INTRODUCTION:Breast cancer chemoprevention is underutilized among high-risk women. We examined whether decision support could increase informed decision-making. METHODS:We conducted a cluster randomized controlled trial to evaluate the effect of a patient-facing decision aid (RealRisks) and provider tool (BNAV) compared to standard education on the number of women with high-risk breast lesions making informed choices. Questionnaires were administered at baseline, 6 and 12 months. The primary outcome was chemoprevention informed choice (defined as adequate knowledge and attitudes congruent with decision) at 6 months. Secondary endpoints included breast cancer risk perceptions, worry, chemoprevention knowledge, decision conflict, and chemoprevention decision. RESULTS:Across 31 randomized sites, we enrolled 210 providers, who were primarily breast health specialists. Twenty-four sites (14 intervention, 10 control) enrolled 412 patients. Among 287 patients evaluable for the primary outcome, there were no significant differences in informed choice between the intervention and control arms at 6 months (35% vs 27%, respectively; p = 0.20) and 12 months (37% vs 25%, respectively; p = 0.05). At 6 months, women in the intervention compared to control arm were more likely to have accurate breast cancer risk perceptions (31% vs 21%, respectively; p = 0.03) and adequate chemoprevention knowledge (33% vs 23%, respectively; p = 0.04). At 12 months, 52% of women in the control and 50% in the intervention arm self-reported initiating chemoprevention. CONCLUSION:Decision support led to modest improvements in accurate risk perceptions and chemoprevention knowledge, but not informed choice. Relatively high chemoprevention uptake was achieved among women with high-risk breast lesions managed mainly by breast health specialists. TRIAL REGISTRATION:NCT04496739.
To determine if the developed Know Your Risk (KYR) intervention is similar to conventional genetic counseling; we evaluated participants’ knowledge of cancer genetics, breast cancer risk perception, attitudes about genetic counseling and testing, and satisfaction with genetic counseling. Women (n = 866) who screened at elevated risk for breast cancer were randomized to the KYR intervention or conventional genetic counseling (2022–2024). The KYR intervention included a series of online pre-test educational videos, direct access to genetic testing, and patient preference for receiving post-test genetic counseling. Participants completed surveys at baseline and after genetic counseling and testing. Non-inferiority hypothesis testing compared the two participant groups. The mean knowledge score (range 0–12) increased in both study groups from a baseline mean of 6.87 (standard deviation (SD) = 2.46) to 8.66 (SD = 2.16) for the KYR intervention and 8.56 (SD = 2.14) for conventional counseling. Additionally, statistical analyses suggest the non-inferiority of the KYR intervention for participants’ accuracy of their breast cancer risk, attitudes about genetic counseling and genetic testing, and satisfaction with genetic counseling compared to participants randomized to conventional genetic counseling. Findings support that the components included in the KYR intervention are non-inferior for cancer genetic knowledge, risk perception, genetic counseling and testing attitudes, and genetic counseling satisfaction among women who screen at elevated risk for breast cancer. By using the combination of components included in the KYR intervention, genetic counseling and genetic testing are more accessible, convenient, and patient-driven. Trial Registration: ClinicalTrials.gov Identifier: NCT05325151.
