bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient-centered communication: Collaborative learning and communication strategies for patient and healthcare providers in the new normal of COVID-19.
Authors: Raymond Martha Ann , Simonetta Margaret-Ann 
Published: October 2020

152 Background: Data from the National Cancer Institute’s Surveillance, Epidemiology & End Results (SEER) program estimates in 2020 over 1.8 million new cancer diagnoses will occur. SEER data also indicates that over 15.5 million patients/survivors are currently living with a cancer diagnosis in the United States. Amid COVID-19, transitioning care beyond the clinic to minimize exposure for patients and healthcare providers is essential. Now more than ever, new and evolving ways to communicate openly and effectively are crucial for patients and their healthcare team. Methods: March-May 2020 the Raymond Foundation hosted nationwide virtual focus groups and town halls for cancer patients, survivors, and caregivers to gain a better understanding of how COVID-19 is affecting their cancer care, communication with their healthcare team, and shared decision-making. Primary goals included reaching patients in rural, urban, and community oncology settings to gain perspective from diverse populations. Results: 489 patients, survivors, and caregivers (54% female, 46% male) provided the following insights: 89% reported communication with their healthcare team had deteriorated since the pandemic; 94% indicated the need for increased communication with their healthcare team; 42% had a general knowledge of telehealth while 58% had little to no knowledge; 98% indicated they would like to learn more about telehealth options and would try this advanced class of service if offered by their healthcare team; 64% reported they were not able to accurately communicate treatment adverse effects leading to increased suffering; 96% reported increased isolation and fear of the unknown care landscape. Conclusions: Cancer patients realize the importance of patient-centered communication to facilitate a personalized dialogue to actively participate in their care. Empowering patients with the skills they require to comprehensively perceive telemedicine, virtual care, and remote monitoring will help minimize patient risk and provide an opportunity for patients to engage with their healthcare team throughout the care continuum. Implementing strategies to skillfully serve patients via telemedicine and teleconferencing may be the new normal as we virtually revive the classic house call.
Baseline cancer worry and tumor marker testing among earlier-stage breast cancer patients participating in a Choosing Wisely pilot.
Authors: Kreizenbeck Karma L. , Egan Kathryn , Wong Tracy , Jagels Barbara , Jensen Barbara , Smith Julie C. , Irwin Blair Billings , Noble Heather , Ramsey Scott David 
Published: October 2020

153 Background: We developed a patient-facing video aimed at raising early breast cancer survivors’ adherence to ASCO’s Choosing Wisely recommendation against surveillance tumor marker testing. To understand the impact of the video on cancer worry regarding recurrence, we surveyed breast cancer survivors before and after viewing the video. Methods: Women with stage I-IIIA breast cancer (N=246) treated at six regional community clinics were surveyed prior to viewing a video at the start of surveillance, then again at follow-up one year later (N=171). Both surveys included the Cancer Worry Scale (CWS-8 items, 4-point Likert scale). Tumor marker (TM) testing during surveillance was collected for 728 patients and linked to surveys among those who provided consent (N=105). Results: Most women (77%) were white age 50+. Among women who completed both questionnaires (N=153), the average CWS summary score was 17.1 at baseline (range=9-29) and 16.9 at follow-up ( p=0.48, range=8-30). Women who did not view the video (A) and those with high baseline cancer worry (B) who viewed the video had similar rates of TM testing (19%) compared to patients with low baseline cancer worry (C) who viewed the video (3%). Cancer worry is highly correlated with the decision to use of TM testing. Viewing an informational video that provided evidence-based advice on follow-up and testing did not impact cancer worry. Enrollment among eligible patients was impacted by challenges to proactively identify and consent patients during their transition to surveillance. Conclusions: Patients with high baseline cancer worry may need different or additional guidance beyond an educational video during their transition to surveillance for breast cancer. [Table: see text]
Leveraging patient-reported outcomes (PROs) in patients with pancreatic cancer: The Pancreatic Cancer Action Network (PanCAN) online patient registry experience.
Authors: Gupta Arjun , Khalid Omar , Ladnier Dennis , Moravek Cassadie , Lamkin Anica , Matrisian Lynn McCormick , Doss Sudheer , Denlinger Crystal S. , Coveler Andrew L. , Weekes Colin D. , Roeland Eric , Hendifar Andrew Eugene , Nipp Ryan David 
Published: October 2020

