bluuebunny/crossref_metadata_2025 huggingface dataset:
Capture of common adverse events (AEs) by patient-reported outcome measures (PROMs) used in clinical trials of immuno-oncology (IO)-based combination therapies in advanced renal cell carcinoma (aRCC).
Authors: Huo Stephen , Ejzykowicz Flavia , Delgado Andrew , Beauchamp Karen D.
Published: September 2022

263

Background: IO-based combination therapies have improved clinical outcomes in aRCC; several are approved for first-line use. AEs can significantly impact quality of life, and IO therapy is associated with AEs that differ from prior standard treatment toxicities. PROMs capture health status directly from patients and often include the symptoms and severity of AEs. Our aim was to assess the extent to which the PROMs used in pivotal trials covered the most common AEs associated with IO combinations. Methods: This was a review of data from four phase 3, randomized, open-label studies of IO-based combinations in previously untreated advanced/metastatic clear-cell RCC (CheckMate 214, CheckMate 9ER, KEYNOTE-426, CLEAR [KEYNOTE-581]). The 10 most common all-grade, all-cause AEs (%) and the PROMs used in each trial were identified. The inclusion of the most common AEs in the PROMs was explored descriptively. Results: The most common AEs and their frequencies varied among the different combination regimens. There was also variation across trials in the PROMs used. Capture of the most common AEs by the PROMs used in each study is summarized in the Table. Conclusions: Current PROMs used in clinical trials of IO combinations for aRCC tend to capture more of the common AEs for IO-IO vs IO-tyrosine kinase inhibitor regimens. PROMs that reflect the unique AE profiles of IO therapies, especially from the patient perspective, may be needed for future trials.[Table: see text]
Building a SW program in a private hem/onc practice: Using the PHQ-9 as a starting point.
Authors: Marcus Neshama L , Woerner Shannon , Canavan Jake , Rattanaudom Kanokrose , Papandrea John , Ronnen Ellen A.
Published: September 2022

266

Background: Hematology/oncology patients historically have high need for social work support. Community practices lack the structure and financial support of hospital practices, often hindering the growth of social work programs. PHQ-9 is a 9-question multipurpose tool for depression screening, diagnosing, monitoring and intervening. This project assessed using the PHQ-9 as a central focus to build a SW program: staff education, EHR automaticity improvement, and enhancement of patient navigation to improve PHQ-9 compliance and patient interventions. Methods: In a multi-office Hem/Onc practice, patients complete the PHQ-9 self-assessment tool, data is entered by MAs, and MD completes an action item according to score. Interventions, which began 1/1/22, included having patients complete the PHQ-9 via a PRO application before visit, interfacing of PRO application with EHR (MA adds score to treatment plan), educating MAs importance of mental health monitoring in health care setting, generating new workflow for MA to send EHR message to SW and notify MD if high score obtained, rapid cycle review of data with MDs, and building out of SW department to accept referrals. Our primary endpoint was % of PHQ-9s completed of those scheduled (every six months). Secondary endpoint was total number of patients internally referred for SW services since 4/1/22 (when psychotherapy services became available). Results: From 7/1/21-12/31/21 (before implementation), of 22,492 visits, 72% had a PHQ-9 reported (with no ongoing monitoring or intervention). From 1/1/22-5/31/22, 88% of 18,655 visits had a PHQ-9 reported. 1,114 patients had a score of 10 or greater on the PHQ-9 between 1/1/22-5/31/22, and of those patients, 100% were assessed for social work intervention. 724 patients were offered referral for mental health services externally; 390 patients have been recommended for internal SW referral (72 have registered for psychotherapy to begin 7/1/22). Conclusions: Our results illustrate the ability to achieve engagement of a SW program in a private practice setting over a limited time by using the PHQ-9 as a primary focus. Education of all staff involved in the process is paramount and will be emphasized when rolling out future components of the SW program: support groups, educational lecture series, and other concrete services.
Trajectory of symptoms reported in remote symptom monitoring over the course of oncology treatment for gynecologic cancers.
Authors: McGowen Chelsea L. , Caston Nicole E. , McElhany Sheila K. , Diaz Bryanna E. , McNair Carrie C. , Franks Jeffrey , Andrews Courtney J. , Huang Chao-Hui , Dionne-Odom James Nicholas , Weiner Bryan J , Jackson Bradford E. , Basch Ethan , Stover Angela M. , Howell Doris , Rocque Gabrielle Betty , Young Pierce Jennifer
Published: September 2022

