bluuebunny/crossref_metadata_2025 huggingface dataset:
Adverse event clusters present at dose-reduction in CLL patients on ibrutinib in the U.S. Veterans Health Administration.
Authors: Frei Christopher R , Ryan Kellie , Le Hannah , McHugh Daniel , Obodozie-Ofoegbu Obiageri O , Teng Chengwen , Jones Xavier , Galley Samantha , Franklin Kathleen , Tavera Juan , Janania Martinez Michelle , Gregorio David , Ananth Snegha , Uribe Ricardo , Surapaneni Prathibha , Espinoza-Gutarra Manuel Ricardo , Song Michael , Nooruddin Zohra
Published: October 2020

252

Background: Previously, we reported that adverse events (AEs) were the top reason for dose reductions in VHA patients on novel agents. Some AEs might be problematic but might not directly lead to dose reduction; however, these concomitant AEs should not be overlooked. This study describes AE clusters that occurred with the primary AE that led to dose reduction in VHA CLL patients receiving ibrutinib. Methods: This is a retrospective chart review study of CLL patients treated with ibrutinib in the VHA from October 2013 to March 2018. Variables included the presence of dose reduction, the reasons for dose reduction, primary AEs leading to dose reduction, and concomitant AEs present at the time of dose reduction. Descriptive statistics were used to summarize AE clusters. Results: Out of 1069 CLL patients on ibrutinib, 285 patients experienced dose reduction due to AEs and were included in this analysis. The most common AEs leading to dose reduction were: musculoskeletal (11%), bleeding (11%), fatigue (10%), infection (9%), atrial fibrillation (8%), diarrhea (8%), and rash (8%). Fatigue was the leading concomitant AE present at dose reduction among patients who were dose reduced due to musculoskeletal (18%), infection (12%), diarrhea (18%), and rash (25%). Fatigue was also the second-leading or third leading concomitant AE among those who were dose reduced due to atrial fibrillation (13%) or bleeding (10%). Musculoskeletal was the leading or second-leading concomitant AE present at dose reduction among those who were dose reduced due to fatigue (17%), infection (12%), or diarrhea (14%). Bleeding was the leading concomitant AE among those who were dose reduced due to atrial fibrillation (17%) and vice versa. Conclusions: This study provides evidence that fatigue and musculoskeletal AEs are problematic in CLL patients on ibrutinib in the VHA. These were not only among the most common primary AEs but also the leading concomitant AEs present at dose reduction. Although not directly leading to dose reduction, these ‘nuisance’ AEs can greatly affect quality of life among CLL patients and warrant more attention from clinicians. A better understanding of all AEs present at dose reduction may help clinicians better manage patients on novel agents. These data also highlight the unmet need for novel agents with a ‘cleaner’ safety profile.
Use of antiemetic prophylaxis and oral breakthrough medication for highly emetogenic chemotherapy (HEC) in a large community oncology network.
Authors: Young Garrett , Schleicher Stephen Matthew , Arrowsmith Edward , McCullough Stacey , Richey Sylvia S. , Blakely Johnetta , Dickson Natalie R. , Schwartzberg Lee S.
Published: October 2020

253

Background: Prophylaxis for highly emetogenic chemotherapy (HEC) is well established in clinical guidelines, but real-world treatment patterns are unclear. Today, consistent use of prophylaxis is more easily accomplished due to the incorporation of ordering premeds into the workflow prior to administration of intravenous chemotherapy. However, prescription of oral agents for treatment of breakthrough chemotherapy induced nausea and vomiting (CINV) is less consistent and standardized and has a scant evidence base. In an effort to standardize utilization, we evaluated the use of prophylaxis and oral breakthrough medications in a large national community oncology network. Methods: Data from electronic medical records at five practices comprising over 100 clinic sites was analyzed to examine the frequency of guideline-recommended triplet 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid use for prophylaxis prior to the administration of HEC agents. Oral breakthrough medication use and preference was also analyzed. Data was collected and analyzed at the practice level. Results: We identified 2645 patients that received HEC between 1/1/2019 and 5/8/2020. We found consistently high utilization of guideline-concordant triplet prophylaxis regimens for patients receiving HEC, ranging from 90-100% at each of the five practices. In addition, most patients (mean 83%, range 67% - 94%) received a prescription for at least one oral breakthrough medication, but the agent(s) utilized varied widely across practices (Table). Ondansetron was the most commonly prescribed oral breakthrough medication (mean 68%, range 53% - 88%), while olanzapine use for either prophylaxis or breakthrough CINV across practices ranged from 1% - 4%. Conclusions: In this national community oncology network, standard recommended triplet agent prophylaxis for HEC was delivered successfully. However, opportunity exists to increase appropriate use of olanzapine and reduce variation of oral breakthrough antiemetic medications in order to optimize clinical care. [Table: see text]
The role of telehealth in improving patient care and satisfaction during a pandemic: University of California Cancer Consortium experience.
Authors: Cinar Pelin , Burgess Debra , Gold Kathryn A. , Yamamoto Maki , Ternavan Kimberly A. , Kamiya Emi
Published: October 2020

