Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices.

BACKGROUND: Germline genetic testing is recommended by the National Comprehensive Cancer Network (NCCN) for individuals including, but not limited to, those with a personal history of ovarian cancer, young-onset (< 50 years) breast cancer, and a family history of ovarian cancer or male breast cancer. Genetic testing is underused overall, and rates are consistently lower among Black and Hispanic populations. Behavioral economics-informed implementation strategies, or nudges, directed towards patients and clinicians may increase the use of this evidence-based clinical practice. METHODS: Patients meeting eligibility for germline genetic testing for breast and ovarian cancer will be identified using electronic phenotyping algorithms. A pragmatic cohort study will test three sequential strategies to promote genetic testing, two directed at patients and one directed at clinicians, deployed in the electronic health record (EHR) for patients in OB-GYN clinics across a diverse academic medical center. We will use rapid cycle approaches informed by relevant clinician and patient experiences, health equity, and behavioral economics to optimize and de-risk our strategies and methods before trial initiation. Step 1 will send patients messages through the health system patient portal. For non-responders, step 2 will reach out to patients via text message. For non-responders, Step 3 will contact patients' clinicians using a novel "pend and send" tool in the EHR. The primary implementation outcome is engagement with germline genetic testing for breast and ovarian cancer predisposition, defined as a scheduled genetic counseling appointment. Patient data collected through the EHR (e.g., race/ethnicity, geocoded address) will be examined as moderators of the impact of the strategies. DISCUSSION: This study will be one of the first to sequentially examine the effects of patient- and clinician-directed strategies informed by behavioral economics on engagement with breast and ovarian cancer genetic testing. The pragmatic and sequential design will facilitate a large and diverse patient sample, allow for the assessment of incremental gains from different implementation strategies, and permit the assessment of moderators of strategy effectiveness. The findings may help determine the impact of low-cost, highly transportable implementation strategies that can be integrated into healthcare systems to improve the use of genomic medicine. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05721326. Registered February 10, 2023. https://www. CLINICALTRIALS: gov/study/NCT05721326.

Association of Oncologist Participation in Medicare's Oncology Care Model With Patient Receipt of Novel Cancer Therapies.

Importance: Medicare's Oncology Care Model (OCM) was an alternative payment model that tied performance-based payments to cost and quality goals for participating oncology practices. A major concern about the OCM regarded inclusion of high-cost cancer therapies, which could potentially disincentivize oncologists from prescribing novel therapies. Objective: To examine whether oncologist participation in the OCM changed the likelihood that patients received novel therapies vs alternative treatments. Design, Setting, and Participants: This cohort study of Surveillance, Epidemiology, and End Results (SEER) Program data and Medicare claims compared patient receipt of novel therapies for patients treated by oncologists participating vs not participating in the OCM in the period before (January 2015-June 2016) and after (July 2016-December 2018) OCM initiation. Participants included Medicare fee-for-service beneficiaries in SEER registries who were eligible to receive 1 of 10 novel cancer therapies that received US Food and Drug Administration approval in the 18 months before implementation of the OCM. The study excluded the Hawaii registry because complete data were not available at the time of the data request. Patients in the OCM vs non-OCM groups were matched on novel therapy cohort, outcome time period, and oncologist specialist status. Analysis was conducted between July 2021 and April 2022. Exposures: Oncologist participation in the OCM. Main Outcomes and Measures: Preplanned analyses evaluated patient receipt of 1 of 10 novel therapies vs alternative therapies specific to the patient's cancer for the overall study sample and for racial subgroups. Results: The study included 2839 matched patients (760 in the OCM group and 2079 in the non-OCM group; median [IQR] age, 72.7 [68.3-77.6] years; 1591 women [56.0%]). Among patients in the non-OCM group, 33.2% received novel therapies before and 40.1% received novel therapies after the start of the OCM vs 39.9% and 50.3% of patients in the OCM group (adjusted difference-in-differences, 3.5 percentage points; 95% CI, -3.7 to 10.7 percentage points; P = .34). In subgroup analyses, second-line immunotherapy use in lung cancer was greater among patients in the OCM group vs non-OCM group (adjusted difference-in-differences, 17.4 percentage points; 95% CI, 4.8-30.0 percentage points; P = .007), but no differences were seen in other subgroups. Over the entire study period, patients with oncologists participating in the OCM were more likely to receive novel therapies than those with oncologists who were not participating (odds ratio, 1.47; 95% CI, 1.09-1.97; P = .01). Conclusions and Relevance: This study found that participation in the OCM was not associated with oncologists' prescribing novel therapies to Medicare beneficiaries with cancer. These findings suggest that OCM financial incentives did not decrease patient access to novel therapies.

Best Practices for Reducing Unplanned Acute Care for Patients With Cancer.