270

Background: Patients now have the ability to utilize electronic patient reported outcomes (ePROs) for remote symptom monitoring (RSM). This analysis seeks to better understand trajectory of reported symptoms during treatment for patients with gynecologic cancer participating in RSM. Methods: We approached patients with gynecological cancer initiating treatment at the Mitchell Cancer Institute (MCI) between 7/1/21-4/30/2022. Patients were eligible if they were starting chemotherapy, targeted therapy, or immunotherapy for a new cancer. Patients seeking a second opinion were excluded. Enrolled patients received symptom survey (PRO-CTCAE questions) via text or email once per week. Initially, only severe alerts were forwarded to the clinical care team; moderate alerts were forwarded to clinical teams once they were comfortable with alert management. Patients completed symptom assessments for 24 weeks or until withdrawal. Patient age at enrollment, race, sex, cancer type, cancer stage, and PROs were abstracted from electronic health records and the PRO platform (Carevive). Descriptive statistics were calculated using frequencies and percentages for categorical variables and median and interquartile ranges (IQR) for continuous variables. Results: A total of 60 female patients with gynecological cancer were enrolled; 33% were Black or African American and 67% were White; median age was 61 years (IQR 53-68). Seventy-eight percent (47/60) of patients reported 379 symptoms with at least one moderate or severe alert during this time period; 32% considered moderate and 68% considered severe. Overall, the most frequently reported symptom was pain (29%). At baseline (week 0), 14% and 41% of 56 patients reported moderate symptoms and severe symptoms, respectively. Symptom burden decreased over time with 4% and 7% of 27 patients who completed a survey at 12 weeks reporting moderate and severe symptoms. Specific symptom trajectories followed similar patterns. Conclusions: In our sample, patients reported the majority of symptoms during the first three months of treatment. Symptom trajectory decreased with time, suggesting symptoms are being effectively monitored and addressed by the clinical teams engaging in RSM. Future research is needed to understand if symptom improvement translates to increased quality of life, decreased hospitalizations, and increased survival for patients, as well as lessen the burden of call volume on the clinical team.
Improving patient satisfaction and care delivery for female veteran patients with cancer receiving outpatient infusion therapies.
Authors: West Malinda T , Tamba Gagah , Thawani Rajat , Drew Antonene , Cheng Rose , Wilde Nicole V , Graff Julie N , Mannino Rosemarie
Published: September 2022

279

Background: Our objective was to explore if differences in patient satisfaction based on gender exist in a Veterans Health Administration (VHA) outpatient chemotherapy infusion unit. Methods: Veterans who received outpatient infusion treatments from 2018 to 2020 were contacted by phone and agreed to partake in an anonymous 25 question online survey. Response differences were analyzed using Fisher’s exact and Welch's t-tests. Results: 69 veterans were contacted. 70% (21/30) of women and 51% (20/39) of male veterans completed the survey. Most women were < 65 years (62%), and 52% treated for breast cancer. 90% of men were > 65 years old, majority treated for prostate cancer (20%) or a hematological cancer (20%). Using our survey, patient satisfaction was 8.71/10 points (± 0.60) in women vs. 9.55 (± 2.24) in men (p = 0.113). 86% of women endorsed hx of sexual abuse or harassment vs 10% of men (p < 0.001). More women vs men felt uncomfortable around other patients and unable to voice uncomfortable experiences to a provider in the infusion unit (p < 0.05). Not statistically significant but potential clinical importance was more women felt uncomfortable around the offending gender (29% vs 0%), more women felt greater emotional support and importance with access to a tx room with the same gender (29% vs 0%), and more women preferred access to a gender specific restroom (30% vs 20%). Conclusions: Gender appears related to how veterans with cancer perceive their ambulatory cancer care. This may be due to the combination of high sexual abuse and/or harassment hx amongst women who are a minority of the total infusion unit population, the majority of whom receive tx for a primarily gender specific breast malignancy. Analysis was limited by the small sample size of women, many with advanced malignancy. Ongoing initiatives based on these survey results are underway and may be applicable to other outpatient cancer center facilities where patient demographic and infusion unit design may be similar.[Table: see text]
An assessment of patient-provider communication surrounding tumor genetic profiling in thoracic oncology.
Authors: Josowitz Julia , Roy Mohana , Larsen Rhonda
Published: September 2022

285

Background: Thoracic oncologists regularly order mutational testing for lung cancer, called the Stanford Actionable Mutation Panel (STAMP) at the Stanford Cancer Center, that assesses for somatic tumor based mutational testing. This project surveyed patients who had this testing and assessed their understanding of the test’s purpose and results in thoracic oncology. We also gathered information about which providers on the care team are conducting this counseling and time spent on patient education. Methods: This quality assurance project was deemed exempt from IRB review. We obtained an EHR query of patients who had the STAMP testing between July 2020 and July 2021, which was kept in a password protected file in a secured shared folder. Patients were contacted by phone using Doximity Dialer and answers were recorded in Redcap as the questionnaire was administered over the phone. Patient responses were labeled using a random number generator and no protected patient information was recorded. Results: The EHR query of patients who had the STAMP test performed in the last year resulted in 77 unique patients and 34 patients agreed to complete the survey. The majority of respondents (73.5%) knew that their physician or oncologist had ordered the STAMP test for them. Of those patients, the majority (84%) stated that their provider, most commonly their oncologist, explained the purpose of the test. The majority of respondents (64%) stated that their provider, most commonly their oncologist, had discussed the test results with them, which usually took approximately 5-10 minutes. Almost all respondents (93.8%) felt that they had time to ask the questions they had regarding their results. 43.8% of respondents stated that their test results changed their treatment options and 18.8% were unsure. Similarly, 43.8% of respondents stated that they had a targetable mutation, while 25% were unsure. Overall, 42.9% of respondents felt confident in their understanding of their test results, 33.3% were very confident, 4.8% felt neutral, and 19% were not confident in their understanding. Conclusions: In this single center survey, thoracic oncology teams appear to be communicating effectively with their patients about the purpose and results of molecular testing. However, patients were more uncertain about how the test influenced their treatment, identifying a potential area of improvement in patient education.
Is patient experience of care associated with treatment choices for women with early-stage breast cancer?
Authors: Halpern Michael T. , McNeel Timothy S. , Kozono David E. , Mollica Michelle
Published: September 2022