258

Background: The adoption of telemedicine in providing patient-centric care has been limited due to concerns related to upfront cost and the uncertain reimbursement models. Telehealth modalities, which encompass broader services, quickly became a central focus of how we delivered care in cancer centers across the nation during the COVID-19 (C19) pandemic. Our aim is to describe five University of California (UC) Cancer Centers’ experience with telehealth during the pandemic. Methods: Between March and June 2020, UC Cancer Centers developed or increased the use of telehealth modalities to continue to provide care to our oncology patients during the pandemic. Digital platforms were used to screen for symptoms and exposures related to C19, as well as for symptoms of distress. In addition, providers performed remote visits via video and telephone visits. Each of our centers monitored visit volumes as well as patient satisfaction scores during the pandemic. Results: Our Cancer Centers, each with various levels of pre-pandemic (Jan-Feb) use of telehealth, saw an increase in the volume of patients who were seen via remote visits including video and telephone visits during the pandemic (Mar-Apr). UC Davis, UC Los Angeles and UC San Francisco had implemented telemedicine prior to the pandemic, but the rates of use were 1%, 0.4% and 7%, respectively. In contrast, UC Irvine and UC San Diego did not offer remote visits prior to the pandemic. Despite these differences, during the pandemic, telemedicine rates increased to 50-70% of visits in the cancer centers. In addition, patient satisfaction scores were comparable to in-clinic visits. The use of digital platforms allowed 80% of patients to be screened for risk of C19 prior to their in-clinic visits. Conclusions: While differing levels of implementation was in place for telehealth services in our cancer centers prior to the pandemic, each cancer center was able to continue to see patients via remote visits. In addition, telehealth technology automated activities that would have been performed manually pre-pandemic. The increased use of telemedicine visits with high patient satisfaction scores is an indication that some patients can continue to receive their care via telehealth beyond the pandemic.
Implementing clinic to home telehealth services to promote quality of life for ambulatory oncology palliative care patients.
Authors: Begnoche Megan , Guyer Dana , Korber Susan F. , Fenton Mary Anne
Published: October 2020

259

Background: The Lifespan Cancer Institute (LCI) identified strategies to improve the palliative care experience and outcomes by providing clinic to home telehealth services. LCI is an integrated academic medical center program combining three hospital programs operating at five outpatient sites. One quality goal is to embed and increase palliative care within the fabric of oncology by providing palliative telehealth in the home to avoid office visits, ED and hospital admissions. Methods: LCI’s multidisciplinary palliative care team, including administrators, physicians, advanced practice providers and community partner physicians assessed telehealth challenges with a vulnerable patient in the home setting. Process development included operations, technology, patient and staff education. The group modified existing Lifespan system workflows, clinic to clinic video for behavioral health and clinic to clinic for providers, to create the clinic to home method. This process benchmarked patient and behavioral health noting video differences with the clinic setting versus the home. Results: Outcome metrics include no show rate, chemotherapy within 14 days of death, ED/ICU within 30 days of death, patient and provider experience. Initial data shows no show rates decreased from 10% (January) to 6% (May) as telehealth increased. Patients marked deceased within 3 months of a LCI visit for January (n = 52) and May ( = 61) unfortunately did not have a negative trend for chemotherapy in the last 14 days of life (Jan: 8%, May 15%). ED and ICU visits both had modest decreases from January (ED 50%, ICU 29%) to May (ED 48%, ICU 21%). In anticipation of future Press Ganey results, patient feedback includes an increase of comfort while at home. Provider satisfaction increased with the ability to assess the patient in their own home instead of the sterile clinic environment. Encountered challenges include insurance restrictions for Rhode Island (not a rural state), technology, and remote trouble shooting. Conclusions: The success of clinic-to-home telehealth services set the foundation for the COVID-19 telehealth insurgence and led to the palliative team acting as role models to medical and radiation oncology. End of life oncology patients stayed home while having their palliative needs addressed remotely. The innovative approach to implementing telehealth services will serve as a model for future LCI telehealth programs including treatment education sessions, oral chemotherapy follow-up, survivorship and post hospital discharge assessments.
Active Living After Cancer: Converting a group physical activity intervention for cancer survivors to a virtual format in response to the coronavirus pandemic.
Authors: Basen-Engquist Karen , Liao Yue
Published: October 2020

261

Background: Active Living After Cancer (ALAC) is an evidence-based group program to help cancer survivors improve their physical functioning and quality of life through increasing physical activity. It has enrolled over 800 cancer survivors in the Houston and El Paso areas. The program prioritizes serving minority and medically underserved survivors and is offered in both English and Spanish. As a result of the coronavirus pandemic we converted the program to a virtual format. Here we report preliminary data on the outcomes of the virtual program. Methods: ALAC teaches cognitive and behavioral skills for increasing physical activity to cancer survivors through 12 group sessions. We converted the group sessions to a virtual format using the Zoom platform. Group attendance was monitored by health educators teaching the program, and participants completed questionnaires and did a 30-sec sit-to-stand test before and after the program to assess outcomes (physical activity, quality of life, physical functioning, program satisfaction). We compared outcomes for the virtual groups to those of previous in-person groups. Results: Five classes with 32 participants were started as in-person groups and converted to virtual. The dropout rate was higher (37.5%) in the virtual groups, compared to in-person groups (23.1%). However, both in-person and virtual group participants showed similar increases in physical activity, physical functioning, physical quality of life, and had high satisfaction (see table). Conclusions: Preliminary data indicate that the virtual format is feasible and produces similar outcomes when compared to the in-person format, although drop-out is higher in the virtual format. Virtual group participants may experience fewer mental health benefits (although this could be due to the stress of the pandemic). Additional analyses will include current participants who are completing all sessions virtually. [Table: see text]
Telemedicine usability for cancer care during the COVID-19 pandemic.
Authors: Miller Christian , Kaltman Rebecca Davidson , Leon Andrea , Gesteira Andrea , Duffy Samuel , Burgess Paula Brooke
Published: October 2020