Variation and cost in oncology care represent a large and growing burden for the US health care system, and acute hospital care is one of the single largest drivers. Reduction of unplanned acute care is a major priority for clinical transformation in oncology; proposed changes to Medicare reimbursement for patients with cancer who suffer unplanned admissions while receiving chemotherapy heighten the need. We conducted a review of best practices to reduce unplanned acute care for patients with cancer. We searched PubMed for articles published between 2000 and 2017 and reviewed guidelines published by professional organizations. We identified five strategies to reduce unplanned acute care for patients with cancer: (1) identify patients at high risk for unplanned acute care; (2) enhance access and care coordination; (3) standardize clinical pathways for symptom management; (4) develop new loci for urgent cancer care; and (5) use early palliative care. We assessed each strategy on the basis of specific outcomes: reduction in emergency department visits, reduction in hospitalizations, and reduction in rehospitalizations within 30 days. For each, we define gaps in knowledge and identify areas for future effort. These five strategies can be implemented separately or, with possibly more success, as an integrated program to reduce unplanned acute care for patients with cancer. Because of the large investment required and the limited data on effectiveness, there should be further research and evaluation to identify the optimal strategies to reduce emergency department visits, hospitalizations, and rehospitalizations. Proposed reimbursement changes amplify the need for cancer programs to focus on this issue.

Relation Between Narrow Networks and Providers of Cancer Care.

Purpose Health insurers offer plans covering a narrow subset of providers in an attempt to lower premiums and compete for consumers. However, narrow networks may limit access to high-quality providers, particularly those caring for patients with cancer. Methods We examined provider networks offered on the 2014 individual health insurance exchanges, assessing oncologist supply and network participation in areas that do and do not contain one of 69 National Cancer Institute (NCI)-Designated Cancer Centers. We characterized a network's inclusion of oncologists affiliated with NCI-Designated Cancer Centers relative to oncologists excluded from the network within the same region and assessed the relationship between this relative inclusion and each network's breadth. We repeated these analyses among networks offered in the same regions as the subset of 27 NCI-Designated Cancer Centers identified as National Comprehensive Cancer Network (NCCN) Cancer Centers. Results In regions containing NCI-Designated Cancer Centers, there were 13.7 oncologists per 100,000 residents and 4.9 (standard deviation [SD], 2.8) networks covering a mean of 39.4% (SD, 26.2%) of those oncologists, compared with 8.8 oncologists per 100,000 residents and 3.2 (SD, 2.1) networks covering on average 49.9% (SD, 26.8%) of the area's oncologists ( P < .001 for all comparisons). There was a strongly significant correlation ( r = 0.4; P < .001) between a network's breadth and its relative inclusion of oncologists associated with NCI-Designated Cancer Centers; this relationship held when considering only affiliation with NCCN Cancer Centers. Conclusion Narrower provider networks are more likely to exclude oncologists affiliated with NCI-Designated or NCCN Cancer Centers. Health insurers, state regulators, and federal lawmakers should offer ways for consumers to learn whether providers of cancer care with particular affiliations are in or out of narrow provider networks.

Dose-Escalated Irradiation and Overall Survival in Men With Nonmetastatic Prostate Cancer.

IMPORTANCE: In 5 published randomized clinical trials, dose-escalated external-beam radiation therapy (EBRT) for prostate cancer resulted in improved biochemical and local control. However, scarce evidence addresses whether dose escalation improves overall survival. OBJECTIVE: To examine the association between dose-escalated EBRT and overall survival among men with nonmetastatic prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We conducted a retrospective, nonrandomized comparative effectiveness study of dose-escalated vs standard-dose EBRT for prostate cancer diagnosed from 2004 to 2006 using the National Cancer Database (NCDB), which includes data from patients treated at Commission on Cancer-accredited community, academic, and comprehensive cancer facilities. Three cohorts were evaluated: men with low-risk (n = 12,229), intermediate-risk (n = 16,714), or high-risk (n = 13,538) prostate cancer. EXPOSURES: We categorized patients in each risk cohort into 2 treatment groups: standard-dose (from 68.4 Gy to <75.6 Gy) or dose-escalated (≥75.6 Gy to 90 Gy) EBRT (1 Gy = 100 rad). MAIN OUTCOMES AND MEASURES: We compared overall survival between treatment groups in each analytic cohort using Cox proportional hazard models with an inverse probability weighted propensity score (IPW-PS) approach. In secondary analyses, we evaluated dose response for survival. RESULTS: Dose-escalated EBRT was associated with improved survival in the intermediate-risk (IPW-PS adjusted hazard ratio [HR], 0.84; 95% CI, 0.80-0.88; P < .001) and high-risk groups (HR, 0.82; 95% CI, 0.78-0.85; P < .001) but not the low-risk group (HR, 0.98; 95% CI, 0.92-1.05; P = .54). For every incremental increase of about 2 Gy in dose, there was a 7.8% (95% CI, 5.4%-10.2%; P < .001) and 6.3% (95% CI, 3.3%-9.1%; P < .001) reduction in the hazard of death for intermediate- and high-risk patients, respectively. CONCLUSIONS AND RELEVANCE: Dose-escalated EBRT is associated with improved overall survival in men with intermediate- and high-risk prostate cancer but not low-risk prostate cancer. These results add to the evidence questioning aggressive local treatment strategies in men with low-risk prostate cancer but supporting such treatment in men with greater disease severity.

