Are Patients With Cancer Best Managed in a Clinical Trial?

This Viewpoint analyzes how the NCCN's boxed statement that all cancer is best managed in a clinical trial cannot be applied to all patients and calls for its removal from its clinical practice guidelines.

Predictors of germline genetic testing referral and completion in ovarian cancer patients at a Comprehensive Cancer Center.

OBJECTIVES: To identify predictors of referral and completion of germline genetic testing among newly diagnosed ovarian cancer patients, with a focus on geographic social deprivation, oncologist-level practices, and time between diagnosis and completion of testing. METHODS: Clinical and sociodemographic data were abstracted from medical records of patients newly diagnosed with ovarian cancer between 2014 and 2019 in the University of North Carolina Health System. Factors associated with referral for genetic counseling, completion of germline testing, and time between diagnosis and test results were identified using multivariable regression. RESULTS: 307/459 (67%) patients were referred for genetic counseling and 285/459 (62%) completed testing. The predicted probability of test completion was 0.83 (95% CI: 0.77-0.88) for patients with a referral compared to 0.27 (95% CI: 0.18-0.35) for patients without a referral. The predicted probability of referral was 0.75 (95% CI: 0.69-0.82) for patients at the 25th percentile of ZIP code-level Social Deprivation Index (SDI) and 0.67 (0.60-0.74) for patients at the 75th percentile of SDI. Referral varied by oncologist, with predicted probabilities ranging from 0.47 (95% CI: 0.32-0.62) to 0.93 (95% CI: 0.85-1.00) across oncologists. The median time between diagnosis and test results was 137 days (IQR: 55-248 days). This interval decreased by a predicted 24.46 days per year (95% CI: 37.75-11.16). CONCLUSIONS: We report relatively high germline testing and a promising trend in time from diagnosis to results, with variation by oncologist and patient factors. Automated referral, remote genetic counseling and sample collection, reduced out-of-pocket costs, and educational interventions should be explored.

Physician perspectives on clinician-to-clinician telemedical consultation for gynecologic cancers: A qualitative study.

Objective: Approximately fifteen million women in the United States live > 50 miles from a gynecologic oncologist. Telemedical technology allows patients' local physicians to consult with subspecialist gynecologic oncologists without burdening patients with unnecessary in-person visits. Although critical to adoption of this technology, physicians' input into implementation of clinician-to-clinician consultation has not been sought. We therefore gathered feedback about experiences with referrals, communication, and openness to telemedical consultation from gynecologic oncologists, gynecologists, and medical oncologists. Methods: We recruited gynecologic oncologists, gynecologists, and medical oncologists from practices serving rural patients to participate in semi-structured interviews. The Consolidated Framework for Implementation Research and the Theoretical Domains Framework guided the interviews. Questions focused on factors influencing adoption and implementation of clinician-to-clinician telemedicine. Interviews were conducted via WebEx, recorded, and transcribed. Two investigators coded interviews using the combined frameworks and identified salient themes. Results: We conducted 11 interviews (6 gynecologic oncologists, 3 gynecologists, 2 medical oncologists) and identified themes encompassing communication burnout, barriers to sharing patient information, need for further logistical information, and potential benefits to patients. Conclusions: Clinician-to-clinician telemedicine may improve access to gynecologic cancer care by decreasing barriers to subspecialty expertise while simultaneously benefiting referring and consultant clinicians through improved identification and workup of patients who may need in-person consultation. To optimize desired outcomes, telemedical consultation must allow for communication of relevant patient information and records and easy integration into clinical workflow. Importantly, clinicians must perceive the consultation as improving patients' access to specialty care.

Endometrial cancer survivors' perceptions of their cardiovascular disease risk (results from WF-1804CD AH-HA).