289

Background: For women diagnosed with early stage breast cancer, lumpectomy followed by radiation therapy is a guideline-recommended treatment. However, lumpectomy followed by hormonal therapy is also an approved treatment regimen for certain women. It is unclear what patient-driven factors are related to the decision to receive radiation therapy. This study examined the relationship between patient-reported experience of care, an important dimension of health care quality, and receipt of radiation therapy following lumpectomy among women with breast cancer. Methods: We used the SEER-CAHPS data resource (NCI Surveillance Epidemiology and End Results [SEER] data linked to Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey responses) to examine experiences of care among women diagnosed with local or regional stage breast cancer in 2000-2017 who received lumpectomy, were enrolled in fee-for-service Medicare, completed a CAHPS survey within 18 months of diagnosis, and survived for this study period. Experience of care was assessed by patient-provided numeric scores for overall care, health plan, physicians, customer service, doctor communication, care coordination, and other aspects of care. Multivariable logistic regression models assessed associations of receipt of radiation therapy with care experience and patient sociodemographic and clinical characteristics. Results: The study population included 825 women; 651 (79%) received radiation therapy. Approx. 84% were diagnosed with localized (vs. regional) breast cancer. Women with higher experience scores for their personal doctor or for care coordination were significantly more likely to have received any radiation therapy. In contrast, among women enrolled in Medicare Part D plans, those who reported higher scores for their prescription drug plan were significantly less likely to have received radiation therapy. Conclusions: Patient experience of care was significantly associated with receipt of radiation therapy following lumpectomy among women with breast cancer. While these results do not show causality, future quality improvement initiatives may want to explore the role of patient experience of care in facilitating patient decision making and improving quality of care.
Gastrostomy, tracheostomy, opioid, and health care utilization among patients with recurrent/metastatic head and neck cancer receiving immunotherapy.
Authors: Uy Natalie F. , Ng Kevin , Voutsinas Jenna M. , Wu Vicky , Futran Neal D. , Houlton Jeffrey , Barber Brittany , Laramore George E. , Parvathaneni Upendra , Liao Jay Justin , Rodriguez Cristina P.
Published: September 2022

296

Background: Immune checkpoint inhibitors (ICI) are approved for recurrent and/or metastatic squamous head and neck cancers (R/M HNSCC). Landmark trials have shown stable or improved patient (pt) reported quality of life outcomes. It is unclear how these translate into gastrostomy (G) and tracheostomy (T) dependence, opioid use, or ER/unplanned hospitalizations (UH) in an unselected population. We sought to explore these in our large single institution cohort. Methods: We reviewed R/M HNSCC pts receiving ICI at a tertiary referral NCI designated cancer center. Outcomes were assessed between the first dose of ICI and 100 days after the last dose of ICI. Overall survival (OS) was estimated via Kaplan-Meier estimation. Differences between groups were assessed via log-rank testing procedure and adjusted for age, tumor characteristics, and smoking status. Results: Between 1/2012 and 12/2019, we treated 152 pts with ICI, mostly male (n = 142, 82%), partnered/married (n = 103, 68%), with median age 64 years (range 23 – 90). The most common primary sites were oropharynx (n = 55, 36%) and oral cavity (n = 33, 22%). 50 (35%) had ≥2 lines of prior systemic therapy and 29 (19%) had an ECOG ≥2. The most common pt races were white (n = 114, 75%), Asian (n = 14, 9%), and Hispanic, any race (n = 6, 4%). 83 (55%) and 23 (15%) had history of smoking and heavy alcohol use respectively. Median duration of ICI therapy was 95 days (range 1-1720). Prior to ICI, 49 (32%) had G, 17 (11%) had T, and 15 (10%) had both. While on ICI, 6 (4%) had G placed, and 1 (1%) had a G removed; 1 (1%) had T placed, and 2 (1%) had T removed. 69 (45%) had ER visits and 57 (38%) had UH; 11 (7%) were directly related to ICI adverse effects. Prior to ICI, 104 (68%) were on opiates; requirements increased in 58 (41%) pts and decreased in 17 (12%) pts. Pre-existing G prior to ICI had worse OS on log-rank testing, but significance was lost when adjusted for variables. Pre-existing T prior to ICI (p = 0.001, HR 3.08, 95% Cl [1.56,6.08]), and pts with increasing opiate requirements on ICI (p value = 0.0007, HR 2.13, 95% Cl [1.38,3.28]) had worse OS. Conclusions: In our cohort, ICI did not change G or T usage. Pre-existing T and increasing opiate use were also associated with worse survival. Our data supports augmentation of palliative care and advanced care planning in the R/M HNSCC population.
Quality initiative (QI) to improve molecular testing in newly diagnosed (ND) stage 4 non-small cell lung cancer (NSCLC-4): An Integra Connect (IC) database study.
Authors: Smith Robert E. , Gart Mike , Choksi Rushir J. , Petro Daniel P. , Scott Jeffrey A. , Varughese Prateesh , Stockton Matt
Published: September 2022