Background: Application of genomic assays in clinically low-risk hormone receptor positive breast cancer (HR+BC) is understudied as patients with small (T1mi/a/b) node-negative (N0/N1mi) disease were often excluded from prospective trials. However, use of these tests in real world clinical practice, including OncotypeDx, occurs not infrequently, leading clinicians to question the reliability of the results produced whenever they are performed. Methods: We aimed to help address this question by conducting a large, retrospective analysis of available survival data within the National Cancer Database (NCDB) for patients with small, node-negative disease. Where OncotypeDx recurrence score (RS) results were available, we categorized patients into low (RS <11), intermediate (RS 11-25), & high risk (RS 26-100) groupings. Additionally, we categorized patients based receipt of adjuvant chemotherapy. The primary outcome of Overall survival (OS) was explored for patients with high-risk disease via univariate analysis (cox proportional hazard models & Kaplan Meier survival estimates). Secondary outcomes included univariate analysis of OS based on OncotypeDx testing (regardless of chemotherapy receipt or risk group) & OS between low, intermediate, & high-risk patients, independent of chemotherapy use. Results: In total, of the 308513 patients with T1mi/a/b N0/N0(i+)/N1mi HR+BC identified within the NCDB between the years 2010-2020, 18372 (6.0%) had received chemotherapy. Among those chemotherapy recipients who underwent OncotypeDx testing (n=8700), 363 were low risk (4.2%), 3475 were intermediate risk (39.9%), & 4862 were high risk (55.9%). Conversely, 81223 patients with T1mi/a/b N0 HR+BC underwent OncotypeDx testing without receipt of chemotherapy during this period. Of those, 29954 were low risk (36.9%), 48569 were intermediate risk (59.8%), & 2700 were high risk (3.3%). When comparing OS among high-risk patients where chemotherapy was omitted versus administered, a significant reduction in OS was noted with omission (HR 1.73, 95% CI 1.44-2.10, p<0.001), with 5-year OS being 94.9% vs 96.8%, respectively. When comparing OS for patients who underwent OncotypeDx testing versus those who did not, regardless of chemotherapy receipt, there was a significant improvement in OS for those tested (HR 0.45, 95% CI 0.43-0.47, p<0.001), with 5-year OS being 97.2% versus 93.7%, respectively. Furthermore, when comparing OS among low, intermediate, & high-risk patients, regardless of chemotherapy receipt, a significant difference between groups was noted (p<0.001), with high-risk being least favorable. Conclusions: The findings above suggest that risk stratification may be advantageous, even among otherwise clinically low-risk individuals with HR+BC. Multivariable analysis is further planned to better examine the association between OncotypeDx risk categories & pathologic features such as tumor size, nodal findings, tumor grade, estrogen receptor expression levels, progesterone receptor expression levels, & the presence of lymphovascular invasion. Clinical factors, such as age, race, ethnicity, & receipt of endocrine therapy will also be examined. Citation Format: Kai Johnson, Julie A Stephens, Brittany Sandoval, Andrea House, Blair Hoeting, Sachin R Jhawar, Dionisia Quiroga, Gilbert Bader, Ashley P Davenport, Nicole Williams, Mathew A Cherian, Sagar Sardesai, Daniel G Stover, Margaret Gatti-Mays, Samilia Obeng-Gyasi, Bridget A Oppong, Doreen Agnese, Robert Wesolowski. Impact of OncotypeDx Risk Categorization & Receipt of Chemotherapy on Survival Outcomes Among Patients with Small (T1mi/a/b) Node-Negative (N0/N0(i+)/N1mi) Hormone Receptor Positive (HR+) Breast Cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-11-06.
Breast cancer in young adult (YA) women aged 18–39 years old presents distinct challenges. This review synthesizes current evidence on treatment strategies while emphasizing multidisciplinary collaboration. Rising incidence, particularly among Hispanic and Asian-American populations, coupled with aggressive tumor biology and advanced-stage diagnoses contributes to poorer survival outcomes than for those diagnosed at ages ≥40 years old. Diagnostic delays stem from limited screening and dense breast tissue. Treatment decisions, including surgical and systemic therapies, are influenced not only by tumor biology but also by genetic risk, fertility concerns, and psychosocial factors. Advances in targeted therapies and radiation techniques offer promising outcomes but require individualized planning to mitigate long-term toxicity. Despite advancements in the treatment of breast cancer, age-specific guidelines and ongoing research are imperative for improving outcomes and quality of life for YA patients with breast cancer.
