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Backgrounds: Microbiome dysbiosis is an important contributing factor in tumor development and thus may be a risk predictor for human malignancies. In the United States, women with Hispanic/Latina (HIS) and African American (AA) background have a higher incidence of cervical cancer and poorer outcomes than Caucasian American (CA) women.Methods: Here, we assessed the distribution pattern of microbiota in cervical intraepithelial neoplasia (CIN) lesions obtained from HIS (n = 12), AA (n = 12), and CA (n = 12) women, who were screened for CC risk assessment. We employed a 16S rRNA gene sequencing approach adapted from the NIH-Human Microbiome Project to identify the microbial niche in all CIN lesions (n = 36).Results: We detected an appreciably decreased abundance of beneficial Lactobacillus in the CIN lesions of the AA and HIS women compared to the CA women. Differential abundance of potentially pathogenic Prevotella, Delftia, Gardnerella, and Fastidiosipila was also evident among the various racial groups. An increased abundance of Micrococcus was also evident in AA and HIS women compared to the CA women. The detection level of Rhizobium was higher among the AA ad CA women compared to the HIS women. In addition to the top 10 microbes, a unique niche of 27 microbes was identified exclusively in women with a histopathological diagnosis of CIN. Among these microbes, a group of 8 microbiota; Rubellimicrobium, Podobacter, Brevibacterium, Paracoccus, Atopobium, Brevundimonous, Comamonous, and Novospingobium was detected only in the CIN lesions obtained from AA and CA women.Conclusions: Microbial dysbiosis in the cervical epithelium represented by an increased ratio of potentially pathogenic to beneficial microbes may be associated with increased CC risk disparities. Developing a race-specific reliable panel of microbial markers could be beneficial for CC risk assessment, disease prevention, and/or therapeutic guidance. [ABSTRACT FROM AUTHOR]

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

It is important to develop effective therapies in minorities to ensure equity in cancer care. Underrepresentation of minorities in early phase trials may cause therapies that are effective only in majority populations. We evaluated minority participation in gynecologic oncology phase 1 clinical trials. In peer-reviewed published articles of gynecologic oncology phase 1 clinical trials from years 1985 to 2018, we manually abstracted racial distribution of enrolled participants, cancer type, and year published. We calculated expected and observed ratios of racial participation on the basis of age-adjusted cancer incidence for race from the United States Centers for Disease Control and Prevention. We identified 357 articles of phase 1 trials (total, 9492 participants), including 213 articles on ovarian cancer (60%). Racial distribution of participants was available in 84 articles (23%) that included 2483 participants (26%): 1950 white (79%), 140 black (5%), and 393 other participants (16%). Other nonwhite races exceeded black enrollment in 46 of 84 trials (55%) that listed race. Enrollment of black participants was less than expected from disease incidence for ovarian (incidence-to-enrollment ratio, 18.5; P <.001), endometrial (3.6; P <.001), and cervical cancer (6.8; P <.001). No phase 1 study met expected enrollment for black participants. Frequency of black participants decreased 1.8-fold from 1995 to 1999 (8 of 70 participants [11%]) to 2015–2018 (55 of 892 participants [6%]; P <.025). Major racial underrepresentation exists in gynecologic oncology phase 1 clinical trials. Enrollment of more black participants is needed to achieve racial equity. • In gynecologic oncology phase 1 trials, enrollment of black participants was less than expected from disease incidence. • Race information was available only in 83 of 357 articles (23%). • Frequency of black participants decreased 1.9-fold from 1995 to 1999 (11%) to 2015–2018 (6%). [ABSTRACT FROM AUTHOR]

Cervical cancer is a preventable disease. HPV infection has been linked to more than 90% of cervical cancers. A vaccine to prevent the acquisition of HPV has been available since 2006. The purpose of this study was to investigate women's perceptions of cervical cancer prevention, including HPV vaccination. A reproductive justice framework guided data collection and analysis. In 2016, researchers conducted 70 in-depth, semi-structured qualitative interviews with women aged 19–78 years in South Carolina. A purposive sampling approach was employed to maximize requisite variety based on social, economic, and environmental axes of inequality. Participants self-identified as white (53%), African American (33%), and Hispanic (9%). Data analysis included an inductive constant comparative method to identify patterns and themes across the interviews. Misinformation about the prevalence and risk of HPV and cervical cancer led to "othering" of women with HPV-related diagnoses based on the flawed assumption of not being at risk. Participants described a lack of knowledge about the effectiveness and safety of the HPV vaccine. Social norms influenced participants' perceptions of HPV vaccination and cervical cancer, including concerns about sexual activity and intergenerational communication. Participants' social construction of identity, including race/ethnicity, socioeconomic position, ability, age, gender, sexual orientation, and immigration status, impacted their perceptions of cervical cancer screening and the HPV vaccine. In particular, participants believed that the HPV vaccine was "only for girls" and identified gender norms that limited uptake. Participants described barriers to accessing health care and cervical cancer screening, including cost, health insurance, and life changes (e.g., pregnancy, relocating). Many participants experienced an abnormal Papanicolaou test and described follow-up care, including biopsies and treatment for cervical dysplasia. Findings from this study offer insight into women's identity and perceptions of cervical cancer prevention. Results provide practical recommendations to increase women's agency in the development of successful public health interventions. • Misinformation about the prevalence and risk of HPV and cervical cancer was common. • Medicalization, including the frequency of abnormal Pap tests, disempowered women. • Social norms influenced concerns about sexual activity and stigma. • Participants' identity impacted perceptions of cervical cancer prevention. [ABSTRACT FROM AUTHOR]

