What's in it for me?: A value assessment of gynecologic cancer clinical trials for Black women.

OBJECTIVE: Underrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals. METHODS: ClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations. RESULTS: 279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001-2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration. CONCLUSIONS: Gynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.

Setting a research agenda for vascular Ehlers-Danlos syndrome using a patient and stakeholder engagement model.

OBJECTIVE: Vascular Ehlers-Danlos syndrome (vEDS) is a rare, syndromic, heritable condition with life-threatening complications that include aortic and arterial aneurysms, dissection, and rupture. This study describes the formation of the vEDS Research Collaborative and methods used for stakeholder engagement. METHODS: The vEDS Research Collaborative was established with an engagement award from the Patient-Centered Outcomes Research Institute to create a framework for a patient-researcher partnership. Between October 1, 2017, and September 30, 2018, the Collaborative used the Patient-Centered Outcomes Research Institute Engagement Rubric to conduct stakeholder engagement to develop a patient-centered research agenda. A modified Delphi technique was used to develop and to refine research topics and questions, gathering input from all stakeholders during three rounds of feedback. RESULTS: Four topic areas were deemed important: mental health and quality of life issues, creating a care team, a holistic approach to vEDS management (medical and surgical), and pregnancy management. An online survey to rank a list of 12 research questions in these topic areas in order of importance was disseminated. The questions were ranked in order of importance through an online survey (N = 197 responses). The survey showed a high degree of alignment in the top priorities among stakeholders. There was a high degree of interest in pragmatic clinical trials evaluating medical management options and health-related quality of life outcomes. CONCLUSIONS: The vEDS Research Collaborative has built a sustainable, coalition model of patient and stakeholder engagement, supported by the vEDS community, to identify a patient-centered, prioritized list of research questions. In articulating a shared vision for the future of vEDS research, the Collaborative has laid the groundwork for developing research protocols aligned with the highest priority questions for the individuals affected by this serious condition that can be translated into future clinical trials.

Assessment of the Information Sources and Interest in Research Collaboration Among Individuals with Vascular Ehlers-Danlos Syndrome.

BACKGROUND: Patient-centered research requires active engagement of patients. The vascular Ehlers-Danlos Syndrome (vEDS) research collaborative was established to ascertain patient-centered vEDS research priorities and to engage affected individuals as research partners. Evaluation of access to information and interest in research among individuals with vEDS was the first step undertaken as part of this work. METHODS: A 28-question survey was created to evaluate 4 domains of interest: diagnostic and clinical care history, vEDS experience, information resources, and willingness to collaborate with researchers. The survey was created in REDCap™ and disseminated between January and April 2018 via the vEDS social media pages, blogs, and advocacy Web sites. Results were collated and described. A single open-ended question yielded additional narrative data, which were analyzed qualitatively. RESULTS: Of the 300 responses, 228 (76%) were completed on behalf of oneself. The vEDS diagnosis was confirmed by genetic testing for 85% of respondents. When asked "Did a physician explain vEDS to you and how to manage it?" 25% answered no. Most had a primary care provider (65%), cardiologist (56%), and vascular surgeon (52%). Only 32% had a local vascular surgeon. The most commonly reported frustration was no cure/treatment available and the emergency rooms do not know what VEDS is (64.5% and 61.8%, respectively). The Internet was the most useful information source (62.3%) followed by a geneticist (18.4%). Most (87.7%) are willing to share their medical records for research studies (87.7%) and wished to be contacted about future studies (83.8%); however, only 65.4% would be willing to upload medical records via a secure confidential Web application. The most common reason for interest in research partnership was to advance research for a treatment/cure (83.8%) and helping others learn from their experiences (82.9%). The qualitative analysis provided additional insights into the patient experience living with vEDS. CONCLUSIONS: Among individuals with vEDS, there is substantial frustration with the lack of treatment, lack of knowledge among health care providers, and a high degree of interest in research involvement. The survey highlights an opportunity to discuss the optimal modality for research participation and methodologies for building trust in the research teams. The methodology lessons learned can also be applied to other rare vascular diseases.

Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial.

Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. Patients & methods: This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. Data analysis: Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. Discussion/conclusion: Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC. Clinical Trial Registration: NCT04930159 (ClinicalTrials.gov).

Endometrial Cancer Knowledge and Guideline-Concordant Practice Patterns Among First-Line Providers.