Cancer Treatment in Patients With HIV Infection and Non-AIDS-Defining Cancers: A Survey of US Oncologists.

PURPOSE: HIV-infected individuals with non-AIDS-defining cancers are less likely to receive cancer treatment compared with uninfected individuals. We sought to identify provider-level factors influencing the delivery of oncology care to HIV-infected patients. METHODS: A survey was mailed to 500 randomly selected US medical and radiation oncologists. The primary outcome was delivery of standard treatment, assessed by responses to three specialty-specific management questions. We used the χ(2) test to evaluate associations between delivery of standard treatment, provider demographics, and perceptions of HIV-infected individuals. Multivariable logistic regression identified associations using factor analysis to combine several correlated survey questions. RESULTS: Our response rate was 60%; 69% of respondents felt that available cancer management guidelines were insufficient for the care of HIV-infected patients with cancer; 45% never or rarely discussed their cancer management plan with an HIV specialist; 20% and 15% of providers were not comfortable discussing cancer treatment adverse effects and prognosis with their HIV-infected patients with cancer, respectively; 79% indicated that they would provide standard cancer treatment to HIV-infected patients. In multivariable analysis, physicians comfortable discussing adverse effects and prognosis were more likely to provide standard cancer treatment (adjusted odds ratio, 1.52; 95% CI, 1.12 to 2.07). Physicians with concerns about toxicity and efficacy of treatment were significantly less likely to provide standard cancer treatment (adjusted odds ratio, 0.67; 95% CI, 0.53 to 0.85). CONCLUSION: Provider-level factors are associated with delivery of nonstandard cancer treatment to HIV-infected patients. Policy change, provider education, and multidisciplinary collaboration are needed to improve access to cancer treatment.

Risk of second cancers according to radiation therapy technique and modality in prostate cancer survivors.

PURPOSE: Radiation therapy (RT) techniques for prostate cancer are evolving rapidly, but the impact of these changes on risk of second cancers, which are an uncommon but serious consequence of RT, are uncertain. We conducted a comprehensive assessment of risks of second cancer according to RT technique (>10 MV vs ≤10 MV and 3-dimensional [3D] vs 2D RT) and modality (external beam RT, brachytherapy, and combined modes) in a large cohort of prostate cancer patients. METHODS AND MATERIALS: The cohort was constructed using the Surveillance Epidemiology and End Results-Medicare database. We included cases of prostate cancer diagnosed in patients 66 to 84 years of age from 1992 to 2004 and followed through 2009. We used Poisson regression analysis to compare rates of second cancer across RT groups with adjustment for age, follow-up, chemotherapy, hormone therapy, and comorbidities. Analyses of second solid cancers were based on the number of 5-year survivors (n=38,733), and analyses of leukemia were based on number of 2-year survivors (n=52,515) to account for the minimum latency period for radiation-related cancer. RESULTS: During an average of 4.4 years' follow-up among 5-year prostate cancer survivors (2DRT = 5.5 years; 3DRT = 3.9 years; and brachytherapy = 2.7 years), 2933 second solid cancers were diagnosed. There were no significant differences in second solid cancer rates overall between 3DRT and 2DRT patients (relative risk [RR] = 1.00, 95% confidence interval [CI]: 0.91-1.09), but second rectal cancer rates were significantly lower after 3DRT (RR = 0.59, 95% CI: 0.40-0.88). Rates of second solid cancers for higher- and lower-energy RT were similar overall (RR = 0.97, 95% CI: 0.89-1.06), as were rates for site-specific cancers. There were significant reductions in colon cancer and leukemia rates in the first decade after brachytherapy compared to those after external beam RT. CONCLUSIONS: Advanced treatment planning may have reduced rectal cancer risks in prostate cancer survivors by approximately 3 cases per 1000 after 15 years. Despite concerns about the neutron doses, we did not find evidence that higher energy therapy was associated with increased second cancer risks.

Increasing use of dose-escalated external beam radiation therapy for men with nonmetastatic prostate cancer.