Objectives: Treatment of gynecologic cancers can lead to significant financial and productivity burdens, causing long-term detriments to patients even after their treatment is complete. This is particularly true in states without Medicaid expansion and with high rates of disease. We use a validated tool to understand financial toxicity in gynecologic oncology patients undergoing treatment in the Deep South, where rurality, poverty, and racial disparities disproportionately affect a much higher percentage of the population. Methods: Patients undergoing active treatment for gynecologic cancers were asked to complete a survey about cancer-related costs. The Comprehensive Score for Financial Toxicity (COST) tool was used with <26 indicating moderate and <14 indicating severe financial toxicity. The COST scores for groups based on demographic and clinical data obtained from the medical record were compared as well as the relationship of COST score was compared to reported opportunity costs. Statistical analyses were done using t-test, Fischer's Exact, and Wilcoxon rank-sign tests. Results: Forty-six patients were approached to complete the survey. Of these, 40 patients filled out the survey completely and had clinical data available. The mean age was 59 years (range: 28-89). Among the participants, 67% were White, and 33% were Black; 52.5% had an annual household income of less than $40,000. Twenty-seven patients (67.5%) had public insurance, and ten (25.0%) had private. Patients were being treated for ovarian (27.5%), uterine (30.0%), cervical (32.5%), or vulvar/vaginal cancers (12.5%). Patients were receiving chemotherapy (90%), radiation (35.0%) and/or immunotherapy (17.5%). Five patients (12.5%) were on a clinical trial. Twenty-eight patients (70%) experienced financial toxicity, with ten (25%) experiencing severe toxicity. Age, race, education level, and insurance status were not significantly different between patients who had financial toxicity versus those who did not, though there was a trend toward higher education level and private insurance with the absence of financial toxicity. Income was associated with moderate and severe financial toxicity (p=0.02). Financial toxicity did not differ for patients based on cancer type, treatment type, or the time spent on travel or in a clinic. The severity of the patients' perceived financial burden directly correlated with the COST score (p<0.01). Lower COST scores were associated with a higher likelihood of unemployment or disability due to treatment (p<0.01). Lower COST scores were also associated with a higher likelihood of having to borrow money (p<0.01), using their savings for medical expenses (p<0.01), and being unable to pay for basic necessities (p<0.01). In addition, family members of patients with lower COST scores were more likely to start working more (p<0.01) (Figure 1). Conclusions: Our patients in the Deep South experience financial toxicity at almost double the rate of previous reports. Financial toxicity has been associated with poor outcomes, bankruptcy, generational poverty, and widening disparities experienced by these patients. More research is needed on financial toxicity to improve cancer care equity, particularly as newer and more expensive agents become the standard of care. [ABSTRACT FROM AUTHOR]

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

RGS10 regulates ovarian cancer cell growth and survival, and RGS10 expression is suppressed in cell models of ovarian cancer chemoresistance. However, the mechanisms governing RGS10 expression in ovarian cancer are poorly understood. Here we report RGS10 suppression in primary ovarian cancer and CAOV-3 ovarian cancer cells compared to immortalized ovarian surface epithelial (IOSE) cells, and in A2780-AD chemoresistant cells compared to parental A2780 cells. RGS10-1 and RGS10-2 transcripts are expressed in ovarian cancer cells, but only RGS10-1 is suppressed in A2780-AD and CAOV-3 cells, and the RGS10-1 promoter is uniquely enriched in CpG dinucleotides. Pharmacological inhibition of DNA methyl-transferases (DNMTs) increased RGS10 expression, suggesting potential regulation by DNA methylation. Bisulfite sequencing analysis identified a region of the RGS10-1 promoter with significantly enhanced DNA methylation in chemoresistant A2780-AD cells relative to parental A2780 cells. DNA methylation in CAOV-3 and IOSE cells was similar to A2780 cells. More marked differences were observed in histone acetylation of the RGS10-1 promoter. Acetylated histone H3 associated with the RGS10-1 promoter was significantly lower in A2780-AD cells compared to parental cells, with a corresponding increase in histone deacetylase (HDAC) enzyme association. Similarly, acetylated histone levels at the RGS10-1 promoter were markedly lower in CAOV-3 cells compared to IOSE cells, and HDAC1 binding was doubled in CAOV-3 cells. Finally, we show that pharmacological inhibition of DNMT or HDAC enzymes in chemoresistant A2780-AD cells increases RGS10 expression and enhances cisplatin toxicity. These data suggest that histone de-acetylation and DNA methylation correlate with RGS10 suppression and chemoresistance in ovarian cancer. Markers for loss of RGS10 expression may identify cancer cells with unique response to therapeutics. [ABSTRACT FROM AUTHOR]