304

Background: In August 2019 IC partnered with University of Pittsburg Medical Center (UPMC) on a QI aimed at improving outcomes in stages 3 and 4 NSCLC. This report details the findings, interventions, and results in the stage 4 cohort to date. Guidelines advocate broad molecular profiling and completion of biomarker testing prior to initiation of initial therapy (KF Mileham,2022). However, real world data has shown a high rate of treatment initiation without biomarker testing due to low rate of testing and, if tested, treatment prior to results reporting (H West,2021; J Nicholas, 2021) in this disease state having a 5-year survival of only 7% (N Howlander). Based on analysis of the US Oncology Network it was found that only 46% of patients (pts) with metastatic NSCLC received testing for PD-L1, EGFR, ALK, ROS1, and BRAF-V600E (J Nicholas, 2021). Methods: By querying the UPMC and IC databases, 910 patients (pts) with ND NSCLC-4 were identified who received an initial line of therapy, excluding squamous carcinoma pts unless documented never-smokers, during 1/1/2017- 12/31/2021. Date of EGFR test ordered, date of test result report to electronic health record, and date of treatment initiation were captured. Also included were test orders for the NCCN recommended biomarker panel of PD-L1, ALK, ROS1, BRAF, RET, MET, and NTRK. The data were evaluated in three time periods for the QI: Phase 1 of 1339 days (1/1/2017-8/31/2020) for baseline, Phase 2 of 122 days (9/1/2020-12/31/20) post physician leadership intervention, and Phase 3 of 516 days (1/1/2021-5/31/2022) performance measurement period. Baseline and on-going measurement of testing metrics was performed with physician leadership intervention for identified gaps in care. Additionally, surveys were implemented to assess caregiver perceptions. The use of chart curation and software-based monitoring tools powered by IC enabled providers to understand current levels of testing and track performance over time. Results: Median age was 68 (range 36 - 89) and 49% male. As shown in Data Table, EGFR testing at baseline was 94% and increased to 98%. Testing of the entire biomarker panel noted above increased from 52% baseline to 70% at this point in Phase 3. While only 72% had treatment initiated after EGFR result at baseline, this improved to 83% during Phase 3. Conclusions: This QI led to improvement in rates of broad biomarker testing and initiation of treatment only after results were made available in this NSCLC-4 population. While this initiative was not designed to evaluate outcomes, one would expect outcome improvement over baseline with higher guideline adherence.[Table: see text]
Improving performance status documentation using an electronic medical record tool.
Authors: Emmich Megan , Holle Lisa
Published: September 2022

309

Background: Performance status (PS) is used regularly in oncology care to select appropriate cancer treatment, track changes in level of functioning, and determine clinical trial eligibility. In addition, the American Society of Clinical Oncology (ASCO)/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards requires that on each clinical encounter, staff performs and documents a patient assessment that includes 8 elements; one of which is PS. Currently, little instruction is provided on how to utilize and record a more standardized criteria, such as PS with either ECOG or Karnofsky scores, in the electronic medical record (EMR) which results in suboptimal documentation. We assessed documentation of PS before and after implementation of a tool within the EMR at our outpatient cancer center. Methods: Using the Plan-Do-Study-Act (PDSA) technique, a quality improvement project was developed to determine if our center was consistent with the ASCO/ONS guidelines. An EMR tool was developed that enabled clinicians to standardize PS documentation within an encounter via population of a flowsheet to improve compliance. Clinicians were educated on guidelines and utilization of the PS tool and data was collected pre- and post- implementation. A survey was developed and administered to assess PS tool use and to learn of any barriers to implementation. Based on survey results, we created a reminder tip sheet for clinicians to utilize the PS tool; a subsequent chart review was completed. Results: In a random pre-study 50 chart review, 0% of encounters in our lung and breast clinic had PS documented. At the time of pre-tool implementation, due to the lack of a retrievable flowsheet, we did not obtain a reliable PS documentation percentage. After education and tool implementation, 2481 random encounters were evaluated of which 315 encounters (12.6%) documented PS and used the PS tool. A total of 7 (35%) clinicians completed the survey: 4 physicians and 3 advanced practice registered nurses. Of those who responded, 57% used the PS tool, 71% used a note template with ECOG PS embedded, and 85.7% were willing to alter their note template to incorporate ECOG PS. Barriers identified included: limited time, workflow constraints and redundant documentation. After tip sheet implementation, 66% of encounters documented PS; however, only 6 out of those 33 encounters (18%) documented PS using the PS EMR tool. Conclusions: Documentation support tools help facilitate care and enable measurement of guideline concordance, but once implemented it can be challenging to maintain adherence. Although this study improved overall PS documentation (0 to 66%), we were only able to demonstrate a 6% increase in the use of our PS documentation tool. While PS tool implementation was feasible, adoption of the additional tool was not universal. We aim to gather additional clinician input to improve PS documentation completion and guideline adherence.
Supporting high-risk oncology patients with an outpatient transitional care management program.
Authors: Bhattacharya Manisha , Graziano Regina , Wahal Evanne , Alexander Julie , O'Connor Lynne , Cumberledge Rene , East Avigayil , Zandberg Dan Paul , Thomas Roby Antony
Published: September 2022