Background: Provider uncertainty about the appropriate guideline-concordant evaluation of endometrial cancer (EC) symptoms may be a factor in racial inequities in EC. To evaluate the relationship between EC knowledge and reported practice patterns in a nationally representative survey of first-line providers for initial EC symptoms. Materials and Methods: This was a mailed cross-sectional survey of physicians and nurse practitioners from professional organization roster of providers from Obstetrics and Gynecology (OBGYN), Family Medicine, Internal Medicine, and Emergency Medicine. It queried demographics, practice characteristics, EC knowledge, and guideline-concordant practice patterns via three case vignettes. Regions of low response were retargeted to ensure strong representation among providers caring for Black women patients. EC knowledge was analyzed via a composite score (range: -3 to 10, with higher scores representing more EC knowledge), and adjusted prevalence ratios (PRs) used to test the association between knowledge and reported practice patterns. Results: Among 531 returned surveys (response rate = 38%), OBGYN had highest (53%) frequency of >6 (median) EC knowledge score, and Emergency Medicine had the lowest (15%) (p < 0.001). Nonguideline-concordant practice patterns were reported in 14%, 41%, and 35% of the three EC cases presented. Providers with knowledge >6, (n = 205) were significantly more likely to report guideline-concordant care on case vignettes (PR 1.28-1.36). Conclusions: In a national survey of multi-specialty backgrounds, there were basic knowledge gaps about EC and EC risk factors among providers, and a sizeable proportion reported nonguideline concordant practices. These findings indicate the importance of targeted education and training for first-line providers, as EC incidence rises.

"We Are a Powerful Movement": Evaluation of an Endometrial Cancer Education Program for Black Women.

BACKGROUND: U.S. Black women with endometrial cancer (EC) have a 90% higher mortality rate than White women, driven in part by advanced stage at diagnosis. Black women have expressed reasons for care-seeking delay: misattribution of postmenopausal bleeding, symptom endurance, and community silence regarding vaginal bleeding. OBJECTIVES: In this community-based participatory research study, we adapted, implemented, and evaluated an education program addressing these factors. METHODS: We adapted an evidenced-based education curriculum-Community Empowerment Partners (CEPs©)-using Public Health Critical Race Praxis and the Health Belief Model. Black EC survivors completed CEPs-EC training and committed to lead community sessions. Our mixed-methods evaluation measured baseline and follow-up knowledge (10-point scale) and social and clinical empowerment (three Likert-scaled items) and assessed change in each construct with linear mixed-effects models and Generalized Estimating Equation models, respectively. The process evaluation examined fidelity, feasibility, and acceptability using qualitative data from coaching and national peer educator calls, with directed content analysis. RESULTS: Thirteen ambassadors completed training; 10 completed community sessions with 109 total attendees, 62 with complete data. Among community participants, CEPs-EC participation was associated with increased knowledge of 2.02 points (95% confidence interval [CI], 1.06-2.99; p = 0.0001). Social empowerment increased (odds ratio, 8.85; 95% CI, 1.90-41.20), reinforced by qualitative data. There was no change in clinical empowerment. Process data illustrated facilitators of success: session tailoring, leveraging social networks, mentorship, and group-level motivation. CONCLUSIONS: This is the first intervention addressing EC survival among Black women. Results demonstrate efficacy in improving EC knowledge and empowerment, providing the evidence base for a larger public health campaign.

Assessment of Prediagnostic Experiences of Black Women With Endometrial Cancer in the United States.

Importance: Black women with endometrial cancer have a 90% higher mortality rate than white women with endometrial cancer. The advanced disease stage at which black women receive a diagnosis of endometrial cancer is a major factor in this disparity and is not explained by differences in health care access. Objective: To describe the prediagnostic experiences of symptoms and symptom disclosure among black women with endometrial cancer. Design, Setting, and Participants: This community-engaged qualitative study developed an interview guide to collect data during semistructured interviews among a sample of 15 black women with endometrial cancer in the United States. Interviews were conducted in person or via a secure conferencing platform. An exploratory and descriptive content analysis was performed using iterative rounds of inductive coding, case summaries, and coanalysis with community input to identify emergent themes. Data were collected from October 3, 2017, to April 15, 2019, and the descriptive content analysis was performed from October 11, 2017, to May 6, 2019. Main Outcomes and Measures: Beliefs, interpretations, and experiences of black women with endometrial cancer from symptom onset to diagnostic confirmation of cancer. Results: Participants included 15 women who self-identified as black or African American and ranged in age from 31 to 72 years. Eight participants lived in the Puget Sound region of Washington, 2 participants lived in California, and 1 participant each lived in Alabama, Michigan, Louisiana, Georgia, and New York. Twelve participants were receiving adjuvant therapy during the study, which indicated that they were either in a high-risk group and/or had advanced-stage disease. Thirteen participants had health insurance at the time of symptom onset, and all participants had elected to receive cancer treatment. Participants described knowledge gaps and silence about menopause, misinterpretation of vaginal bleeding, and responses by first-line health care practitioners that were not aligned with the risk of endometrial cancer among black women in the United States. Conclusions and Relevance: The responses of interviewed black women with endometrial cancer suggest that several mechanisms may be associated with a delay in care before diagnosis among this high-risk population and represent modifiable factors that may be useful in the development of targeted interventions to improve the rates of early diagnosis among black women with endometrial cancer.