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Background Racial disparities in the incidence of major cancers may be attributed to differences in the prevalence of established, modifiable risk factors such as obesity, smoking, physical activity and diet. Methods Data from a prospective cohort of 566,398 adults aged 50–71 years, 19,677 African-American and 450,623 Whites, was analyzed. Baseline data on cancer-related risk factors such as smoking, alcohol, physical activity and dietary patterns were used to create an individual adherence score. Differences in adherence by race, gender and geographic region were assessed using descriptive statistics, and Cox proportional hazards models were used to determine the association between adherence and cancer incidence. Results Only 1.5% of study participants were adherent to all five cancer-related risk factor guidelines, with marked race-, gender- and regional differences in adherence overall. Compared with participants who were fully adherent to all five cancer risk factor criteria, those adherent to one or less had a 76% increased risk of any cancer incidence (HR: 1.76, 95% CI: 1.70 – 1.82), 38% increased risk of breast cancer (HR: 1.38, 95% CI: 1.25 – 1.52), and doubled the risk of colorectal cancer (HR: 2.06, 95% CI: 1.84 – 2.29). However, risk of prostate cancer was lower among participants adherent to one or less compared with those who were fully adherent (HR: 0.79, 95% CI: 0.75 – 0.85). The proportion of cancer incident cases attributable to low adherence was higher among African-Americans compared with Whites for all cancers (21% vs. 19%), and highest for colorectal cancer (25%) regardless of race. Conclusion Racial differences in the proportion of cancer incidence attributable to low adherence suggests unique opportunities for targeted cancer prevention strategies that may help eliminate racial disparities in cancer burden among older US adults.

Background Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. Methods Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. Discussion Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. Trial registration ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.

Racial disparities in cancer mortality still exist despite improvements in treatment strategies leading to improved survival for many cancer types. In this study, we described race/ethnic differences in patterns of de novo metastasis and evaluated the association between site of de novo metastasis and breast, prostate, and colorectal cancer mortality. Data were obtained from the Surveillance Epidemiology and Ends Results (SEER) database from 2010 to 2013 and included 520,147 patients ages ≥40 years with primary diagnosis of breast, colorectal, or prostate cancer. Site and frequency of de novo metastases to four sites (bone, brain, liver, and lung) were compared by race/ethnicity using descriptive statistics, and survival differences examined using extended Cox regression models in SAS 9.4. Overall, non‐Hispanic (NH) Blacks (11%) were more likely to present with de novo metastasis compared with NH‐Whites (9%) or Hispanics (10%). Among patients with breast cancer, NH‐Blacks were more likely to have metastasis to the bone, (OR: 1.25, 95% CI: 1.15–1.37), brain (OR: 2.26, 95% CI: 1.57–3.25), or liver (OR: 1.62, 95% CI: 1.35–1.93), while Hispanics were less likely to have metastasis to the liver (OR: 0.76, 95% CI: 0.60–0.97) compared with NH‐Whites. Among patients with prostate cancer, NH‐Blacks (1.39, 95% CI: 1.31–1.48) and Hispanics (1.39, 95% CI: 1.29–1.49) were more likely to have metastasis to the bone. Metastasis to any of the four sites evaluated increased overall mortality by threefold (for breast cancer and metastasis to bone) to 17‐fold (for prostate cancer and metastasis to liver). Racial disparities in mortality remained after adjusting for metastasis site in all cancer types evaluated. De novo metastasis is a major contributor to cancer mortality in USA with racial differences in the site, frequency, and associated survival. Racial disparities in cancer mortality still exist despite improvements in treatment strategies leading to improved survival for many cancer types. Data from SEER 2010–2014 were utilized to assess racial/ethnic differences in site of de novo metastasis and relative survival associated with de novo metastasis by race/ethnicity. In conclusion, de novo metastasis is a major contributor to cancer mortality among patients with cancer in the USA.

Background We examined the association between metabolic dysregulation and cancer mortality in a prospective cohort of Black and White adults. Methods A total of 25,038 Black and White adults were included in the analysis. Metabolic dysregulation was defined in two ways: 1) using the joint harmonized criteria for metabolic syndrome (MetS) and 2) based on factor analysis of 15 variables characterizing metabolic dysregulation. We estimated hazards ratios (HRs) and 95% confidence intervals (CIs) for the association of MetS and metabolic dysregulation with cancer mortality during follow-up using Cox proportional hazards models. Results About 46% of Black and 39% of White participants met the criteria for MetS. Overall, participants with MetS (HR: 1.22, 95% CI: 1.03–1.45) were at increased risk of cancer-related death. In race-stratified analysis, Black participants with MetS had significantly increased risk of cancer mortality compared with those without MetS (HR: 1.32, 95% CI: 1.01–1.72), increasing to more than a 2-fold risk of cancer mortality among those with five metabolic syndrome components (HR: 2.35, 95% CI: 1.01–5.51). Conclusions There are marked racial differences in the prevalence of metabolic dysregulation defined as MetS based on the harmonized criteria. The strong positive associations between MetS and cancer mortality suggests that efforts to improve cancer outcomes in general, and racial disparities in cancer outcomes specifically, may benefit from prevention and management of MetS and its components.