INTRODUCTION: Inflammatory breast cancer (IBC) is an aggressive, poor-prognosis subset of breast cancer. Given its rarity and solely clinical criteria for diagnosis, patients with IBC may face delays in diagnosis and appropriate clinical care. IBC patients significantly benefit from a multidisciplinary diagnostic and treatment approach. Therefore, care delivery pathways and concentration at high-volume centers may be advantageous for timely diagnosis and initiation of treatment. Additionally, because IBC is rare, these patients are underrepresented in breast cancer research and clinical trials. We describe the creation of a multidisciplinary IBC Program aimed at expediting intake, standardizing care delivery, improving patient outcomes, and increasing research activities. METHODS: An ad hoc IBC working group of key stakeholders including representatives from surgical oncology, medical oncology, radiation oncology, plastic surgery, radiology, oncology rehabilitation, nursing, patient experience, scheduling, administration, and patient advocates, was formed. A systematic review of high-volume IBC programs was conducted including meeting with the leadership of these IBC programs and reviewing best practices, guidelines, and research operations. An internal assessment was done through retrospective review studies, including internal scheduling processes, timelines to multimodality treatment, and outcomes. RESULTS: Evidence-based clinical practice guidelines for IBC patients were developed and institutionally approved. These included the creation of IBC patient-specific order sets for guideline-concordant testing and procedures as well as creating clinic visit note templates. A new patient scheduling decision tree was created to facilitate expedited scheduling of patients with symptoms suspicious of IBC or an IBC diagnosis. A process improvement cycle was established to review access and timely scheduling of new IBC patients. An IBC education module was created and disseminated to providers across the health system. Our website was updated to include the IBC Program and specific details about IBC, and an IBC patient brochure was created and distributed. As part of this effort, a set of program quality metrics that have been shown to impact patient outcomes was established, and a quality assurance dashboard was built. For example, since launching the IBC Program in 2022, 30 new IBC patients have been seen (previously averaged <5 IBC patients per year) and the average time from receipt of referral to new patient appointment was 5 days. To address research gaps, an IBC research working group was established to offer IBC-specific tissue and blood collection for translational studies. Prior to the dedicated research effort (2008-2021), only 18 IBC patients had enrolled in our breast cancer translational research biorepository with one blood sample per patient. Since the implementation of the IBC Program in 2022, we have enrolled 34 IBC patients and collected 106 blood samples to date. CONCLUSION: Through systematic methods with a multidisciplinary approach, we successfully created and implemented an IBC program at our tertiary-care academic institution. Ongoing efforts involve tracking quality measures, subsequent quality improvement cycles, and expanding IBC-specific research. The program is fulfilling an unmet need of a rare but complex patient population. Citation Format: Heather LeFebvre, Doreen Agnese, Heidi Basinger, Lynne Brophy, Mathew Cherian, Min-Jeong Cho, Tameka Dillard Oneal, Jacob Eckstein, Julia Garrett, Margaret Gatti-Mays, Noel Huber, Sachin R. Jhawar, Kai Johnson, Steven Kalister, Amy Kerger, Nadine Myers, Samila Obeng-Gyasi, Jill Osborn, Ko Un Park, Dionisia Quiroga, Lindsey Radcliff, Kimberly Saxton, Roman Skoracki, Eric Young, Daniel G. Stover. Establishment of an Inflammatory Breast Cancer Program: A Quality Improvement and Research Effort [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P4-04-03.
BACKGROUND:Women with high-risk breast lesions, such as atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), have a 4- to tenfold increased risk of breast cancer compared to women with non-proliferative breast disease. Despite high-quality data supporting chemoprevention, uptake remains low. Interventions are needed to break down barriers. METHODS:The parent trial, MiCHOICE, is a cluster randomized controlled trial evaluating the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. For this pre-implementation analysis, 25 providers participated in semi-structured interviews prior to accessing decision support tools. Interviews sought to understand attitudes/beliefs and barriers/facilitators to chemoprevention. RESULTS:Interviews with 25 providers (18 physicians and 7 advanced practice providers) were included. Providers were predominantly female (84%), white (72%), and non-Hispanic (88%). Nearly all providers (96%) had prescribed chemoprevention for eligible patients. Three themes emerged in qualitative analysis. The first theme describes providers' confidence in chemoprevention and the utility of decision support tools. The second theme elucidates barriers to chemoprevention, including time constraints, risk communication and perceptions of patients' fear of side effects and anxiety. The third theme is the need for early implementation of decision support tools. CONCLUSIONS:This qualitative study suggests that providers were interested in the early inclusion of decision aids (DA) in their chemoprevention discussion workflow. The DAs may help overcome certain barriers which were elucidated in these interviews, including patient level concerns about side effects, clinic time constraints and difficulty communicating risk. A multi-faceted intervention with a DA as one active component may be needed. TRIAL REGISTRATION:This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT04496739.