265

Background: Healthcare delivery via telemedicine has increased substantially amid COVID-19. The George Washington Cancer Center (GWCC) now provides cancer care services via tele-visits for patients at high risk of morbidity and mortality secondary to COVID-19. This study was performed to assess usability of virtual cancer care delivery for patients and providers across specialties. Methods: Participants included patients and providers surveyed to assess baseline usability after initiating tele-visits. Surveys included demographics, Telehealth Usability Questionnaire (TUQ), and questions on perceived safety and preferences around telemedicine. Subjects also provided open-ended feedback for quality improvement. Results: For patients (n = 105), 96% of surveys sent were completed and analyzed. Most patients were ages 50-59 (22%), 60-69 (25%), 70-79 (25%). Breast cancer (38%) was the most commonly reported cancer type. Median patient TUQ scores were: 5/5 for Interaction Quality (ItQ) and Ease of Use (EU), 4/5 for Usefulness (U), Interface Quality (IfQ) and Satisfaction (S), and 3/5 for Reliability (R). No association was found between TUQ scores and age groups (p = 0.15), sex (p = 0.69), or timing of diagnosis in relation to telemedicine visit (p = 0.67). Compared to in-person visits, 70% of patients agreed/strongly agreed that telemedicine made them feel safer, 63% agreed/strongly agreed that it reduced stress, and 59% expressed interest in using it with other medical specialties. For providers (n = 85), 88% of surveys sent were completed and analyzed. Most providers were ages 30-39 (37%), 50-59 (23%), and 47% had 50 or more experiences with telemedicine. The predominant specialty participating was Internal Medicine (31%). Median provider TUQ scores were 4/5 for ItQ, EU, U, IfQ and S, and 2/5 for R. No association was found between TUQ scores and experience with telemedicine (p = 0.31), though providers aged 60-79 had significantly more negative views of telemedicine (p = 0.02) as compared to other age groups. The majority (97%) agreed/strongly agreed that telemedicine improves access to care, yet 57% expressed concern about missing something they may have caught in person. Conclusions: The use of telemedicine in cancer care was perceived favorably by patients and providers. All patient groups scored highly on perceived safety, reduced stress and improved access, independently of subject characteristics. Providers demonstrated some dissent, particularly in older age groups. These findings provide a useful benchmark for advancement of virtual care delivery in cancer care.
Trends in germline genetic testing and results into survivorship for women diagnosed with breast cancer or ovarian cancer, 2013 to 2017.
Authors: Katz Steven J. , Morrow Monica , Kurian Allison W.
Published: October 2020

273

Background: Genetic testing is increasingly central to breast and ovarian cancer prevention and treatment. Yet, little is known about trends and disparities in receipt of testing and test results after diagnosis. Methods: We linked all female patients with breast or ovarian cancer diagnosed from 2013-2017 in Georgia and California and reported to SEER registries to genetic testing results from four laboratories (Ambry Genetics, GeneDx, Invitae, Myriad Genetics). We combined test results from all labs with SEER data. We classified a test as a multigene panel (MGP) if it included other genes in addition to BRCA1/2. We grouped pathogenic variants (PVs) by level of evidence that supported clinical testing: BRCA1/2; other genes associated with well-established syndromes (syndromic genes); genes whose cancer association is less certain (emerging genes); and any other tested genes (other genes). We categorized patients with a variant of unknown significance (VUS) in any gene but no PVs as VUS-only. We examined trends in receipt of testing and test results overall and by race/ethnic groups. Results: One quarter (25.5%) of 198,001 breast cancer patients, and 34.5% of 15,461 ovarian cancer patients had genetic tests. Test rates increased by only 2% annually; while the number of genes tested per patient increased by 28%. The mean number of genes tested rose from 10 to 35 during the study period. In early 2013, 18.3% of testers had a PV or VUS result, which increased to 37.2% in late 2017. The upward trend was largely due to increase in VUS-only findings. The proportion of tested breast cancer patients with any PV increased from 9.1% to 9.9%: PVs in BRCA1/2 decreased from 7.5% to 5.0% (p<.001), while PV yield for the two other clinical categories (syndromic and emerging genes) increased from 1.6% to 4.9% (p<.001). PVs in any of the other 61 genes were very rare (<1%). By contrast, the VUS rate in breast cancer patients increased markedly from 9.6% in 2013 to 26.2% in 2017. The VUS rate was higher in racial/ethnic minorities (41.0% Asian, 36.5%% Black, 28.0% Latinas versus 25.6% non-Hispanic Whites diagnosed in 2017; p<.001). We observed similar findings for patients with ovarian cancer. Conclusions: A large gap persists in testing ovarian cancer patients (35% versus 100% recommended). Testing more genes per patient was associated with a substantial racial/ethnic gap in VUS with little difference in yield on clinically relevant PVs. Testing a limited subset of genes may optimize yield-to-noise of genetic testing, particularly for racial/ethnic minorities.
Treatment patterns of advanced or recurrent endometrial cancer following platinum-based therapy in the U.S. real-world setting.
Authors: Klink Andrew J. , DeMars Leslie , Huang Joice , Maiese Eric M. , Feinberg Bruce A. , Hurteau Jean
Published: October 2020