154 Background: By allowing patients (pts) to self-report key issues related to their quality of life and symptoms, PROs have important clinical and research implications. The PanCAN Registry, which began collecting data in July 2015, is a pancreatic cancer-specific global online registry enabling pts to report sociodemographics, disease/management characteristics, and PROs via online surveys. We sought to describe pt experiences with the PanCAN Registry. Methods: We assessed individual characteristics and interactions with the registry (visits, survey completions, and longitudinal use) from 7/2015-10/2019 for pts who provided permission to use their data. The registry allows pts to complete surveys about their experience (e.g. basics of pancreatic cancer, general information), symptoms (e.g. fatigue, pain), diagnostics (e.g. labs, scans), and drug therapy (e.g. type, frequency). We validated PROs using the PanCAN Know Your Tumor database. For a subset of pts (those with de novo metastatic disease), we compared PROs, treatment patterns, and side effects by age (+/- 65 years) and treatment site (community or academic). Results: Of 2,836 pts who visited the registry, 2,076 (73%) completed at least one survey (median age = 64 [range: 18-97], 48% women, 92% white, 32% metastatic disease). Pts most commonly completed the basics (73%), general information (39%), and drug therapy (37%) surveys. Overall, 10% answered surveys longitudinally. We observed 95% concordance between PROs and the PanCAN Know Your Tumor database. Among the 667 pts with de novo metastatic disease, 34% were older (age 65+) and 50% were treated at academic sites. Younger pts were more hopeful about the treatment plan (strongly agree: 24% v 12%, p < .01) and reported less constipation (moderate/severe: 33% v 48%, p < .01) compared with older pts. Pts treated at academic sites reported less frequent treatment breaks of > 2 weeks (28% v 58%, p = 0.01) and more frequent severe cytopenias (27% v 12%, p = 0.01) compared with those treated at community sites. Conclusions: With > 2,800 pts visiting the PanCAN registry and > 70% completing a survey, these findings demonstrate the feasibility, robustness, and research potential of an online PRO registry. We observed important differences by age and treatment site regarding pts’ outlook, symptoms, treatment patterns, and side effects. With increasing focus on PROs, registries like this can facilitate standardized PRO reporting and monitoring, while also providing a valuable research database.
Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T-cell therapy: Qualitative analyses of pretreatment patient interviews in the KarMMa trial.
Authors: Braverman Julia , Moshkovich Olga , Miera Matthew , Shah Selam , Brion Triza , Devlen Jennifer , Hege Kristen , Campbell Timothy Brandon 
Published: October 2020

155 Background: Outcomes remain poor in triple-class exposed (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody) patients (pts) with relapsed and refractory multiple myeloma (RRMM), and there is no standard of care. Ide-cel, a BCMA-directed CAR T cell therapy, showed deep, durable responses in heavily pretreated RRMM pts in the pivotal phase 2 KarMMa trial ( J Clin Oncol 38:2020. Suppl; abstr 8503). Limited data are available on pts’ experience with prior therapies and expectations on ide-cel. By embedding pt interviews in KarMMa, we assessed pts’ initial knowledge of and expectations on ide-cel beyond pt-reported outcome measures prior to ide-cel therapy. Methods: This qualitative study was conducted in triple-class exposed pts refractory to their last regimen who entered the KarMMa trial (NCT03361748). Pts were invited to participate in the optional interview component that included up to 11 interviews. We present results of the first interviews that occurred between initial consent and leukapheresis. The interview topics were pts’ initial knowledge of ide-cel, decision making, expectations, hopes, and concerns, and current well-being. All interviews were recorded, transcribed, and coded. Results: Forty-seven pts from 14 clinical sites participated in the interviews. Most pts were able to describe the overall process of CAR T cell therapy and one third first heard about the therapy from their local healthcare professionals. According to patients, key decision-making factors were potential outcomes with ide-cel, recommendation from a doctor, and lack of other options. The most frequently perceived differences between ide-cel and prior treatments are shown (Table). Pt hopes were mostly focused on remission and improved quality of life. Most pts reported some restrictions on their daily activities due to the disease. Conclusions: RRMM pts need new treatment options. Most pts reported the limitations of prior therapies, expectations on ide-cel, impact of the disease, and differentiated ide-cel from other treatments. The ongoing interviews will further assess pt experience during and after ide-cel therapy. Clinical trial information: NCT03361748 . [Table: see text]
Assessment and reporting of quality-of-life measures in pivotal clinical trials of hematological malignancies.
Authors: Al Hadidi Samer , Kamble Rammurti T. , Carrum George , Heslop Helen E. , Ramos Carlos Almeida 
Published: October 2020