313

Background: Transitional Care Management initiatives (TCM) financially support comprehensive outpatient followup in the first 30 days after acute care discharge. TCM programs require patient contact within 2 days of discharge, an outpatient appointment within 7-14 days, patient education, and moderate-high complexity medical decision-making that supports successful outpatient transition. To date, TCM is often utilized to provide additional reimbursement for qualifying primary care post-discharge followup, but could be applied to align incentives in busy oncology practices. We present a novel application of TCM to enhance post-discharge cancer care with the goal of reducing readmissions for high-risk oncology patients. Methods: We identified patients discharged from our health system’s cancer hospital with a “Highest” risk of readmission as determined by an internally developed machine learning clinical algorithm built into the EMR. Patients were targeted with a post-discharge phone call within 48 hours offering an in-person or telemedicine appointment within 72 hours. The Transitional Care Clinic (TCC) visit guidelines promote connection to ancillary services such as physical and occupational therapy, medication management, and dietetics. The TCC can offer interventions to address emergent medical needs such as fluids, transfusions, and symptom management. Results: In the first three months of the TCC program, the 30-day readmission risk algorithm identified 136 cancer patients discharged from the designated cancer hospital in the “Highest” readmission risk category. 121 of those patients were previously admitted within one year. 72 of the 136 “Highest” risk patients were referred to the cancer center TCC workflow and 60 patients were eligible for a TCC appointment. 18 patients had appointments scheduled (30%) with 83% completed (15/18). 22% of scheduled appointments were via telemedicine (4/18) and 100% of these appointments were completed. Conclusions: TCM programs can be adapted to reward timely hospital followup for oncology patients after discharge. TCM requirements overlap with several common elements of readmission reduction initiatives, but EMR tools for identifying patients at highest readmission risk may need additional adaptation into clinic workflows to promote a high capture rate that justifies program support. Future longitudinal cohort analysis will establish if the TCC is able to reduce cancer-related readmissions in high-risk populations.
Improving documentation of zoledronic acid interval in ambulatory oncology patients.
Authors: Dandawate Tanvi
Published: September 2022

323

Background: Therapy plan orders for certain repetitive medications such as Zoledronic Acid do not always reflect the interval administered. This creates a patient safety risk as patients may get extra or fewer doses than required, a lack of clarity for pharmacy dispensing and nurses administering the medication and delays for patients while the orders are corrected. In a 3-month period, 30 safety reports of Zoledronic Acid therapy plan discrepancies were reported. Methods: Baseline data was determined using manual chart review of a sample of 50 patients, reviewing documentation of Zoledronic Acid interval in four fields in the chart. 58% of patients had an incorrect interval in therapy plan title and 12% of charts had discrepancies in other fields. In initiating this improvement project, we identified and engaged key stakeholders (nurses, providers, IT, patient safety and pharmacists) in DFCI oncology outpatient areas in a series of interactive meetings to share baseline data and use quality improvement tools (process mapping and impact-effort matrix) to identify solutions. In PDSA cycle 1, the options of Zoledronic Acid therapy plans were modified from having separate plans for each interval to a single therapy plan with options to select the interval. This was done with the goal of reducing the number of fields with the interval to reduce discrepancies in interval. In PDSA cycle 2, a team of pharmacists reviewed charts of patients who had an appointment with a provider and were on Zoledronic acid weekly, for 12 weeks. Charts with interval discrepancies were sent to the ordering provider for correction. This was done for two disease groups over a period of 6 months. Results: Post the completion of PDSA cycle 1, an analysis of 7165 dispenses showed that Zoledronic Acid therapy plans containing information apart from medication name in title decreased from 90% in 2019 to 0.4% in 2021. PDSA cycle 2 addressed discrepancies in another 126 patient charts, reducing the overall discrepancies from 12% to 7%. Conclusions: This project demonstrates multidisciplinary approach to identifying solutions to discrepancies around Zoledronic Acid intervals in patient charts has reduced this patient safety risk. The solutions implemented in PDSA cycle 1 was a system-based solution with a high impact. PDSA cycle 2 helped mitigate the safety risk further. Additional system-based solutions are essential in the long term to reduce documentation variability and improve quality and safety of care for patients receiving Zoledronic Acid.
Claims-based cardiac monitoring (CM) in patients (Pts) receiving trastuzumab (TZ).
Authors: Bandini Lindsey , Denlinger Crystal S. , Duggan Goldstein Sarah Ford , Marinkovich Wendy , Edge Stephen B. , Carlson Robert W.
Published: September 2022