Molecular tumor profiling has become increasingly utilized in gynecologic cancers in order to guide treatment management and predict prognosis. Prior data demonstrates that insurance status or race can impact a patient's ability to access molecular tumor profiling. We aim to examine factors that correlate with patients undergoing molecular tumor profiling in order to identify patients that are not receiving tumor profiling who could potentially benefit. A retrospective cohort study was performed on uterine cancer patients diagnosed and treated at a large academic institute in the deep south between 2012 and 2018 with adequate follow up. Molecular profiling was performed via IHC and a 592 gene NextGen Sequencing platform. Clinicopathologic data was abstracted and used for comparative analyses. Of 1013 uterine cancer patients that were identified, 11.1% (n=112) had molecular profiling performed. Black women were significantly more likely to have molecular testing than White women (19.4% vs 8.12%, p<0.001). Type of insurance did not alter use of molecular testing with Private insurance (8.9%), Medicare (12.5%), Medicaid (5.3%), and Self Pay (10.8%) statistically similar (p=0.23). With regards to pathology, increasing grade correlated with increased molecular testing (p<0.001), as did high risk vs low risk histology (28% vs 5%, p<0.001). Thirty of the 33 (90.9) grade 1 tumors were tested at the time of recurrence. Increasing stage also correlated with an increase in molecular testing (stage 1-4: 4.7%, 19.2%, 48.4%, and 48.2% respectively, p<0.001). Of patients that had molecular testing, 80% received adjuvant therapy and 67.0% had recurrent disease (p<0.001). Utilization of molecular profiling in uterine cancers was performed in appropriate clinical scenarios of those who required adjuvant therapy or recurrence. Previously reported obstacles to molecular profiling were not seen in our dataset as payer status or race did not negatively affect appropriate use. [ABSTRACT FROM AUTHOR]

Major racial underrepresentation onto gynecologic oncology clinical trials has been a systemic impediment towards racial equity in care. Previous work demonstrated a 9.8-fold lower enrollment of black patients onto national Gynecologic Oncology Group (GOG) trials compared to whites. In the Deep South, multiple barriers exist that further exacerbate this disparity. Our objective was to investigate clinical trial enrollment at our institution after the implementation of patient-based programs designed specifically to enhance minority enrollment in clinical trials. An intentional multifaceted intervention was created to address Black patient enrollment onto clinical trials. A lay navigation program was established at our cancer center in conjunction with oncology care models focused on improving quality of care by layering proper education of our patients on the risks and benefits of clinical trials in cancer. A diverse lay navigation workforce was hired that mirrored the demographics of our catchment area. We performed a retrospective cohort study of all endometrial cancer patients diagnosed and treated at our institution between 2012 and 2018. Expected and observed white: black ratios of racial participation in clinical trials were calculated utilizing CDC age-adjusted endometrial cancer incidence for race. A total of 1,021 patients with endometrial cancer had adequate follow-up for evaluation of this study. Per our institutional goals for oncology care models, each new endometrial cancer patient was assigned a lay navigator with clinical trial education module required for all patients. Over the study period, 84 patients were enrolled onto clinical trials. Patients were similar in age, BMI, race, morbidity, stage and tumor histology. A total of 23 out of 277 black women (8.3%) and 61 of 718 white women (8.5%) with endometrial cancer participated in clinical trials. Accounting for age-adjusted incidence of endometrial cancer in the United States, observed enrollment of Black women was statistically similar to expected enrollment (1.03 fold lower than the expected p=0.77). Using regional "Deep South" data, we observed a 1.15 fold higher enrollment compared to expected enrollment for black patients (p=0.54). For the entire cohort, a progression-free survival (PFS) disadvantage was demonstrated for black patients compared to whites (14 vs 20 months, respectively p=0.02). Stratifying by clinical trial enrollment, PFS equity was achieved for black patients compared to white patients (13 vs 14 months, p=0.28) (Figure 1). [Display omitted] Clinical trial inequities can be overcome in the Deep South with specific interventions aimed at improving care for black women. Particularly encouraging are the equal progression free survival data for those enrolled onto clinical trials regardless of race. [ABSTRACT FROM AUTHOR]