158 Background: The importance of assessment and reporting of health related quality of life (QoL) has been increasingly recognized in the field of oncology. QoL measures, which reflect patient’s perceived benefits and satisfaction, might be especially important in hematological malignancies clinical trials, where the intervention may not result in cure with modest overall survival benefit. Methods: Data on health related QoL were obtained from studies’ protocols and product labeling available publicly at Drugs@FDA. Drugs approved from 2016 to 2020 were analyzed. On the basis of publicly available study protocols and Food and Drug Administration (FDA) reviews, the authors reviewed the assessment of health related QoL in 53 clinical trials supporting 50 drug approvals from 2016 to 2020. Those trials resulted in approval of medications to treat leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, myelodysplastic syndrome, and multiple myeloma. Results: A total of 14,819 patients were assessed in the 5 years period after exclusion of unpublished studies. We calculated the frequency of assessment of health related QoL and if QoL measures were reported in the subsequent publications. After exclusion of 7 unpublished studies, we analyzed 46 clinical trials for reporting of HRQOL. Thirty percent of the protocols included assessment of health related QoL with only 43% of them (13% of all the analyzed clinical trials) reported the results of health related QoL. The results were consistent across all subtypes of hematological malignancies and were similar regardless of the studied primary endpoint. Conclusions: QoL measures are under studied in clinical trials of hematological malignancies. Studies that measured health related QoL didn’t report the results in more than half of the time. Although results may be reported in separate future publications, improvement in assessing and reporting of QoL will help to incorporate QoL measures in patient care and therapy choice decision. [Table: see text]
Patient-reported outcomes (PROs) in older adults with gastrointestinal (GI) cancer undergoing surgery.
Authors: Knight Helen Perry , Fong Zhi Ven , Qian Carolyn L. , Kaslow-Zieve Emilia , Azoba Chinenye C. , Ferrone Cristina R. , Kunitake Hiroko , Fernandez-del Castillo Carlos , Lanuti Michael , Qadan Motaz , Ricciardi Rocco , Lillemoe Keith D. , Franco-Garcia Esteban , O'Malley Terrence A. , Jackson Vicki A. , Greer Joseph A. , El-Jawahri Areej , Temel Jennifer S. , Nipp Ryan David 
Published: October 2020

159 Background: Older adults with GI cancer often experience poor surgical outcomes, yet little is known about their PROs, such as physical function, quality of life (QOL), and physical and psychological symptom burden. Methods: As part of a randomized trial of perioperative geriatric care, we prospectively enrolled adults age ≥65 with GI cancer planning to undergo surgical resection. We asked patients preoperatively to self-report their physical function (activities of daily living [ADLs] and instrumental ADLs [IADLs]), QOL (EORTC QLQ-C30), symptom burden (Edmonton Symptom Assessment System [ESAS], scores > 3 considered moderate/severe [mod/sev]), depression symptoms (Geriatric Depression Scale [GDS], scores > 4 represent a positive screen for depression), and comorbidities. We used regression models to explore relationships among PROs and clinical outcomes (receiving planned surgery, postoperative complications [Clavien-Dindo], hospital readmissions within 90 days, and survival). Results: From 9/2016 - 4/2019, we enrolled 160 of 221 (72.4%) patients approached (median age: 72, range: 65-92). At baseline, most (53.1%) reported at least one comorbidity and required assistance with ADLs (94.8%) and IADLs (52.3%). Patients reported an average of 2.56 mod/sev ESAS symptoms, and 27.7% screened positive for depression. For surgical outcomes, 137 patients (85.6%) underwent planned surgery, and 99 (72.2%) of these had at least one postoperative complication. Greater independence with ADLs was associated with undergoing planned surgery (OR = 1.21, P = .02), lower risk of complications (OR = 0.81, P < .01), and improved survival (HR = 0.87, P = .02), but not readmissions. Greater independence with IADLs was associated with undergoing planned surgery (OR = 1.30, P = .03) and improved survival (HR = 0.73, P < .01), but not other outcomes. Higher baseline QOL was only associated with lower risk of postoperative complications (OR = 0.97, P = .04). Higher depression scores were only associated with worse survival (HR = 1.13, P = .02). Higher baseline symptom burden predicted for shorter time to readmission (HR = 1.13, p = .03). Patient-reported number of comorbidities was associated with shorter time to readmission (HR = 1.49, p = .03) and higher risk of complications (OR = 1.70, P = .03). Conclusions: Older adults with GI cancer often have baseline functional limitations and a high symptom burden, all of which are associated with worse clinical outcomes. Future work should study whether addressing preoperative PROs could improve older patients’ surgical outcomes. Clinical trial information: NCT02810652 .
Evaluating risk characteristics for patients who die within 30 days of hospitalization.
Authors: Kurian Christine , Hong Jennifer , McSweeney Andrea , N'Dri Laetitia , Walsh Karen , Binder Adam 
Published: October 2020