324

Background: TZ in HER2-positive breast cancer (BC) has established improved outcomes in certain Pts. TZ carries a black box warning and a recommendation for CM in all Pts prior to and during treatment (tx) Few studies have evaluated real-world CM compliance during tx. Methods: Retrospective, cross-sectional analysis was conducted to identify CM compliance among BC pts receiving TZ, using a limited data set of administrative claims data consisting of female Pts who were continuously insured over a 24-month period between Jan 1, 2019 and Dec 31, 2020, as provided through a secure portal by Blue Cross Blue Shield Association. [1] . BC diagnosis was confirmed by ICD-9 code, while tx with TZ or biosimilar was confirmed through Healthcare Common Procedure Coding System codes. A care episode spanned 14 months, including 123 days prior to first TZ dose (Index Date) and at least 307 days of follow up. Two cohorts (eligibility for both dx and continually insured status of female commercial Pts, 2018-2019 and 2019-2020) were analyzed across four tx Phases (Pre-Tx Phase [days -123-+ Index Date as day 1], Phase 1 [days 61-123], Phase 2 [days 153-215], Phase 3 [days 245-307]). Phase denominators were calculated independently, only including Pts with ongoing TZ tx for each Phase. [1] Blue Cross Blue Shield Association is an association of independent, locally operated Blue Cross and Blue Shield companies. Results: Pts in each Phase and cohort ranged from 2,304 (Full Compliance 2019-2020) to 3,263 (Pre-Tx 2019-2020). Similar results were seen in both cohorts, with highest proportion of Pts receiving CM in Pre-Tx phase. Overall compliance in Pre-Tx Phase and all subsequent Phases was low; nearly two-thirds of Pts missed one or more CM tests. Drop-off in CM testing occurred in each subsequent tx Phase (Table). Conclusions: Continued decline in CM over time suggests lack of awareness for potential late TZ cardiac toxicity. Further research regarding why Pts are not receiving recommended baseline and on-treatment CM is needed. Routine CM during TZ tx may be a quality indicator for practices, payers, and quality improvement programs.[Table: see text]
Increasing tobacco cessation counseling and referral in a statewide oncology collaborative.
Authors: Ruiz Martinez Mariem , Griggs Jennifer J. , Liu Manlan , DeVries Kelly
Published: September 2022

327

Background: Oncology providers are uniquely positioned to provide tobacco cessation interventions because the motivation to quit can increase at the time of a cancer diagnosis. Physician advice to quit smoking increases the likelihood of a quit attempt by 25%. The Michigan Oncology Quality Consortium (MOQC), a physician-led quality improvement consortium of nearly all oncology practices in Michigan, has made tobacco cessation counseling and referral a priority. Methods: The Michigan Oncology Quality Consortium (MOQC) began abstracting tobacco cessation counseling and referrals from oncology medical records into the Quality Improvement Practice Initiative (QOPI) platform of the American Society of Clinical Oncology (ASCO) beginning in 2014. MOQC has developed and disseminated effective resources to ensure that practices in the consortium have access to tobacco cessation services through a grant to the Michigan Department of Health and Human Services (MDHHS). In 2017, performance on this measure was selected as one of our value-based reimbursement (VBR) measures. We also compared our data with responses from the Behavioral Risk Factor Surveillance System (BRFSS) obtained through MDHHS in response to the following question: “Earlier you indicated that you currently smoke cigarettes. Has your doctor or other health professional ever advised you of, or referred you to, a program or other resources available to help you stop smoking?”. Results: Between 2015 and 2021, 6,048 patients were included in the measure denominator. In 2015, only 44% of patients had documented counseling or referral to tobacco cessation services. Performance on this measure has increased each year as shown in the table. Data from the BRFSS Michigan Department of Health and Human Services (MDHHS) also show year-over-year improvement in patient reports of having been advised to quit. Conclusions: Our statewide collaborative successfully increased the proportion of patients who smoke who were either counseled to quit smoking or who were referred to smoking cessation services. The decrease in performance in 2020 and 2021 was likely to be the result of the COVID-19 pandemic. The addition of the VBR may have contributed to the success of our program. Through a partnership with HBOM- Health Behavior Optimization for Michigan, MOQC will create additional measures to continue to incentivize practices to get back to pre-pandemic levels of tobacco cessation referrals.[Table: see text]
Modifiable risk factors for falls among older adults with advanced cancer.
Authors: Jensen-Battaglia Marielle , Mohamed Mostafa Refaat , Loh Kah Poh , Wells Megan , Tylock Rachael , Ramsdale Erika E. , Canin Beverly , Geer Jodi , O'Rourke Mark Allen , Liu Jijun , Mohile Supriya Gupta , Wildes Tanya Marya
Published: September 2022