Individuals with intellectual and developmental disabilities may face barriers in accessing healthcare, including cancer screening and detection services. We sought to assess the association of intellectual and developmental disabilities (IDD) with breast cancer screening rates. Data from 2018 to 2020 was used to identify screening-eligible individuals from Medicare Standard Analytic Files. Adults aged 65–79 years who did not have a previous diagnosis of breast cancer were included. Multivariable regression was used to analyze the differences in breast cancer screening rates among individuals with and without IDD. Among 9,383,349 Medicare beneficiaries, 11,265 (0.1
INTRODUCTION:Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. METHODS/DESIGN:We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. RESULTS/DISCUSSION:With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. CLINICAL SETTINGS: TRIAL REGISTRATION:NCT04496739.
Breast cancer is treated with a multidisciplinary approach involving surgical oncology, radiation oncology, and medical oncology. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer include recommendations for clinical management of patients with carcinoma in situ, invasive breast cancer, Paget's disease, Phyllodes tumor, inflammatory breast cancer, and management of breast cancer during pregnancy. The content featured in this issue focuses on the recommendations for overall management of systemic therapy (preoperative and adjuvant) options for nonmetastatic breast cancer. For the full version of the NCCN Guidelines for Breast Cancer, visit NCCN.org.
Breast cancer is treated with a multidisciplinary approach involving surgical oncology, radiation oncology, and medical oncology. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer include recommendations for clinical management of patients with carcinoma in situ, invasive breast cancer, Paget's disease, Phyllodes tumor, inflammatory breast cancer, and management of breast cancer during pregnancy. The content featured in this issue focuses on the recommendations for overall management of systemic therapy (preoperative and adjuvant) options for nonmetastatic breast cancer. For the full version of the NCCN Guidelines for Breast Cancer, visit NCCN.org.
Rates of contralateral mastectomy (CM) among patients with unilateral breast cancer have been increasing in the United States. In this Society of Surgical Oncology position statement, we review the literature addressing the indications, risks, and benefits of CM since the society's 2017 statement. We held a virtual meeting to outline key topics and then conducted a literature search using PubMed to identify relevant articles. We reviewed the articles and made recommendations based on group consensus. Patients consider CM for many reasons, including concerns regarding the risk of contralateral breast cancer (CBC), desire for improved cosmesis and symmetry, and preferences to avoid ongoing screening, whereas surgeons primarily consider CBC risk when making a recommendation for CM. For patients with a high risk of CBC, CM reduces the risk of new breast cancer, however it is not known to convey an overall survival benefit. Studies evaluating patient satisfaction with CM and reconstruction have yielded mixed results. Imaging with mammography within 12 months before CM is recommended, but routine preoperative breast magnetic resonance imaging is not; there is also no evidence to support routine postmastectomy imaging surveillance. Because the likelihood of identifying an occult malignancy during CM is low, routine sentinel lymph node surgery is not recommended. Data on the rates of postoperative complications are conflicting, and such complications may not be directly related to CM. Adjuvant therapy delays due to complications have not been reported. Surgeons can reduce CM rates by encouraging shared decision making and informed discussions incorporating patient preferences.
Introduction: Oncoplastic breast conservation surgery (BCS) uses concurrent reduction and/ or mastopexy with lumpectomy to improve aesthetic outcomes. However, tissue rear-rangement can shift the original tumor location site in relation to external breast land-marks, resulting in difficulties during re-excision for a positive margin and accurate radiation targeting. We developed the Breast Intraoperative Oncoplastic (BIO) form to help depict the location of the tumor and breast reduction specimen. This study seeks to assess physician perspectives of the implementation outcomes.Methods: From February 2021 to April 2021, the BIO form was used in 11 oncoplastic BCS cases at a single institution. With institutional review board approval, surgical oncologists (SOs), plastic surgeons (PSs), and radiation oncologists (ROs) were administered a 12-question validated survey on Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM), using a 5-point Likert scale during initial implementation and at 6-month reassessment.Results: Twelve physicians completed the survey initially (4 SOs, 4 PSs, and 4 ROs). The mean scores for Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure were high (4.44, 4.56, and 4.56, respec-tively). Twelve completed the second survey (5 SOs, 3 PSs, and 4 ROs). The mean scores were marginally lower (4.06, 4.21, and 4.25). There were no significant differences when stratified by number of years in practice or specialty. Free text comments showed that 75% of physicians found the form helpful in oncoplastic BCS.Conclusions: The data indicate high feasibility, acceptability, and appropriateness of the BIO form. Results of this study suggest multidisciplinary benefits of implementing the BIO form in oncoplastic BCS. 2023 Elsevier Inc. All rights reserved.