Recruiting cancer survivors to research studies requires multiple steps that may be differentially challenging across groups of survivors. We examined associations between progression through recruitment steps and sociodemographic and clinical characteristics of survivors invited to participate in the Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) Cancer Survivor Health randomized control trial of web-based healthy lifestyle interventions. Survivors from two population-based cancer registries and a hospital registry (n = 23,270) were mailed an AMPLIFI invitation letter then called by recruiters. Outcomes included being (1) reached by recruiters, (2) screened for eligibility, (3) deemed eligible, and (4) consented. Bivariate and logistic regression analyses examined associations with sociodemographic and clinical factors. 7742 (33.3%) survivors were reached. Being reached was positively associated with being female, age 65+, African American, urban resident, and < 2 years from cancer diagnosis; negatively associated with colorectal cancer. Among those reached, 7438 were offered screening and 2278 (30.6%) were screened. Being screened was positively associated with being female, African American, and < 2 years from diagnosis; negatively associated with age 65+, resident in high disadvantage areas, survivor of colorectal cancer. Of survivors screened, 716 (32%) were eligible. Being eligible was positively associated with < 2 years from diagnosis; negatively associated with colorectal and kidney cancer. Of those eligible, 438(61.2%) consented to participate. Being consented was negatively associated with being African American and from high disadvantage areas. Outcomes across recruitment steps vary by survivors' characteristics indicating that opportunities exist for tailored approaches to promote greater overall diversity in clinical trials.

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. 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. 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. 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.

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

IntroductionLess than 40% of patients with ovarian cancer (OC) in the USA receive stage-appropriate guideline-adherent surgery and chemotherapy. Black patients with cancer report greater depression, pain and fatigue than white patients. Lack of access to healthcare likely contributes to low treatment rates and racial differences in outcomes. The Ovarian Cancer Epidemiology, Healthcare Access and Disparities study aims to characterise healthcare access (HCA) across five specific dimensions—Availability, Affordability, Accessibility, Accommodation and Acceptability—among black, Hispanic and white patients with OC, evaluate the impact of HCA on quality of treatment, supportive care and survival, and explore biological mechanisms that may contribute to OC disparities.Methods and analysisWe will use the Surveillance Epidemiology and Ends Results dataset linked with Medicare claims data from 9744 patients with OC ages 65 years and older. We will recruit 1641 patients with OC (413 black, 299 Hispanic and 929 white) from cancer registries in nine US states. We will examine HCA dimensions in relation to three main outcomes: (1) receipt of quality, guideline adherent initial treatment and supportive care, (2) quality of life based on patient-reported outcomes and (3) survival. We will obtain saliva and vaginal microbiome samples to examine prognostic biomarkers. We will use hierarchical regression models to estimate the impact of HCA dimensions across patient, neighbourhood, provider and hospital levels, with random effects to account for clustering. Multilevel structural equation models will estimate the total, direct and indirect effects of race on treatment mediated through HCA dimensions.Ethics and disseminationResult dissemination will occur through presentations at national meetings and in collaboration with collaborators, community partners and colleagues across othercancer centres. We will disclose findings to key stakeholders, including scientists, providers and community members. This study has been approved by the Duke Institutional Review Board (Pro00101872). Safety considerations include protection of patient privacy. All disseminated data will be deidentified and summarised.

Residents in persistent poverty areas experience higher cancer mortality due to social determinants of health that negatively affect multiple factors, including health behaviors. This study aimed to characterize demographic, clinical, and social determinant of health factors among survivors of cancer in persistent poverty areas using electronic health record (EHR) data-including an embedded social risk screener and natural language processing (NLP) of social work notes-to inform community-engaged adaptation of lifestyle interventions. EHR data from a large multispecialty group practice were extracted for patients with cancer residing in zip codes inclusive of persistent poverty areas targeted for a health behavior intervention and receiving care between January 2018 and November 2023. Self-reported social determinant of health data were obtained using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) and through NLP of social histories from a social work visit. We identified 2672 unique patients with cancer, of whom 578 (21.6%) had PRAPARE data and 1597 (59.8%) had social history data available for analysis. The most common cancers among survivors (n=1420, 53.1% female; n=1299, 48.6% Black individuals; mean age 65.2, SD 13.7 years) included breast (n=536, 20.1%), prostate (n=400, 15%), and lymphoid or hematopoietic (n=323, 12.1%) cancer. Among survivors in persistent poverty areas (n=509, 19%; all with a high Social Vulnerability Index), 34.6% (176/509) were single, 55.4% (282/509) had Medicare coverage (with only 73/509, 14.3% having private insurance), 36.5% (186/509) had obesity, 63.9% (325/509) had hypertension, and 31.2% (159/509) had diabetes. Of survivors in persistent poverty areas with PRAPARE data, 15.8% (19/120) lacked transportation, 4.2% (5/120) lived with housing insecurity, and 6.7% (8/120) felt unsafe where they lived. Innovative EHR and NLP approaches identified several socioeconomic and safety-related challenges along with opportunities for health behavior interventions to leverage Medicare coverage and target multiple comorbidities when adapting interventions for survivors of cancer living in persistent poverty areas.

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 ( E ducate, N urture, A dvise, B efore L ife E nds) 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.