OBJECTIVE: Despite considerable burden of cardiovascular disease (CVD), data on endometrial cancer survivors' CVD perceptions are lacking. We assessed survivors' perspectives on addressing CVD risk during oncology care. METHODS: This cross-sectional analysis utilized data from an ongoing trial of an EHR heart health tool (R01CA226078 & UG1CA189824) conducted through the NCI Community Oncology Research Program (NCORP, WF-1804CD). Endometrial cancer survivors post-potentially curative treatment were recruited from community practices and completed a pre-visit baseline survey, including American Heart Association Simple 7 CVD factors. Likert-type questions assessed confidence in understanding CVD risk, CVD risk perception, and desired discussion during oncology care. Medical record abstraction ascertained data on CVD and cancer characteristics. RESULTS: Survivors (N = 55, median age = 62; 62% 0-2 years post-diagnosis) were predominately white, non-Hispanic (87%). Most agreed/strongly agreed heart disease poses a risk to their health (87%) and oncology providers should talk to patients about heart health (76%). Few survivors reported smoking (12%) but many had poor/intermediate values for blood pressure (95%), body mass index (93%), fasting glucose/A1c (60%), diet (60%), exercise (47%) and total cholesterol (53%). 16% had not seen a PCP in the last year; these survivors were more likely to report financial hardship (22% vs 0%; p = 0.02). Most reported readiness to take steps to maintain or improve heart health (84%). CONCLUSIONS: Discussions of CVD risk during routine oncology care are likely to be well received by endometrial cancer survivors. Strategies are needed to implement CVD risk assessment guidelines and to enhance communication and referrals with primary care. Clinical Trials #: NCT03935282.

An implementation science approach to the systematic study of access to gynecologic cancer care.

INTRODUCTION: Barriers to access to cancer care are profoundly threatening to patients with gynecologic malignancies. Implementation science focuses on empirical investigation of factors influencing delivery of clinical best practices, as well as interventions designed to improve delivery of evidence-based care. We outline one prominent framework for conducting implementation research and discuss its application to improving access to gynecologic cancer care. METHODS: Literature on the use of the Consolidated Framework for Implementation Research (CFIR) was reviewed. Delivery of cytoreductive surgery for advanced ovarian carcinoma was selected as an illustrative case of an evidence-based intervention (EBI) in gynecologic oncology. CFIR domains were applied to the context of cytoreductive surgical care, highlighting examples of empirically-assessable determinants of care delivery. RESULTS: CFIR domains include Innovation, Inner Setting, Outer Setting, Individuals, and Implementation Process. "Innovation" relates to characteristics of the surgical intervention itself; "Inner Setting" relates to the environment in which surgery is delivered. "Outer Setting" refers to the broader care environment influencing the Inner Setting. "Individuals" highlights attributes of persons directly involved in care delivery, and "Implementation Process" focuses on integration of the Innovation within the Inner Setting. CONCLUSIONS: Prioritization of implementation science methods in the study of access to gynecologic cancer care will help ensure that patients are able to utilize interventions with the greatest prospect of benefiting them.

Pre-pandemic geographic access to hospital-based telehealth for cancer care in the United States.

IMPORTANCE: Little is known about US hospitals' capacity to ensure equitable provision of cancer care through telehealth. OBJECTIVE: To conduct a national analysis of hospitals' provision of telehealth and oncologic services prior to the SARS-CoV-2 pandemic, along with geographic and sociodemographic correlates of access. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cross-sectional analysis with Geographic Information Systems mapping of 1) 2019 American Hospital Association (AHA) Annual Hospital Survey and IT Supplement, 2) 2013 Urban Influence Codes (UIC) from the United States Department of Agriculture, 3) 2018 Area Health Resources Files from the Health Services and Resources Administration (HRSA). INTERVENTIONS: Hospitals were categorized by telehealth and oncology services availability. Counties were classified as low-, moderate-, or high-access based on availability of hospital-based oncology and telehealth within their boundaries. MAIN OUTCOMES AND MEASURES: Geospatial mapping of access to hospital-based telehealth for cancer care. Generalized logistic mixed effects models identified associations between sociodemographic factors and county- and hospital-level access to telehealth and oncology care. RESULTS: 2,054 out of 4,540 hospitals (45.2%) reported both telehealth and oncology services. 272 hospitals (6.0%) offered oncology without telehealth, 1,369 (30.2%) offered telehealth without oncology, and 845 (18.6%) hospitals offered neither. 1,288 out of 3,152 counties with 26.6 million residents across 41 states had no hospital-based access to either oncology or telehealth. After adjustment, rural hospitals were less likely than urban hospitals to offer telehealth alongside existing oncology care (OR 0.27; 95% CI 0.14-0.55; p < .001). No county-level factors were significantly associated with telehealth availability among hospitals with oncology. CONCLUSIONS AND RELEVANCE: Hospital-based cancer care and telehealth are widely available across the US; however, 8.4% of patients are at risk for geographic barriers to cancer care. Advocacy for adoption of telehealth is critical to ensuring equitable access to high-quality cancer care, ultimately reducing place-based outcomes disparities. Detailed, prospective, data collection on telehealth utilization for cancer care is also needed to ensure improvement in geographic access inequities.