274

Background: Patient (pt) prognosis is poor following disease progression on or after primary (1L) platinum-based therapy (PBT) for advanced/recurrent (A/R) endometrial cancer (EC), and no consensus on standard second-line (2L) therapy exists. This retrospective analysis aimed to understand real-world (RW) treatment patterns of pts with A/R mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) EC who progressed after 1L PBT. Methods: Physicians in Cardinal Health’s Oncology Provider Extended Network submitted retrospective data by abstracting outpatient electronic medical records of pts who received systemic treatment for A/R EC following PBT from 2016 to 2018. Demographics, clinical characteristics, treatments, and outcomes were summarized descriptively. Results: This study included 84 pts with A/R dMMR/MSI-H EC (table). The majority of participating physicians were hematologists/medical oncologists (80%) and practiced in the community setting (70%). Median duration of therapy (mDOT) in 1L was 4.9 months (95% CI, 4.47–5.57); 64% of pts discontinued treatment due to completion and 35% due to disease progression. In contrast, mDOT in 2L was 6.2 months (95% CI, 5.40–6.37); 37% of pts discontinued treatment due to completion and 44% due to disease progression. The most common MMR/MSI testing modalities were next-generation sequencing (NGS) only, immunohistochemistry (IHC) only, and polymerase chain reaction (PCR) only (table). Conclusions: RW treatment patterns in pts with A/R dMMR/MSI-H EC show that most will undergo PBT retreatment. However, progression is the main reason for discontinuation during retreatment. An urgent need exists for durable therapies that improve prognosis. Opportunities to improve timely testing of MMR/MSI exist. Funding: GlaxoSmithKline, Waltham, MA, USA. [Table: see text]
Concordance of MRI-guided and systematic prostate biopsy for the detection of prostate cancer (PCa).
Authors: Parsons Matthew , Foy Bridget , Chan Ernest , Crawford Bryan , Sommers Daniel , Bishoff Jay , Lynch Steven C , Romney Benjamin , Gill David Michael , McLean Logan
Published: October 2020

277

Background: MRI/US guided biopsy (fusion biopsy) is increasingly utilized over systemic 12-core transrectal ultrasound biopsy (12-core biopsy) for men with MRI-visible prostate lesions. Methods: Patients with MRI visible prostate lesions who underwent fusion and 12-core biopsy from 2016-2020 in the Intermountain Healthcare (IHC) system were consecutively analyzed. This was in the setting of a continuous quality assurance initiative among the reading radiologists. Primary outcome was PCa detection defined by Gleason grade group (GGG) 1 or higher. Clinically significant cancer (CSC) was defined as GGG 2 or higher. Patients were stratified by date biopsy was performed, 2016-2017 and 2018-2020, and lesions were stratified by PI-RADS v2 category. For men with multiple lesions, the highest PI-RADS v2 category lesion was used. Results: A total of 142 men with 254 MRI-detectable lesions underwent both fusion and 12-core biopsies in the IHC system from 2016 to 2020. CSC was detected in 21.6% (55/254) of fusion biopsies. Comparing PI-RAD v2 categories 1-3 to PI-RADS v2 categories 4-5, the PPV for detecting CSC was 9% (15/162) compared to 44% (40/92) respectively. Fusion and 12-core biopsies were concordant for any PCa in 79% of men (112/142) and CSC in 83% (118/142). Fusion biopsy detected any PCa in 22/84 (26%) and CSC in 15/103 (15%) of men in whom 12-core biopsy was negative. 12-core biopsy detected any PCa in 8/70 (11%) and CSC in 9/97 (9%) of men in whom fusion was negative. In total, 15 patients (11%) had a CSC that would have been missed if fusion biopsy was omitted while 9 (6%) had a CSC that would have been missed without 12-core biopsy. Conclusions: Omitting fusion or 12-core biopsy for PI-RADS v2 lesions would have resulted in a missed CSC in 11% or 6% of patients from 2016-20, respectively. The combination of MRI/US-guided fusion biopsy and systematic 12-core biopsy increased detection rate of CSC. These results are in the setting of a continuous, multi-disciplinary quality assurance program and results are not necessarily applicable to other healthcare systems. [Table: see text]
Biomarker testing patterns and use of targeted therapy in Medicare Fee-for-Service (FFS) beneficiaries newly diagnosed with metastatic non-small cell lung cancer (mNSCLC).
Authors: Patel Anik , Jamotte Aurelien , Matsuda Tara , Das Partha Manas , Elkhouly Ehab , Xi Ann , Jones Barton , Murunga Anne , Petrilla Allison , Markward Nathan , Stevinson Kendall Lee
Published: October 2020