328

Background: Older adults with cancer are more likely to fall than those without cancer, but the factors driving this increased risk are not fully understood. Falls may lead to injury, dependence, hospitalization, and death. Given the interventions available to reduce fall risk, identifying risk factors amenable to intervention for older adults with cancer is critical to provide targeted care and improve health outcomes. Methods: To examine factors associated with patient-reported falls within a 6 month follow up period, we analyzed data previously collected in a nationwide cluster randomized trial (ClinicalTrials.gov: NCT02107443; PI: Mohile, NCORP UG1CA189961). Patients were eligible if age ≥70, stage III/IV solid tumor or lymphoma with palliative treatment intent, and ≥1 geriatric assessment impairment (GA). A GA summary with tailored recommendations was given to oncologists in practices randomized to the intervention, but not usual care. We combined intervention and usual care groups and evaluated baseline risk factors for falls over a 6 month follow up including: prior falls, fear of falling (FOF), activity limitation due to FOF, activities of daily living, Short Physical Performance Battery, Timed Up and Go (TUG), Older Americans Resources Survey (physical health scale), cognition, polypharmacy, potentially inappropriate medications (PIM), and neurotoxic treatment agents. Incidence rate ratios (IRR) were estimated using generalized linear mixed models controlling for the study arm and practice site. Fully adjusted multivariable models were built for factors associated with follow up falls (p≤0.15) in bivariate. Results: Of 541 patients (mean age: 77, SD: 5.27), 140 (26%) patients had prior falls in the past 6 months. Over 6 months of follow up 467 (86%) had falls data for ≥ 1 follow up timepoint and 344 (64%) had complete follow up. Of those contributing any follow up data 103 patients (22%) reported at least one fall. In adjusted models prior falls, impaired TUG, and number of PIM were associated with higher incidence of falls over 6 months (see Table). Conclusions: Prior falls, TUG, and PIM are prospectively associated with falls among older adults with advanced cancer. These factors are feasible to assess and amenable to interventions such as rehabilitation or deprescribing. Future studies focused on implementation of fall risk reduction in the oncology setting are needed to determine the most effective ways to reduce fall risk in this vulnerable population. Clinical trial information: NCT02107443. [Table: see text]
What is the prognostic value of lymph node yield on the outcomes of patients with oral cavity squamous cell carcinoma?
Authors: Khalil Carlos , Khoury Mark , Fu Rui , Enepekides Danny , Higgins Kevin , Karam Irene , Bayley Andrew , Poon Ian , Truong Tra , Husain Zain Ali , Eskander Antoine
Published: September 2022

330

Background: Lymph node metastases are associated with poor prognosis in oral cavity squamous cell carcinoma (OCSCC). In colorectal, lung, and gastric cancers, the number of lymph nodes removed during primary surgery, lymph node yield (LNY), is an established quality indicator that links with patient survival. As such, clinical guidelines have included a minimum (18) number of nodes to be resected, despite a lack of statistical evidence that supports such a LNY threshold. Currently, this kind of recommendation does not exist for OCSCC. Here, we used a novel single-centre dataset to evaluate the prognostic capacity of LNY on regional failure, locoregional recurrence and disease-free survival (DFS) in patients with OCSCC treated by primary neck surgery. Methods: This retrospective cohort study took place at Sunnybrook Hospital in Toronto, Canada and involved chart review data of all adult patients with treatment-naive OCSCC undergoing primary neck dissection. For each outcome, we first used the maximally selected rank statistics and a bias-corrected C-index to identify an optimal threshold of LNY, and then used a multivariable Cox proportional hazards model to assess the association between high LNY (> threshold) and each outcome. Results: Among the 579 OCSCC patients receiving primary neck dissection, 61.7% (n = 357) were male with mean age of 62.9 years (SD: 13.1) at cancer diagnosis. When adjusting for sociodemographic and clinical factors, LNY > 15 was significantly associated with improved DFS (adjusted HR [aHR]: 0.73, 95% CI: 0.54-0.98) and locoregional control (aHR: 0.68, 95% CI: 0.49-0.95), while LNY > 11 was associated with better regional control (aHR: 0.45, 95% CI: 0.26-0.76). Conclusions: Our study findings suggested high LNY to be a strong independent predictor of various patient-level quality of surgical care metrics. The optimal LNY we found (15 or 11) was lower than the conventionally recommended (18), which calls for further research to establish the validity in practice.
Family history screening following new diagnoses of leukemia versus solid malignancies.
Authors: Bleiberg Benjamin Aaron , Steinkamp Jackson , Jordan Bruno Ximena
Published: September 2022

333

Background: Family history screening for malignancies informs the need for genetic testing of cancer patients and their families. Associations between heritable mutations and solid malignancies are well-established, but germline contributions to hematologic malignancies may be of similar importance. For instance, the pooled risk of a group of heritable transcription factor mutations including RUNX1, GATA2, and CEBPA may play a role in up to 15% of new cases of leukemia. Standard of care for new patient visits in malignant hematology clinics should involve thorough family screening like that of solid malignancies more classically associated with heredity. Methods: All patients presenting to an academic hospital system's outpatient GI, breast, and leukemia clinics for new patient visits in a 3-month period were identified accounting for 706 participants (breast n=258 (36.5%), GI n=303 (42.9%), leukemia n=145 (20.5%)). Retrospective chart review was completed by EMR report, which aggregated data from individuals identified by their cancer diagnosis. Groups were compared along the following variables: percentage with completed 1st degree (parents and siblings) family history of malignancy screening, percentage with completed 2nd degree (grandparents, aunts, and uncles) family history screening. Chi-squared significance testing was completed to identify significant (p<0.05) differences in screening, which was considered completed if entered in the searchable summary information of the patient’s chart. Results: Patients presenting for new patient visits in breast (77.1%) cancer clinic had significantly higher rates of 1st degree family history of malignancy screening than those presenting with new diagnoses of leukemia (62.1%). The comparison of 1st degree screening for GI (71.6%) cancer patients and leukemia patients was not significant. Rates of 2nd degree family history screening were significantly higher for patients with new diagnoses of breast (61.6%) and GI (37.0%) cancers as compared to those with leukemia (24.8%). The combined cohort of GI and breast cancer patients had significantly greater rates of 1st (74.2%) and 2nd degree (48.4%) family history screening than patients with new diagnosis of leukemia. Conclusions: There is growing appreciation of heritable germline contributors to leukemia pathogenesis. However, there remains a deficit in clearly documented, easily referenced family history screening for malignancies in patients with new diagnoses of leukemia when compared to patients with new diagnoses of classically heritable solid malignancies.[Table: see text]
Leveraging continuing education and implementation science approaches to improve the care of patients with myeloproliferative neoplasms.
Authors: Kim Joseph , Mesa Ruben A. , Carter Cody , Nguyen Anthony Loc , Lau Eric , Sheth Parthiv , Dalal Suhani , Behl Rajesh , Gutman Pablo , Gracie-King Linda , Viens Marc David , Ocana Victor
Published: September 2022

