Patient care and access to clinical trials in gynaecological oncology: global implications of the early phase of the COVID-19 pandemic.

PURPOSE: Our prospective international survey evaluated the impact of the early phase of the COVID-19 pandemic on the management gynaecological malignancies from the multidisciplinary physicians' perspective with particular focus on clinical infrastructures and trial participation. METHODS: Our survey consisted of 53 COVID-related questions. It was sent to healthcare professionals in gynaecological oncology centres across Europe and Pan-Arabian region via the study groups and gynaecological societies from April 2020 to October 2020. All healthcare professionals treating gynaecological cancers were able to participate in our survey. RESULTS: A total of 255 answers were collected from 30 countries. The majority (73%) of participants were gynaecological oncologists from university hospitals (71%) with at least an Intensive Care Unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years (range 0-12 weeks). Most cases that were prioritised for surgical intervention across all gynaecological tumours were early-stage disease (74%), primary situation (61%) and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumour types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. Almost half of the participants stated the pandemic negatively impacted the financial structure and support for clinical trials. Approximately 20% of clinicians did not feel well-informed regarding clinical algorithm for COVID-19 patients throughout the pandemic. Thirty percent stated that they are currently having trouble in providing adequate medical care due to staff shortage. CONCLUSION: Despite well-established guidelines, pandemic clearly affected clinical research and patientcare. Our survey underlines the necessity for building robust emergency algorithms tailored to gynaecological oncology to minimise negative impact in crises and to preserve access to clinical trials.

Unmet financial needs among patients crowdfunding to support gynecologic cancer care.

BACKGROUND: Patients may use crowdfunding to solicit donations, typically from multiple small donors using internet-based means, to offset the financial toxicity of cancer care. OBJECTIVE: To describe crowdfunding campaigns by gynecologic cancer patients and to compare campaign characteristics and needs expressed between patients with cervical, uterine, and ovarian cancer. STUDY DESIGN: We queried the public crowdfunding forum GoFundMe.com for "cervical cancer," "uterine cancer," and "ovarian cancer." The first 200 consecutive posts for each cancer type fundraising within the United States were analyzed. Data on campaign goals and needs expressed were manually extracted. Descriptive statistics and bivariate analyses were performed. RESULTS: Among the 600 fundraising pages, the median campaign goal was $10,000 [IQR $5000-$23,000]. Campaigns raised a median of 28.6% of their goal with only 8.7% of campaigns reaching their goal after a median of 54 days online. On average, ovarian cancer campaigns had higher monetary goals, more donors, and larger donation amounts than cervical cancer campaigns and raised more money than both cervical and uterine cancer campaigns. Campaigns were fundraising to support medical costs (80-85%) followed by lost wages (36-56%) or living expenses (27-41%). Cervical cancer campaigns reported need for non-medical costs more frequently than uterine or ovarian cancer campaigns. States without Medicaid expansions (31% of the national population) were over-represented among cervical cancer and uterine cancer, but not ovarian cancer campaigns. CONCLUSIONS: Crowdfunding pages reveal patients fundraising for out-of-pocket costs in the thousands of dollars and a wide range of unmet financial needs based on cancer type.

A systematic review of ethnic minority participation in randomised controlled trials of systemic therapies for gynecological cancers.

OBJECTIVE: Randomised controlled trials (RCTs) must include ethnic minority patients to produce generalisable findings and ensure health equity as cancer incidence rises globally. This systematic review examines participation of ethnic minorities in RCTs of licensed systemic anti-cancer therapies (SACT) for gynecological cancers, defining the research population and distribution of research sites to identify disparities in participation on the global scale. METHODS: A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Phase II and III RCTs of licensed therapies for gynecological cancers published 01/11/2012-01/11/2022 that reported patient race/ethnicity were included. Extracted data included race/ethnicity and research site location. RCT populations were aggregated and participation of groups compared. Global distribution of research sites was described. RESULTS: 26 RCTs met inclusion criteria of 351 publications included in full-text screening, representing 17,041 patients. 79.8% were "Caucasian", 9.1% "East Asian", 3.7% "Black/African American" and 6.1% "Other, Unknown, Not Reported". "Caucasian" patients participated at higher rates than all other groups. Of 5,478 research sites, 80.1% were located in North America, 13.0% in Europe, 3.4% in East Asia, 1.3% in the Middle East, 1.3% in South America and 0.8% in Australasia. CONCLUSIONS: Ethnic minorities formed smaller proportions of RCT cohorts compared to the general population. The majority of sites were located in North America and Europe, with few in other regions, limiting enrollment of South Asian, South-East Asian and African patients in particular. Efforts to recruit more ethnic minority patients should be made in North America and Europe. More sites in underserved regions would promote equitable access to RCTs and ensure findings are generalisable to diverse groups. This review assessed the global population enrolled in contemporary RCTs for novel therapies now routinely given for gynecological cancers, adding novel understanding of the global distribution of research sites.

Factors influencing the supportive care needs of female patients with genital cancer in South Korea.