278

Background: The number of targeted therapies approved for treatment of mNSCLC has increased over the past 5 years. Strategies to identify eligible patients with actionable mutations for targeted therapy include simultaneous testing of ≥ 2 genes via next generation sequencing (NGS) or multiple simultaneous gene testing (MSGT) and sequential single gene testing (SSGT). Current clinical practice guidelines strongly recommend broad molecular profiling in all patients for the simultaneous assessment of multiple genes, including EGFR, ALK and ROS1, that may have potential roles in cancer development. Limited real-world (RW) evidence is available describing the uptake of these strategies and receipt of targeted therapy. Methods: Medicare beneficiaries age 65 years or older, newly diagnosed with mNSCLC and tested for mutations of interest in mNSCLC (ALK, EGFR, ROS1, BRAF, HER2, KRAS, MET, NTRK, RET) from July 2014 - June 2018 were identified using Medicare FFS claims (100% sample) linked to biomarker results in PROGNOS NSCLC Explorer. Patients were followed from date of first metastatic diagnosis and stratified by line of therapy, testing strategy, and year of mNSCLC diagnosis. Those testing positive for an actionable biomarker were identified and then segmented by timing of receipt of a subsequent targeted therapy. Results: 12,272 beneficiaries met inclusion criteria: median age: 75 years, 51% were female, 86% white. Among mNSCLC patients with at least one biomarker test result, EGFR and ALK mutation status were the most commonly tested and reported in 85% and 63% respectively. Overall, 1540 (12.5%) tested positive for EGFR, ALK or ROS1. The relative use of NGS or MSGT vs. SSGT for biomarker testing increased over time, from 63% in 2014 to 80% in 2018. During this period, 789 patients were identified as having at least one positive biomarker test result prior to initiating 1L therapy: 635 were identified via NGS or MSGT while 154 were identified via SSGT. Despite a positive test for mutations of interest, only 292 patients received a targeted drug at 1L. Conclusions: This RW study of mNSCLC patients demonstrates an increasing trend to test patients for multiple biomarkers at once via NGS or other MSGT methods. The number of patients receiving appropriate targeted therapies was low, suggesting the need to address the barriers to administration of guideline-recommended therapy.
Palliative care referrals in patients with advanced cancer on early-phase cancer clinical trials (EP-CTs).
Authors: Healy Megan , Jimenez Rachel , Nipp Ryan David , Shin Jennifer Adrienne , Johnson Andrew , Capasso Virginia , McIntyre Casandra , Cashavelly Barbara J. , Juric Dejan , Lundquist Debra
Published: October 2020

29

Background: EP-CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the utilization of supportive care services, specifically palliative care (PC), in this population. Methods: We conducted a retrospective review of consecutive patients enrolled on EP-CTs at the MGH Cancer Center from 2017-2019. Sociodemographic and clinical variables, including utilization of PC services, were obtained via chart review. Details of the PC evaluation were compared between patients who received first referral to PC while enrolled on an EP-CT versus those who received a PC referral at any point after diagnosis. Results: Among 426 patients enrolled on EP-CTs (median age 63 years; 44% male), 249 (59%) received a PC referral at any time following a diagnosis of cancer (median age 57 years, 58% male). Eighty-six (35%) were referred prior to enrollment on EP-CT, 44 (18%) were referred while on EP-CT, and 119 (48%) were referred post-EP-CT. Patients referred on EP-CT were younger (median 56 vs 63 years, p < 0.0001) than those enrolled on EP-CTs. For patients referred while on EP-CT, 48% had a PC consult within 30 days of enrollment (range: 0-530 days); median number of PC visits was 3 (range: 0-37); median time from first PC consult to death or termination of EP-CT was 32 days (range: 1-213). Of 44 patients referred on EP-CT, 2 (5%) died while on EP-CT. Of the remaining patients, median time from first PC consult to date of death was 79 days (IQR: 45-178 days). Most common reasons for referral included pain (22, 50%), non-pain symptoms (21, 48%), and goals of care/advanced care planning (20, 45%). Of these referrals, 13 (30%) were initiated as inpatients versus 31 (70%) as outpatients. Pain was most commonly cited for outpatient referral (35%), followed by non-pain symptoms (25%) and goals of care (23%). Non-pain symptoms (40%) and goals of care (36%) were most commonly cited reasons for inpatient referral, followed by pain (24%). Of referrals while on EP-CT, 23 (52%) were made by EP-CT staff, including MD and APP, 7 (16%) from the primary oncologist, and 1 (2%) was self-referral. 26 (57%) of patients referred to PC during trial were also referred to hospice, with a median time from last PC consult to hospice referral of 24 days (range: -2-322). Conclusions: A majority of patients with advanced cancer enrolled on EP-CTs received a PC referral. The timeline and method of referral varied, but most patients did not receive a referral until or following enrollment on an EP-CT. Future work will focus on developing a standard referral protocol for patients enrolled on EP-CTs.
Oncologist experiences regarding patient-recorded clinical encounters: Implications for the patient-doctor relationship.
Authors: Jimenez Rachel , Johnson Andrew , Horick Nora K. , Hlubocky Fay J. , Lei Yvonne Y. , Matsen Cindy Brown , Mayer Erica L. , Collyar Deborah E. , LeBlanc Thomas William , Donelan Karen , Mello Michelle , Peppercorn Jeffrey M.
Published: October 2020