Routine informed consent for mismatch repair testing in endometrial cancers: Review and ethical analysis.

OBJECTIVE: To review available data regarding consent for tumor testing for mismatch repair (MMR), and to make recommendation for ethical best practices based on synthesis of contemporary data and ethical principles. METHODS: PubMed and CINAHL databases were searched through September 2021; articles reporting on consent for MMR tumor testing for patients at risk for Lynch Syndrome were abstracted. Additional articles were identified through review of references. Key data and ethical principles were extracted, summarized, and analyzed in the context of contemporary clinical practice. RESULTS: 16 articles met inclusion criteria for this review, none of which specifically related to MMR testing for endometrial cancers. All but two studies were published prior to the approval of pembrolizumab for treatment of MMR-deficient tumors. Scant available data suggest that routine consent prior to tumor testing is uncommon; however, several decision aids improved patient knowledge and satisfaction prior to deciding whether to proceed with tumor testing. Previous ethical analyses invoke clinical utility, potential germline implications, and logistical factors in making recommendations regarding consent practices. These analyses varied in their final recommendations; however, all had significant deficits in their arguments related to contemporary clinical care for patients with endometrial cancer. CONCLUSION: Current data are needed to assess the impact of potential consent strategies for tumor testing. Based on available data, and consistent with contemporary ethical best practices, we recommend that planned MMR testing of endometrial cancers be discussed routinely with patients verbally or in surgical consent documents.

A qualitative study of patients' attitudes towards telemedicine for gynecologic cancer care.

INTRODUCTION: Women with gynecologic cancers may face geographic barriers to standard-of-care consultation with a gynecologic oncologist. While telemedicine may help overcome these geographic barriers, there are no qualitative data exploring gynecologic cancer patients' attitudes towards telemedicine for cancer care. Patients with gynecologic malignancies may have preferences distinct from general oncology populations due to the sensitive nature of the diseases and anatomy involved. METHODS: Semi-structured interviews were conducted with 15 patients with gynecologic cancers to identify perceived advantages and disadvantages of telemedicine use for gynecologic cancer care. Past experience with telemedicine was elicited as were suggestions for cancer care encounters most compatible with telemedicine. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: All patients interviewed were open to the use of telemedicine. Emergent themes regarding advantages of telemedicine included convenience, cost savings, reduced travel, avoidance of infectious disease, and availability of care for those too unwell for in-person visits. Themes regarding disadvantages of telemedical care included technical difficulties, perceived need for examination or testing, and potential compromise of therapeutic relationship. Patients were particularly concerned that difficulty in establishing a therapeutic relationship would compromise initial consultations with gynecologic oncologists via telemedicine. CONCLUSION: Patients with gynecologic cancer are open to use of telemedicine for their care. Particular attention should be paid to overcoming patients' hesitancy to have initial visits with gynecologic oncologists, as these consultations have the greatest potential to improve access to high-quality gynecologic cancer care.

Responding to patient requests for women obstetrician-gynecologists.

Patients may request care from a woman obstetrician-gynecologist for various reasons, including privacy concerns, religious or cultural reasons, and in some cases, a history of abuse. They should be given the opportunity to voice their reasons for requesting a woman obstetrician-gynecologist but should not be compelled to do so. Respect for patient autonomy is a compelling reason to consider honoring a patient's gender-based request. When a patient requests a woman obstetrician-gynecologist, efforts should be made to accommodate the request if possible. However, medical professionals and institutions are not ethically obligated to have a woman obstetrician-gynecologist on call or to make one available at all times. If it is not feasible for a woman obstetrician-gynecologist to provide care because of staffing or other system constraints or patient safety concerns, accommodation is not required, and physicians do not have an overriding responsibility to ensure that patients receive gender-concordant care. Patients have the right to decline care and may choose to seek care elsewhere if their requested healthcare provider type is not available. Institutions and medical clinics should have policies and procedures in place for managing patient requests for women obstetrician-gynecologists, and patients should be made aware of these policies preemptively. These policies and procedures should include information about whom to contact for assistance and how to document the encounter. They should also be accessible and familiar to physicians and trainees. Care should be taken to ensure that adequate educational opportunities in obstetrics and gynecology are available for all medical trainees, regardless of gender.