Purpose of Review Neoadjuvant chemotherapy (NAC) utilization is an important part of breast cancer therapy. Recent advances call into question the optimal role of radiotherapy after NAC, as many radiation studies were performed without NAC. This review was conducted to understand the current data, outstanding questions and ongoing trials related to radiotherapy after NAC. Recent Findings Response to NAC is associated with promising clinical outcomes, particularly in triple-negative and HER2+ breast cancer. Retrospective data suggest that modification of radiotherapy based on tumor response to NAC may be appropriate, though caution is advised without prospective randomized evidence. NSABP B-51 and Alliance A011202 will investigate the management of nodal disease in this setting. Future trials will examine the optimal sequencing of treatments. Summary The personalization of adjuvant radiotherapy based on response to neoadjuvant chemotherapy is an attractive goal that is currently being evaluated in multiple clinical trials, including NSABP B-51.
OBJECTIVE:Observe patient-clinician communication to gain insight about the reasons underlying the choice of patients with unilateral breast cancer to undergo contralateral prophylactic mastectomy (CPM), despite lack of survival benefit, risk of harms, and cautions expressed by surgical guidelines and clinicians. METHODS & MEASURES:WORDS is a prospective study that explored patient-clinician communication and patient decision making. Participants recorded clinical visits through a downloadable mobile application. We analyzed 44 recordings from 22 patients: 9 who chose CPM, 8 who considered CPM but decided against it, and 5 who never considered CPM. We used abductive analysis combined with constructivist grounded theory methods. RESULTS:Decisions to undergo CPM are patient-driven and motivated by perceptions that CPM is the most aggressive, and therefore safest, treatment option available. These decisions are shaped not primarily by the content of conversations with clinicians, but by the history of cancer in patients' families, their own first-hand experiences with cancers among loved ones, fear for their children, and anxiety about cancer recurrence. CONCLUSION:The perception that CPM is the safest, most aggressive option strongly influences patients, despite scientific evidence to the contrary. Future efforts to address high CPM rates should focus on patient-driven decision making and cancer-related fears.
OBJECTIVE:Breast cancer survivors live longer due to more advanced cancer treatments; however, cardiovascular disease (CVD) is the leading non-cancer cause of death in breast cancer survivors. Previous studies have shown that depression is associated with an increased risk of CVD development. This study investigated whether depressive symptoms or mood disorder history, either independently or in combination with cardiotoxic treatments, predicted older cardiopulmonary age using a novel index-the Age Based on Exercise Stress Test (ABEST)-among breast cancer survivors. METHODS:Breast cancer survivors (N = 80, ages 26-72, stage I-IIIA) were assessed an average of 53 days (SD = 26) post-surgery, but before adjuvant treatment, and again an average of 32 (SD = 6) months thereafter. At both visits, they reported depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D), completed the Structured Clinical Interview for DSM-V, and engaged in an exercise stress test to obtain ABEST scores. RESULTS:Controlling for treatment type, age, education, trunk fat, antidepressant use, and time between visits, longitudinal analyses showed that breast cancer survivors with a mood disorder history had worsening ABEST scores over time, compared to their peers without this history (p = .046). Change in physical activity between Visits 1 and 2 did not mediate this relationship (95% CI: -0.16-0.51). Ancillary analyses provided some additional support for the primary finding, such that those with a mood disorder history trended toward greater decreases in Vo2max, although results were marginally non-significant (p = .095). There were no cross-sectional relationships between depressive symptoms or mood disorder history and ABEST scores (ps>.20). Treatment type did not modulate observed relationships (ps>.22). CONCLUSIONS:Breast cancer survivors with a mood disorder history may experience faster cardiopulmonary aging compared to their peers without such a history, raising risk for CVD.