290

Background: The high prevalence of smartphone use means that most patients can easily audio record medical consultations. Oncologists’ attitudes towards recording visits are unknown yet may impact patient care. Methods: A mail survey of oncologists practicing at 5 U.S. Alliance for Clinical Trials in Oncology sites collected information on clinicians’ beliefs, preferences, and practices regarding patient-initiated recordings, along with sociodemographic and practice characteristics. Descriptive statistics and bivariate analyses were calculated. Results: Of 523 eligible oncologists, 352 (67%) completed the survey. Median age was 47 years, 33% were female, and 86% worked in an academic setting. 53% were medical oncologists, 30% surgical oncologists, and 17% radiation oncologists. Virtually all (93%) reported experience with patients recording visits, 79% at least weekly. The majority (74%) perceived that patients record visits in order to help understand treatment choices. While 79% reported that they “always” agree to recordings, 26% reported discomfort. Nearly one-third (29%) reported concerns about liability, 26% felt recording made discussion less natural, and 18% felt recording changed the way they conveyed information. Although 86% agreed that patients have the right to record visits, nearly all felt physician permission was required and 53% reported having been previously recorded without permission. Only 51% believed recording had a positive impact on the patient-doctor relationship. One-quarter (28%) felt that recording led to a less detailed conversation and 33% felt it contributed to avoidance of difficult topics, such as prognosis. Most preferred the patient/family taking notes or having access to a written summary. Views did not vary significantly based on practice setting, specialty, or region of the country. Older age and greater years in practice were associated with both greater comfort with recording and the perception that recording has a positive impact on the patient-doctor relationship (p < 0.001). Conclusions: While most oncologists report comfort with audio recording and recognize benefits for patients, a substantial minority have reservations about its impact on clinical discussions and their liability exposure. Adopting clear institutional policies about recording could help address some concerns, such as surreptitious recording, while ensuring that patients’ interests are served.
Identifying resources available to physicians for management of financial toxicity: A Fellow-driven QI initiative.
Authors: Fischer Katrina , Anand Sidharth , Walling Anne M. , Larson Sarah Marie , Glaspy John
Published: October 2020

294

Background: Insufficient patient-physician cost communication stems in part from limited physician awareness of actionable interventions when cost issues arise. Oncologists report low awareness of resources to help patients with financial toxicity and often feel underprepared to discuss and navigate this issue. Methods: All oncology fellows (n = 19) at the University of California, Los Angeles were invited to participate in QI project during the fall of 2019. As part of the curriculum, fellows were individually paired with an experienced attending and asked to review a hypothetical case of financial toxicity. The case described an elderly widow on Medicare, living hours from the cancer center who was non-adherent to her oral cancer therapy due to high copays. Participants were asked to identify at least four financial toxicity risk factors in the case, and to identify resources and strategies that a physician could use help navigate her financial concerns. A cost-health literacy survey was administered at baseline and at the conclusion of the curriculum to evaluate the impact of the program. Results: Of 19 participants, 16 completed the case based scenario. Nine categories of risk factors were identified (63% of participants identified an insurance issue, 44% lack of social support, 44% drug cost, 50% fixed income, 50% distance from treatment center, 31% logistical transportation concern). Physician directed solutions were primarily focused on three categories: drug cost, insurance issue, and transportation concerns. Together, an institutional specific financial toxicity tip sheet was generated for further dispersal at the cancer center. After participation in the intervention, more fellows agreed/strongly agreed that they could help a patient experiencing financial toxicity (62% v 6%, p = 0.005). Conclusions: A focused intervention can increase awareness of resources and strategies available to physicians in the management of patient financial concerns, which may impact physician engagement with issues of financial toxicity. Standardized education programs to further educate physicians on financial toxicity management strategies is warranted.
Development of self-management tip sheets for medical oncology and surgical patients electronically reporting symptoms in the home-care recovery setting.
Authors: Schrag Deborah , Osarogiagbon Raymond U. , Wong Sandra L. , Hazard Hannah , Bian Jessica J , Dizon Don S. , Cronin Christine , Hassett Michael J. ,   eSyM Project Managers
Published: October 2020