A qualitative study on the impact of long-distance travel for gynecologic cancer care.

BACKGROUND: Women with gynecologic malignancies experience improved clinical outcomes when they are treated by gynecologic oncologists and in high-volume cancer centers. However, geography is a major barrier to high-volume care for patients. This qualitative study was undertaken to identify facilitators and barriers to patients traveling long distances for gynecologic cancer care. METHODS: Semi-structured interviews were conducted with 19 women with gynecologic malignancies traveling >50 miles for treatment at Wake Forest Comprehensive Cancer Center. Eight interviews included caregivers. Four interview domains focused on personal challenges and coping strategies related to accessing cancer care. RESULTS: Mean distance traveled for care was 87 miles (range: 54-218). Most participants reported that recommendations from physicians, friends, and family motivated travel. 10/19 participants were aware of closer sites for cancer care; 5 had unfavorable experiences elsewhere. Barriers to travel included time, cost, childcare, difficulty navigating, and physical discomfort. Social support was an important facilitator of travel for care; some patients utilized loaned money or vehicles. Participants reported significant energy expenditure scheduling travel, coordinating time off work, and arranging overnight stays near the cancer center. Suggestions for care improvement included travel vouchers, transportation assistance, signage and personnel to help with navigation, and appointments later in the day. Participants supported in-person oncologist outreach to rural areas and appointments via telemedicine; few preferred the current infrastructure. CONCLUSION: Patients who travel long distances for gynecologic cancer care encounter significant burdens and rely heavily on social and financial support. Interventions should be developed and evaluated to reduce the burden of long-distance travel and develop efficient methods of outreach, including telemedicine.

State Standards for Insurance Access to Oncologists.

As the market for health insurance plans expands, each state is responsible for setting standards to ensure that plans contain adequate coverage for cancer care. Little is currently known about what criteria states use for network adequacy of insurance plans. We contacted representatives of the Department of Insurance (or equivalent) for 50 states and the District of Columbia, as well as searched official state websites to compile data on network adequacy standards for cancer care nationwide. The standards of 16 (31.4%) states contained only qualitative elements for access to an oncologist (eg, "reasonable access"), 7 (13.7%) states included only quantitative elements (eg, travel distance and time restrictions), and 24 (47.1%) states included standards with both qualitative and quantitative elements. Standards from 4 states were not available. States should make certain that robust, transparent protections exist to ensure that patients are able to access high-quality cancer care without experiencing the financial toxicity associated with out-of-network billing.

Ethical challenges for women's healthcare highlighted by the COVID-19 pandemic.

Healthcare policies developed during the COVID-19 pandemic to safeguard community health have the potential to disadvantage women in three areas. First, protocols for deferral of elective surgery may assign a lower priority to important reproductive outcomes. Second, policies regarding the prevention and treatment of COVID-19 may not capture the complexity of the considerations related to pregnancy. Third, policies formulated to reduce infectious exposure inadvertently may increase disparities in maternal health outcomes and rates of violence towards women. In this commentary, we outline these challenges unique to women's healthcare in a pandemic, provide preliminary recommendations and identify areas for further exploration and refinement of policy.

Telemedicine and Gynecologic Cancer Care.

Patients with gynecologic cancers experience better outcomes when treated by specialists and institutions with experience in their diseases. Unfortunately, high-volume centers tend to be located in densely populated regions, leaving many women with geographic barriers to care. Remote management through telemedicine offers the possibility of decreasing these disparities by extending the reach of specialty expertise and minimizing travel burdens. Telemedicine can assist in diagnosis, treatment planning, preoperative and postoperative follow-up, administration of chemotherapy, provision of palliative care, and surveillance. Telemedical infrastructure requires careful consideration of the needs of relevant stakeholders including patients, caregivers, referring clinicians, specialists, and health system administrators.