About one-in-three breast cancer survivors have lingering cognitive complaints and objective cognitive impairment. Chronic inflammation and intestinal permeability (i.e., leaky gut), two risk factors for cognitive decline, can also fuel depression—another vulnerability for cognitive decline. The current study tested whether depression accompanied by high levels of inflammation or intestinal permeability predicted lower subjective and objective cognitive function in breast cancer survivors. We combined data from four breast cancer survivor studies (n = 613); some had repeated measurements for a total of 1015 study visits. All participants had a blood draw to obtain baseline measures of lipopolysaccharide binding protein—a measure of intestinal permeability, as well as three inflammatory markers that were incorporated into an inflammatory index: C-reactive protein, interleukin-6, and tumor necrosis factor-α. They reported depressive symptoms on the Center for Epidemiological Studies depression scale (CES-D), and a binary variable indicated clinically significant depressive symptoms (CES-D ≥ 16). The Kohli (749 observations) and the Breast Cancer Prevention Trial (591 observations) scales assessed subjective cognitive function. Objective cognitive function tests included the trail-making test, Hopkins verbal learning test, Conners continuous performance test, n-back test, FAS test, and animal-naming test (239–246 observations). Adjusting for education, age, BMI, cancer treatment type, time since treatment, study visit, and fatigue, women who had clinically elevated depressive symptoms accompanied by heightened inflammation or intestinal permeability reported poorer focus and marginally poorer memory. However, poorer performance across objective cognitive measures was not specific to inflammation-associated depression. Rather, there was some evidence of lower verbal fluency; poorer attention, verbal learning and memory, and working memory; and difficulties with visuospatial search among depressed survivors, regardless of inflammation. By themselves, inflammation and intestinal permeability less consistently predicted subjective or objective cognitive function. Breast cancer survivors with clinically significant depressive symptoms accompanied by either elevated inflammation or intestinal permeability may perceive greater cognitive difficulty, even though depression-related objective cognitive deficits may not be specific to inflammation- or leaky-gut-associated depression.
BACKGROUND:Inflammatory Breast Cancer (IBC) is a rare but aggressive subtype of breast cancer accounting for only 1% to 5% of cases but comprising 7% to 10% of breast cancer deaths. Diagnosis of IBC can be challenging which can lead to delays in diagnosis and treatment. We formed a multidisciplinary IBC program to address the unique challenges of diagnosing and treating patients with IBC. MATERIALS AND METHODS:We retrospectively identified patients with an IBC CPT code and collected data on the date of the first visit with medical oncology, surgical oncology, or radiation oncology, date of biopsy, and initiation of neoadjuvant chemotherapy. In 2020, as part of the IBC program at The Ohio State University, the decision tree (DT) was revised to help identify potential IBC patients. These patients were prioritized with a multidisciplinary appointment within 3 days. RESULTS:After adjusting the call center DT, there was a significant decline in the median and mean time from initial contact to chemotherapy initiation and an insignificant decrease in the mean time from contact to biopsy (P = .71884). The median time of contact to chemotherapy was 10 days (range 9-14) in 2020, a decrease of 43% compared to 3 prior years (P = .0068). After initiation of the IBC program, 100% of patients underwent trimodality therapy-neoadjuvant systemic therapy, modified radical mastectomy, and post mastectomy radiation therapy. CONCLUSION:A multidisciplinary IBC program that included scheduling DT with specific questions about IBC symptoms helped identify potential patients and significantly decrease time to treatment and assured completion of trimodality therapy.
Background: Genetic counseling and testing have an important role in the care of patients at elevated risk for breast cancer. However, conventional pre- and post-test genetic counseling is labor and time intensive, less accessible for patients living outside major urban centers, and impractical on a large scale. A patient-driven approach to genetic counseling and testing may increase access, improve patients' experiences, affect efficiency of clinical practice, and help meet workforce demand. The objective of this 2-arm randomized controlled trial is to determine the efficacy of Know Your Risk (KYR), a genetic counseling patient preference intervention.Methods: Females (n = 1000) at elevated risk (>20% lifetime) for breast cancer will be randomized to the KYR intervention or conventional genetic counseling. The study will provide comprehensive assessment of breast cancer risk by multigene panel testing and validated polygenic risk score. Primary outcome is adherence to National Comprehensive Cancer Network guidelines for a clinical encounter every 6-12 months and an annual mammogram (breast MRI if recommended) determined by medical record review. Secondary outcomes include adherence to other recommended cancer screening tests determined by medical record review and changes in breast cancer knowledge, perception of risk, post-test/counseling distress, and satisfaction with counseling by completion of three surveys during the study. Study aims will be evaluated for non-inferiority of the KYR intervention compared to conventional genetic counseling.Conclusion: If efficacious, the KYR intervention has the potential to improve patients' experience and may change how genetic counseling is delivered, inform best practices, and reduce workforce burden.