334

Background: Myeloproliferative neoplasms (MPN) represent a heterogenous group of disorders associated with complicated symptom profiles and a propensity for disease transformation that may portend poor prognosis. Clinicians treating patients with MPN may improve treatment planning, disease monitoring, and care coordination by ensuring they check for driver mutations, assess and document symptoms, and evaluate prognostic factors. MPN is relatively uncommon, so clinicians may forget to apply these practices. Blending continuing education with implementation science approaches may help clinicians provide consistent, high-quality care for patients with MPN. This project was supported by an educational grant from Bristol Myers Squibb. Methods: Three hospital-based cancer centers participated in this 18-month longitudinal, multiphase CME/CE and QI initiative. Each hospital performed a baseline assessment by reviewing how their clinicians diagnosed and treated MPN. This process involved chart reviews (N = 38), focus group discussions, and online surveys. Clinicians also participated in two CE interventions and identified ways to implement practice changes that would lead to better care. Each hospital developed improvement projects that addressed one or more of the following: molecular diagnostics, symptom assessment and documentation, prognostic scoring, and treatment selection/planning. Clinicians assessed the feasibility of ideas such as reflex testing protocols, scheduled audit/feedback, patient registries, and clinical documentation shortcuts (eg, SmartText/Phrases).Results: As a result of the CE activities combined with the QI projects, the following competency-based educational outcomes were observed among clinicians: 40% increase (29.6% to 70%) regarding prognostic risk stratification; 41% increase (25.9% to 66.7%) in personalizing treatment plans based on disease-/patient-specific factors; and 24% increase (47.4% to 71.4%) in prioritizing goals of treatment. Based on patient chart data, the QI projects resulted in 15.8% increase (84.2% to 100%) in patients with MPN receiving molecular testing (eg, JAK2, CALR, and MPL genes); 66.7% increase (0% to 66.7%) in patients with MPN who have a documented symptom burden score based on a validated tool (eg, MPN-10); 24.1% increase (34.2% to 58.3%) in patients with MPN who have a documented prognostic score (eg, DIPSS); and 38.8% increase (22.7% to 61.5%) in eligible patients with MPN who are treated with JAK inhibitors. Conclusions: This project demonstrates how multiphase education and QI methods can help clinicians improve care for patients with MPN. Implementation strategies that triggered appropriate reminders and facilitated clinical documentation were considered most useful and sustainable for routine clinical practice.
Nationwide implementation of a multifaceted, tailored strategy to improve uptake of standardized structured reporting in oncological pathology: An effect and process evaluation.
Authors: Swillens Julie , Voorham Quirinus , Akkermans Reinier P. , Nagtegaal Iris D. , Hermens Rosella
Published: September 2022

336

Background: Implementation strategies improve guideline adherence. Effect and process evaluations are conducted to provide insights into success or failure of implementation strategies. We conducted both evaluations to determine nationwide implementation of standardized structured reporting (SSR) in pathology, to facilitate optimal treatment decisions in oncology care. Methods: We conducted an interrupted time series analysis to evaluate the effect of a fully digital nationwide implementation strategy on SSR use in pathology laboratories. We further conducted a process evaluation to evaluate the exposure to the strategy elements, the experiences of the users with the implementation strategy and remaining barriers of SSR implementation. We also tested whether being exposed to a specific element of the strategy resulted in more increase of average SSR use. Results: There was a significant increase in average SSR use directly after the strategy introduction for reporting of gastrointestinal ( p =.018) and urological ( p =.003) oncological diagnoses. A significant increase was present for all oncological resections as a group ( p =.007). The “Feedback button”, an option within the templates used for standardized structured reporting to provide feedback to the provider and one of the elements of the implementation strategy, was most frequently used by the SSR users and effectiveness results showed that it increased average SSR use after strategy introduction. Remaining barriers most related to rigidity, time consumption and content of SSR. Conclusions: Nationwide SSR implementation improved for specific tumor types and retrieval methods. Next step will be to further improve the use of SSR, and simultaneously, to further develop potential benefits of high SSR use, focusing on re-using discrete pathology data. In this way, we can eventually facilitate proper treatment decisions in oncology.