Genital cancers are particularly important compared to other cancers because of the psychological impact they have on the individual. This study investigated the complexity in illness and quality of life among female genital cancer patients and determined the effects of these factors on supportive care needs to provide evidential data for the development of nursing intervention strategies to reduce supportive care needs in female genital cancer patients. This cross-sectional study collected data from July 22 to August 17, 2021. The study subjects were 103 female outpatients and inpatients aged 19 years or older who were treated for cervical cancer, endometrial cancer, ovarian cancer, or other female genital cancers such as vulvar cancer and vaginal cancer in a university hospital in Korea. The data were analyzed with t-tests and Scheffé's test using SPSS 26.0. The factors affecting supportive care needs were examined using hierarchical regression. The average age of the subjects was 56.41 (±9.91) years. Cervical cancer was the most common diagnosis at 42.7%, followed by ovarian cancer at 34.0%, and endometrial cancer at 21.4%. The factors affecting supportive care needs included a middle school education or below (ß = 0.21, P = .028), unemployment (ß = 0.23, P = .018), complexity in illness (ß = 0.32, P < .001), and quality of life (ß = -0.68, P < .001). Developing a strategy for managing the complexity in illness and quality of life caused by various variables including disease stage and type of treatment is necessary to reduce the supportive care needs of female genital cancer patients. Improving their quality of life through effective communication with healthcare providers is essential.

An Intervention-Based Approach to Achieve Racial Equity in Gynecologic Oncology.

Racial inequities within gynecologic oncology exist at every step of the cancer continuum. Although the disparities have been well described, there is a significant gap in the literature focused on eliminating inequities in gynecologic cancer outcomes. The goal of this narrative review is to highlight successful, evidence-based interventions from within and outside of gynecologic oncology that alleviate disparity, providing a call to action for further research and implementation efforts within the field. These solutions are organized in the socioecologic framework, where multiple levels of influence-societal, community, organizational, interpersonal, and individual-affect health outcomes.

Long-term impact of the Affordable Care Act's dependent coverage mandate on young women with gynecologic cancer.

BACKGROUND: The dependent coverage mandate in the 2010 Affordable Care Act (ACA) allows young adults to stay on a parent's private insurance through age 26. While this mandate is associated with gains in insurance and early-stage cancer diagnosis, its long-term impact on survival is unknown. OBJECTIVE: To compare insurance coverage, stage at diagnosis, and overall survival in patients with gynecologic cancer before and after the ACA's dependent coverage mandate. METHODS: Using difference-in-differences (DiD) analysis, we conducted a retrospective cohort study comparing outcomes before and after the implementation of the ACA's dependent coverage mandate in young patients with gynecologic cancer, ages 18-26 years (exposure group) to patients ages 27-35 (control group). We analyzed insurance coverage, stage at diagnosis, and 1, 2, and 3-year overall survival, adjusted for age and comorbidities, utilizing the 2004-2017 National Cancer Database. IRB exemption was obtained. RESULTS: A total of 3553 cases pre-reform and 4535 cases post-reform were identified for patients 18-26 years compared to 14,420 pre-reform and 19,821 post-reform for patients age 27-35. The ACA's dependent coverage mandate was associated with significant gains in insurance (DiD 2%, 95% CI 0.6-3.5) and early-stage diagnosis (3.1%, 95% CI 0.6-5.7). The ACA's dependent coverage mandate was associated with significant gains in 3-year survival (2.4%, 95% CI 0.4-4.3) and non-significant gains in 1 and 2-year survival. CONCLUSION: The ACA's dependent coverage mandate is associated with improvements in early-stage diagnosis and survival for young patients with gynecologic cancer. Maintaining insurance gains-and expanding to the remaining uninsured-are critical for the health of young patients with gynecologic cancer.

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.

"I wish I knew about these programs before!" A brief report exploring barriers to financial assistance reported by gynecological oncology patients.

PURPOSE: Despite widespread reports of cancer-related financial hardship, hospital financial assistance programs are underutilized. APPROACH: Rapid qualitative research. SAMPLE: Gynecologic oncology patients with recurrent or metastatic disease, under 65 years old, and Comprehensive Score for Financial Toxicity of 26 or under. METHODS: Semi-structured interviews to elicit (1) financial assistance awareness/knowledge, (2) barriers to accessing assistance, and (3) suggestions for improving access. We analyzed the transcripts using thematic analysis: open coding, consensus building/codebook, and identification of salient themes. FINDINGS: We interviewed 25 patients and identified four barriers and three suggestions for improving access. Barriers: lack of awareness, perceptions of ineligibility, fear of negative consequences, and being overwhelmed. Suggestions: simplifying financial processes, providing individualized assistance, and being more proactive by intervening earlier. CONCLUSION: Increase access by reducing stigma, misconceptions, and more proactively engaging at-risk patients. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Patients may be too afraid or overwhelmed to ask for help. A more proactive, psychosocial approach is needed.

Examining Associations Among Sexual Health, Unmet Care Needs, and Distress in Breast and Gynecologic Cancer Survivors.