PURPOSE: To examine recent practice patterns, using a large national cancer registry, to understand the extent to which dose-escalated external beam radiation therapy (EBRT) has been incorporated into routine clinical practice for men with prostate cancer. METHODS AND MATERIALS: We conducted a retrospective observational cohort study using the National Cancer Data Base, a nationwide oncology outcomes database in the United States. We identified 98,755 men diagnosed with nonmetastatic prostate cancer between 2006 and 2011 who received definitive EBRT and classified patients into National Comprehensive Cancer Network (NCCN) risk groups. We defined dose-escalated EBRT as total prescribed dose of ≥75.6 Gy. Using multivariable logistic regression, we examined the association of patient, clinical, and demographic characteristics with the use of dose-escalated EBRT. RESULTS: Overall, 81.6% of men received dose-escalated EBRT during the study period. The use of dose-escalated EBRT did not vary substantially by NCCN risk group. Use of dose-escalated EBRT increased from 70.7% of patients receiving treatment in 2006 to 89.8% of patients receiving treatment in 2011. On multivariable analysis, year of diagnosis and use of intensity modulated radiation therapy were significantly associated with receipt of dose-escalated EBRT. CONCLUSIONS: Our study results indicate that dose-escalated EBRT has been widely adopted by radiation oncologists treating prostate cancer in the United States. The proportion of patients receiving dose-escalated EBRT increased nearly 20% between 2006 and 2011. We observed high utilization rates of dose-escalated EBRT within all disease risk groups. Adoption of intensity modulated radiation therapy was strongly associated with use of dose-escalated treatment.

The rise and fall of prostate brachytherapy: use of brachytherapy for the treatment of localized prostate cancer in the National Cancer Data Base.

BACKGROUND: Brachytherapy has been shown to be an efficacious and cost-effective treatment among patients with localized prostate cancer. In this study, the authors examined trends in brachytherapy use for localized prostate cancer using a large national cancer registry. METHODS: In the National Cancer Data Base (NCDB), a total of 1,547,941 patients with localized prostate cancer were identified from 1998 through 2010. Excluding patients with lymph node-positive or metastatic disease, the authors examined primary treatment trends focusing on the use of brachytherapy over time. Patients with available data (2004-2009) were stratified by National Comprehensive Cancer Network risk criteria. Controlling for year of diagnosis and demographic, clinical, and pathologic characteristics, multivariate analyses were performed examining the association between patient characteristics and receipt of brachytherapy. RESULTS: In the study cohort, brachytherapy use reached a peak of 16.7% in 2002, and then steadily declined to a low of 8% in 2010. Of the 719,789 patients with available data for risk stratification, 41.1%, 35.3%, and 23.6%, respectively, met low, intermediate, and high National Comprehensive Cancer Network risk criteria. After adjustment, patients of increasing age and those with Medicare insurance were more likely to receive brachytherapy. In contrast, patients with intermediate-risk or high-risk disease, Medicaid insurance, increasing comorbidity count, and increasing year of diagnosis were less likely to receive brachytherapy. CONCLUSIONS: For patients with localized prostate cancer who are treated at National Cancer Data Base institutions, there has been a steady decline in brachytherapy use since 2003. For low-risk patients, the declining use of brachytherapy monotherapy compared with more costly emerging therapies has significant health policy implications.

Effect of practice integration between urologists and radiation oncologists on prostate cancer treatment patterns.

PURPOSE: National attention has focused on whether urology-radiation oncology practice integration, known as integrated prostate cancer centers, contributes to the use of intensity modulated radiation therapy, a common and expensive prostate cancer treatment. MATERIALS AND METHODS: We examined prostate cancer treatment patterns before and after conversion of a urology practice to an integrated prostate cancer center in July 2006. Using the SEER (Statistics, Epidemiology and End Results)-Medicare database, we identified patients 65 years old or older in 1 statewide registry diagnosed with nonmetastatic prostate cancer between 2004 and 2007. We classified patients into 3 groups, including 1--those seen by integrated prostate cancer center physicians (exposure group), 2--those living in the same hospital referral region who were not seen by integrated prostate cancer center physicians (hospital referral region control group) and 3--those living elsewhere in the state (state control group). We compared changes in treatment among the 3 groups, adjusting for patient, clinical and socioeconomic factors. RESULTS: Compared with the 8.1 ppt increase in adjusted intensity modulated radiation therapy use in the state control group, the use of this therapy increased 20.3 ppts (95% CI 13.4, 27.1) in the integrated prostate cancer center group and 19.2 ppts (95% CI 9.6, 28.9) in the hospital referral region control group. Androgen deprivation therapy, for which Medicare reimbursement decreased sharply, similarly decreased in integrated prostate cancer center and hospital referral region controls. Prostatectomy decreased significantly in the integrated prostate cancer center group. CONCLUSIONS: Coincident with the conversion of a urology group practice to an integrated prostate cancer center, we observed an increase in intensity modulated radiation therapy and a decrease in androgen deprivation therapy in patients seen by integrated prostate cancer center physicians and those seen in the surrounding health care market that were not observed in the remainder of the state.