299

Background: Patients receiving cancer treatments, including chemotherapy and surgery, often face immense morbidities. Poor symptom control frequently leads to decreased quality of life and an increased need for acute care services. For patients undergoing chemo, adverse side effects can deter them from receiving life-saving therapies. Similarly, poorly managed postoperative symptoms can delay recovery and timely receipt of adjuvant therapies. Empowering patients to proactively monitor, electronically report, and effectively treat symptoms in the home-care setting is critical to improving clinical outcomes. Methods: Through the NCI’s Moonshot-funded IMPACT consortium, 6 health systems developed a library of 70 open source symptom management tip sheets for medical oncology and surgical patients. The study team went through an iterative process with medical oncologists, surgeons, practice nurses, health educators, and patient advocates. Careful attention was paid to minimize the usage of regional dialects or idioms to ensure scalability and acceptability. The tip sheets achieved passing scores on two validated healthy literacy and readability tools. Results: Tip sheets were accessible to patients participating in the novel eSyM (electronic symptom management) program, a fully EHR-integrated ePRO model.eSyM and the incorporated tips were deployed at four health systems between fall 2019 and spring 2020 (Baptist Cancer Center, West Virginia University, Dartmouth-Hitchcock Medical Center, and Maine Medical Center). Patients enrolled in eSyM had access to the tip sheet library through their patient portal and could view them at any time. In addition, after completing an ePRO questionnaire, patients were given dedicated links to the tips for symptoms they reported. Each developed tip sheet included 4 sections: 1) things you can do on your own, 2) with over-the-counter medications, 3) with the help of your care team, 4) when to call your care team for help. This simplified structure allowed patients to determine how to manage symptoms on their own and when to seek out assistance. Conclusions: Presenting self-management tip sheets in response to patient-reported symptoms through a fully integrated patient portal platform is a novel approach to symptom management. Future efforts will include deploying the library and platform at two additional health institutions and evaluating the adoption, acceptability, and utilization of the tip sheets and their impact on clinical care outcomes.
Costs to healthcare payers associated with clinical trial (CT) participation in metastatic non-small cell lung cancer (NSCLC).
Authors: Merkhofer Cristina , Chennupati Shasank , Sun Qin , Eaton Keith D. , Martins Renato G. , Ramsey Scott David , Goulart Bernardo H. L.
Published: October 2020

3

Background: To assess the financial implications of therapeutic CT participation for healthcare payers, we compared first-line (1L) and second-line (2L) total direct medical costs between patients enrolled in 2L CT vs non-CT participants receiving 2L therapy for metastatic NSCLC. Methods: We linked electronic health records from a single academic center with tumor registry and claims data to identify patients with metastatic NSCLC diagnosed from 1/1/2007-12/31/2015. Eligibility criteria included 60 day minimum survival, receipt of ≥ 1 anti-cancer drug within 180 days of diagnosis, insurance enrollment for ≥ 12 months after diagnosis and receipt of ≥ 2 therapy lines. Patients on 1L trials were excluded. We calculated mean per-patient-per-month (PPPM) total direct medical costs from the payer perspective for 1L and 2L. We performed a difference-of-difference analysis to estimate the effect of trial enrollment on costs by calculating the mean PPPM difference between 2L and 1L in trial (Diff trial) and non-trial enrollees (Diff non-trial). Then we calculated the difference between Diff trial and Diff non-trial. We used paired and non-paired t-tests for statistical comparisons and report all costs in 2019 US dollars. Results: Of 63 patients, 22 (35%) enrolled in a 2L CT. CT enrollees were younger (mean age 63.5 vs 66.7 years), female (73% vs 41%), had commercial insurance (36% vs 32%), were never smokers (36% vs 32%), had EGFR mutations (27% vs 22%) and fewer had brain metastases (14% vs 29%). The mean PPPM total direct medical costs decreased between 2L and 1L for patients enrolled in 2L CTs but increased in non-trial participants (Diff trial = -$5,585, SD ± $6,541; Diff non-trial = $1,532, SD ± $14,739). The mean difference of difference (Diff trial - Diff non-trial) was -$7,117 (p = 0.01; Table). Conclusions: This small observational study suggests that CT enrollment results in substantial cost-savings to payers. If confirmed in larger studies, our findings suggest that insurers support trial participation for patients with NSCLC. [Table: see text]
Impact of curated data on electronic quality measure capture rates within CancerLinQ.
Authors: Rios Katrina Caridad , Thakkalapally Arpitha , Koskimaki Jacob , Riffon Mark , Miller Robert S. , Komatsoulis George Anthony , Potter Danielle
Published: October 2020

307

Background: Accurate calculation of key quality measures is critical for informing high-quality, value-based cancer care that is consistent with clinical guidelines. The American Society of Clinical Oncology (ASCO)’s CancerLinQ enables oncology organizations around the US to view near-real time quality measure dashboards sourced from structured electronic medical record (EMR) data; however, use of structured data in key fields is highly variable. Unstructured content, such as progress notes, contains important clinical information on treatment and disease status, which can then undergo curation. This process involves trained data abstractors searching for key data elements through a combination of manual review and natural language processing (NLP) to extract structured data from unstructured content. We hypothesize inclusion of curated data substantially augments structured data alone by more accurately representing the patient journey, thus improving validity of quality measures across EMRs. Methods: A total of 96,399 records across 57,232 patients from 4 EMRs vendors were analyzed from 2018-2019 across structured EMR and curated data. Each record represents 1 of 7 key data elements used to calculate the Staging Documented within One Month of First Office Visit quality measure. Structured documentation of these data elements determines if a patient is concordant with the measure, meaning they were staged within 31 days of their first visit after diagnosis, or non-concordant, meaning they were not staged within the appropriate window. Results: More than a quarter of records from patients concordant or non-concordant with the measure (28.85%) had key data elements sourced from curation. In total, 33% of all records among concordant patients were sourced from curation. Relying on structured data alone would show only 67% concordance versus 97.5% concordance among curated records. This demonstrates that appropriate care may often be delivered but documentation may be missing in a significant fraction of structured EMR data, thus limiting accurate reporting capabilities. Conclusions: NLP-assisted curation can meaningfully supplement structured EMR data by providing a more accurate picture of care rendered, which can have substantial impacts on clinical care, quality reporting, and business operations. [Table: see text]
Tag you’re it! Development of a clinical decision support tool to identify NCCN regimens without a costly pathways program.
Authors: Bhardwaj Aarti Sonia , Gu Edward , Hernandez Damaris Peralta , McLean Michael , Theroux Haley Hines , Smith Cardinale B.
Published: October 2020