OBJECTIVES: This study evaluated breast and gynecologic cancer patients' sexual function, unmet needs related to sexuality, and distress. DATA SOURCES: Secondary analyses of a cross-sectional survey study evaluated measures of sexual function (Female Sexual Function Index [FSFI]), unmet needs (Supportive Care Needs Scale), and distress (Patient Health Questionnaire). χ2 test, t tests, and analysis of variances (ANOVAs) tested bivariate relationships. Subgroup comparisons were made based on the Female Sexual Function Index sexual dysfunction diagnostic cut-off score (<26.55; lower scores indicate greater dysfunction). A regression model tested associations between sexual function and unmet needs with distress as the outcome variable. CONCLUSION: Clinically significant sexual dysfunction was common in this cohort of women. In multivariate modeling, worse sexual function and greater unmet sexuality needs related to greater distress. Future work should explore reasons behind the high levels of sexual dysfunction and unmet needs in female survivors. IMPLICATIONS FOR NURSING PRACTICE: It is important to routinely screen for sexual health concerns among female cancer survivors at all phases of the cancer trajectory including years posttreatment.

Conflicting views during gynecologic cancer care: a comparison of patients' and caregivers' perceptions of burden.

This study describes the experiences of cancer caregivers and compares these experiences with patients' assessment of cancer's toll on their caregiver. Participants (16 patient-caregiver dyads) were recruited from a NCI cancer center of excellence in the northeastern United States. Patients were in treatment for ovarian (n = 7), uterine (n = 2), or endometrial (n = 7) cancers. Caregivers included 7 women and 9 men who described themselves as spouse/partner (n = 7), adult child (n = 4), sister (n = 2), parent (n = 1), nephew (n = 1), and friend (n = 1). Participants completed semi-structured individual interviews that focused on perceptions of caregiver burden or the impact of the patient's diagnosis on the caregiver specifically. Data were coded inductively to identify themes present within participants' responses. This process included open and axial coding. Two overarching themes emerged: (1) patient-caregiver agreement and (2) patient-caregiver disagreement. Patient-caregiver agreement included two subthemes: (1) weight gain and (2) weight loss. Patient-caregiver disagreement consisted of two subthemes: (1) differing perspectives of quantity and quality of caregiving provided and (2) withholding of caregiver concerns. Overall, there was 56% agreement between patient and caregiver responses. The results may inform intervention development to address patient-caregiver communication, cancer caregiver needs, and ultimately improve caregiver quality of life.

Intensity of end-of-life care for gynecologic cancer patients by primary oncologist specialty.

OBJECTIVE: The association of primary oncologist specialty, medical oncology versus gynecologic oncology, on intensity of care at the end of life in elderly patients with gynecologic cancer is unclear. METHODS: This retrospective cohort study used Surveillance, Epidemiology and End Results-Medicare (SEER-M) data. Subjects were fee-for-service Medicare enrollees aged 65 years and older who died of a gynecologic cancer between January 2006 and December 2015. The primary outcome was a composite score for high-intensity care received in the last month of life. Secondary outcomes included invasive procedures and Medicare spending in the last month of life. Simple and multivariable linear and logistic regression analyses evaluated differences in outcomes by primary oncologist specialty. Linear regressions were repeated after creating a more similar control group through nearest-neighbor propensity score matching. RESULTS: Of 12 189 patients, 7705 (63%) had a medical primary oncologist in the last year of life. In adjusted analyses, patients with a gynecologic versus medical primary oncologist received lower rates of high-intensity end-of-life care (53.9% vs 56.6%; p=0.018). Results were similar for the propensity score-matched cohorts. However, having a gynecologic versus medical primary oncologist was associated with higher rates of invasive procedures in the last month of life (43% vs 41%; p=0.014) and higher Medicare spending ($83 859 vs $74 849; p=0.004). CONCLUSIONS: Both specialties engage in overall high levels of intense end-of-life care, with differences by specialty in aspects of aggressive care and spending at the end of life. Physician-level training could be a target for educational or quality improvement initiatives to improve end-of-life cancer care delivery.

Insurance-Mediated Disparities in Gynecologic Oncology Care.

With 102,000 new cases of gynecologic cancer, 30,000 associated deaths annually, and increasing rates of endometrial cancer, gynecologic cancer is a growing problem. Although gynecologic cancer care has advanced significantly in the past decade owing to new therapeutics and specialized training in radical surgery, even insured women face major barriers to accessing and affording quality gynecologic cancer care. This commentary reviews current literature on insurance-mediated disparities in gynecologic cancer and provides education to clinicians on barriers to care. One third of women with a gynecologic cancer never see a gynecologic oncologist. Up to 40% of Medicare Advantage plans lack an in-network gynecologic oncologist, and 33% of private insurance plans do not include an in-network National Cancer Institute-accredited cancer center, limiting access to surgical advances and clinical trials. Women with Medicaid insurance and gynecologic cancer are 25% less likely to receive guideline-concordant care. Among insured women, 50% experience financial toxicity during gynecologic cancer treatment, and costs may be even higher for certain Medicare enrollees. Addressing these insurance-mediated disparities will be important to help our patients fully benefit from the scientific advances in our field and thrive after a gynecologic cancer diagnosis.