis, all women were less likely to undergo treatment if unmarried (p value < 0.01). NHB women had lower median survival compared to NHW women (13 vs. 15 months; p value < 0.01). Receipt of surgery and chemotherapy reduced the risk of mortality (p value < 0.01). Conclusion: NHB women had lower median survival with metastatic TNBC. Race was associated with different treatment utilization. With a mortality differential between NHW and NHB women with metastatic TNBC, more investigation is needed to inform strategies to reduce this disparity. [ABSTRACT FROM AUTHOR]

Purpose: Studies examining biomarkers associated with fatigue in breast cancer survivors treated with radiation are limited. Therefore, we examined the longitudinal association between serum biomarkers and post-breast cancer fatigue in survivors treated with radiation: [oxidative stress] 8-hydroxyguanosine, myeloperoxidase; [inflammation] interleukin-6 (IL-6), c-reactive protein, growth differentiation factor-15 (GDF-15), placental growth factor, transforming growth factor-beta, [cardiac damage] cystatin-C, troponin-I. Methods: In a secondary analysis, we included participants from the Women's Health Initiative if they had: a previous breast cancer diagnosis (stages I-III), no prior cardiovascular diseases, pre-and post-breast cancer serum samples drawn approximately 3 years apart, and fatigue measured using the Short-Form 36 vitality subscale at both serum collections. Biomarkers were measured using ELISA or RT-qPCR and modeled as the log2 post-to pre-breast cancer ratio. Results: Overall, 180 women with a mean (SD) age of 67.0 (5.5) years were included. The mean (SD) vitality scores were 66.2 (17.2) and 59.7 (19.7) pre- and post-breast cancer, respectively. Using multivariable weighted linear regression, higher biomarker ratios of cystatin-C, IL-6, and GDF-15 were associated with a lower vitality score (i.e., higher fatigue). For example, for each 2-fold difference in cystatin-C biomarker ratio, the vitality score was lower by 7.31 points (95% CI: −14.2, −0.45). Conclusion: Inflammatory and cardiac damage biomarkers are associated with fatigue in breast cancer survivors treated with radiation; however, these findings should be replicated in a larger sample. Biomarkers could be measured in clinical practice or assessed in risk prediction models to help identify patients at high risk for fatigue. [ABSTRACT FROM AUTHOR]

Purpose: We investigated the association of coffee and caffeine with breast cancer (BCa) risk, overall and by ER/PR status. We also examined potential interactions of coffee and caffeine with postmenopausal hormone use. Methods: Our study included 77,688 postmenopausal participants from the Women's Health Initiative observational study cohort without a history of any cancer at baseline (except non-melanoma skin) and with valid Food Frequency Questionnaire data and complete data on dietary caffeine. Regular coffee (none, 1, 2–3, 4–5, and ≥ 6 cups/day) and caffeine (tertiles) were assessed at baseline. Information on BCa risk factors was collected at baseline. The associations were examined using survival analysis, accounting for death as a competing risk. Results: The median follow-up time for our cohort was 18.3 years. During the follow-up, 5005 women developed invasive breast cancer. In multivariable analysis, coffee was not associated with the overall invasive BCa risk. Higher caffeine intake was mildly associated with increased BCa risk (2nd vs. 1st tertile SHR = 1.10, 95% CI 1.03–1.18, 3rd vs. 1st tertile SHR–1.05, 95% CI 0.98–1.13, overall p = 0.03). We found no interaction of coffee/caffeine with postmenopausal hormone use (p interaction = 0.44 and 0.42, respectively). In the exploratory analysis by ER/PR status, we found a positive association of caffeine with ER+ /PR+ BCa (2nd vs. 1st tertile SHR = 1.17, 95% CI 1.07–1.28, 3rd vs. 1st tertile SHR = 1.13, 95% CI 1.03–1.24, overall p = 0.002); no associations were observed for ER−/PR− tumors. Coffee was not associated with the risk of ER+ /PR+ or ER−/PR− tumors. Conclusion: We found no associations of coffee with BCa risk, overall and for ER/PR-defined tumor subtypes. The higher caffeine consumption was mildly and positively associated with the overall BCa risk and with ER+ /PR+ tumors. [ABSTRACT FROM AUTHOR]

Men, particularly those of underserved groups, bear a disproportionate cancer burden. Knowledge about cancer and screening is associated with adherence to screening guidelines. However it is possible that a correlation exists between an individual's education attainment and ability to gain knowledge from health education. Men were recruited from Ohio counties with significant cancer disparities and asked to participate in three education sessions. Measures included a baseline survey collecting demographic information and pre- and post-intervention knowledge assessments about each of the topics. Paired t tests were used to determine whether there were statistically significant changes in mean scores after the intervention. Repeated measures of variance (ANOVA) conducted through generalized linear models (GLM) were used to determine if scores varied significantly by educational attainment. Appalachian men, regardless of level of educational attainment, had significant increases in knowledge for all topics. African American men with at least some college education demonstrated significant increases in knowledge for all three topics, while those with no college education had significant increases for only two topics. College education had a significant effect on scores for one topic among the Appalachian men and all three topics among the African American men. The interaction between change in score and higher educational attainment was significant for only one topic among Appalachian men and no topics among African American men. Higher educational attainment was associated with greater increases in knowledge scores for only one topic among Appalachian men and no topics among African American men. Culturally tailored health educational interventions are a promising approach to reducing disparities in cancer screening and outcomes among men of underserved groups. While all groups demonstrated increases in mean knowledge scores after participating in the educational intervention, there was not a significant association between educational attainment and increases in knowledge scores. Future research is needed to explore additional approaches to delivering health education and increasing the knowledge of men with lower levels of educational attainment. [ABSTRACT FROM AUTHOR]

A process evaluation was conducted as part of a comparative effectiveness trial of a mailed interactive educational DVD intervention to promote colorectal cancer screening among average-risk patients who did not attend a scheduled colonoscopy. Participants (n = 371) for the trial were randomized to (1) mailed DVD, (2) mailed DVD plus patient navigation, or (3) usual care. Participants (n = 243) randomized to the two DVD intervention arms were called 2 weeks after mailing materials to complete a process evaluation interview about the DVD (September 2017–February 2020). Forty-nine (20%) participants were not reached, and 194 (80%) participants watched the DVD and completed the interview. The process evaluation assessed whether (1) the DVD content was helpful, (2) any new information was learned by participants, (3) the appropriate amount of information was included in the DVD, (4) participants were engaged when watching the DVD, (5) the DVD content was relevant, (6) participants were satisfied with the DVD (7) participants would recommend the DVD to others, and (8) their opinion about colorectal cancer screening was changed by watching the DVD. Among participants who watched the DVD, 99% reported the screening information was very or somewhat helpful, 47% learned new information, 75% said the DVD included the right amount of information, they were engaged (M = 3.35 out of 4, SD = 0.49), 87% reported all or most information applied to them, they were satisfied (M = 3.42 out of 4, SD = 0.39) with DVD content, 99% would recommend the DVD to others, and 45% reported changing their opinion about screening. To understand the effects of interventions being tested in trials and to plan the dissemination of evidence-based interventions, process evaluation is critical to assess the dose received and acceptability of behavioral interventions. [ABSTRACT FROM AUTHOR]