308

Background: Reducing variation in care can improve outcomes and decrease costs. Evidence based medicine drives cancer guidelines and adherence promotes quality cancer care. Value based programs are based on adherence to pathways. Most institutions adopt costly cloud based clinical pathways products but none are mature products that fully integrate with the EHR and they require additional data entry. We present our simple Clinical Decision Support (CDS) tool for identifying best practice treatment protocols driven by the cancer diagnosis in the EMR for our large, multi-site, mixed academic and community cancer system. Methods: Our chemotherapy council must approve all protocols that are published in the system’s Epic Beacon library using a rigorous scoring system based on level of evidence and FDA or NCCN approval. Then each protocol is “tagged” appropriately: “Tier 1A”: Preferred Regimens/NCCN Approved; “Tier 1B”: Preferred Regimens/Chemo Council Approved (but not NCCN Approved); Tier 2: Specific Disease Management Team approved regimens; and finally “Other” or research protocols. When the oncologist enters the treatment plan in EPIC, a list of protocols are suggested, ordered by level of evidence, based on the cancer diagnosis and with the easily visible level of evidence or “tag” to allow data driven decision making. Results: We implemented our CDS tool December 12, 2019. As of mid-June, 2020 a total of 1637 treatment plans have been implemented. Of those, 1323 (81%) are Tier 1A, 310 (2%) are Tier 1B and 4 (.2%) are Tier 2. Thus demonstrating 81% adherence to NCCN approved regimens across the system, regardless of the line of treatment. GI and breast cancers were responsible for the most plans with the highest adherence to Tier 1A plans, specifically 92% among the breast cancer group. Multiple Myeloma and Sarcoma were tied for the lowest adherence rate of 58%. This data can be further stratified by medical oncologist. Interestingly, Multiple Myeloma had the highest utilization of Tier 1B protocols perhaps reflecting the rapidly changing literature that is ahead of the guidelines. Conclusions: We demonstrated adherence to NCCN protocols 81% of the time over a 6 month period and over multiple cancer types. Protocol tagging and reporting utilizing the EMR alone could be used as a powerful model for value based care. We identified disease areas that will require further education regarding evidence based treatment and can consider interventions including real time feedback to clinicians and/or best practice advisories or quality based incentives.
A provider-focused, point-of-care technology to improve clinical trial accrual.
Authors: Anand Sidharth , Larson Sarah Marie , Fischer Katrina , Glaspy John A.
Published: October 2020

309

Background: Low accrual to clinical trials is a significant burden to advancing research efforts, particularly detrimental to patients who may benefit clinically from enrollment in a promising trial. Low accrual has been linked to a lack of provider awareness of clinical trials at the point of care and current technology solutions have not adequately addressed this important issue. Methods: We aimed to develop a system to improve clinical trial access for patients throughout UCLA Hematology-Oncology through the development of a point of care web-based tool to allow providers to easily identify available clinical trials for their patients. First, we built a comprehensive database of current clinical trials at UCLA, with special emphasis on streamlined exclusion/inclusion criteria. We incorporated this database into a front-end web and mobile-responsive tool with a user-friendly interface allowing users to rapidly identify patients eligible for clinical trial enrollment. We launched this tool 1/15/2019 to 56 oncologists at UCLA Health. Results: From 1/15/19 to 6/14/19 we had had a total of 713 unique logins to the clinical trials website. This included “academic oncologists,” those oncologists specializing in a particular disease sub-type and often a ‘hub’ for clinical trials, with an average of 6.4 logins per oncologist, and “community oncologists” with an average of 18.8 logins per oncologist over that time frame. A brief survey of users who logged in over 4 times during that time revealed that on average, 4-5 additional patients per user were screened for clinical trials not previously identified. Conclusions: Clinical trial accrual can be enhanced through improved provider awareness of available trials at the point-of-care. A well-designed user interface with features to help facilitate provider navigation to available trials and quick inclusion and exclusion criteria were critical to the success of the tool. Although the web-based tool achieved its primary purpose in improving clinical trial awareness, its utility diminished over time due to the lack of real-time updates of trial data. Based on provider feedback, if the available trial data can be updated and maintained on a regular basis, this can be a valuable tool to improve clinical trial awareness and subsequently, accrual.