161 Background: Advanced cancer patients often receive aggressive end of life care despite questionable benefit. As a result, there are ongoing efforts to improve end of life care and coordinate palliative care supportive services. This study is an expansion of a previous study performed examining descriptive data in a population of oncology patients who died within 30 days of admission. Here, we compare patients who died within 30 days of admission against those who survived to evaluate differences in patient characteristics and healthcare utilization. Methods: Adult oncology patients who were admitted from 10/1/2018-3/30/2019 at an academic medical center were evaluated. Two groups of patients were studied–oncology patients who died within thirty days of admission and those who survived. The patients were selected using ICD-10 codes, EMR systems support, and manual chart review. Additionally, we examined demographic (i.e. gender, ethnicity, cancer diagnosis) and clinical characteristics (i.e. level of care, code status, previous palliative care consult, palliative care consult in the hospital, nutrition status, clinical trial status, advance care planning, hospice enrollment). Statistical analysis included chi-squared and ANOVA tests, and logistic regression models. Results: A total of 267 patients were included in the analysis. For all patients in the study, 38% had a change in code status during their admission. 26% of patients had palliative care involvement and 23% were known to palliative care prior to admission. Twenty three percent spent the duration of their admission in the ICU for their end of life care. Significant mortality-level variation was found compared to overall mean number of admissions for the past 6 months (ANOVA F=25.3, p<0.0001). We conducted a logistic regression and adjusted for ethnicity, number of admits in the last 6 months, and length of stay to identify the outcome of patients who died within 30 days of admission vs. those who did not. Factors associated with increased odds of mortality included the number of admits in the last 6 months (OR 1.753, 95% CI: 1.397-2.200). Length of stay did not increase one’s odds for mortality (OR 0.989, 95% CI: 0.965-1.014). Conclusions: Low utilization of palliative care and advanced care planning was seen widely in both populations. Previous hospitalization in the last 6 months was a predictor of mortality in this patient population.
Design of eSyM: An ePRO-based symptom management tool fully integrated in the electronic health record (Epic) to foster patient/clinician engagement, sustainability, and clinical impact.
Authors: Hassett Michael J. , Hazard Hannah , Osarogiagbon Raymond U. , Wong Sandra L. , Bian Jessica J , Dizon Don S. , Wedge Jason , Basch Ethan M. , Mallow Jennifer , McCleary Nadine Jackson , Dougherty David W. , Remick Scot C. , Brooks Gabriel A. , Mecchella John , Solberg Peter , Tasker Laura , Faris Nicholas , Pacheco Alicia , Cronin Christine , Schrag Deborah ,   eSyM Project Managers
Published: October 2020

164 Background: Chemotherapy and surgery can cause distressing symptoms, which can be a burden for health systems to address. Programs that directly engage patients, including electronic tracking of patient-reported outcomes (ePROs), can improve symptom control and decrease the need for acute care. Previous ePRO programs have relied on third party vendors with limited EHR integration, constraining their clinical utility and scalability. An integrated solution could offer distinct advantages. Methods: As part of NCI’s Moonshot-funded IMPACT consortium, 6 health systems and Epic built an electronic symptom management program (eSyM) based on the PRO-CTCAE questionnaire that is fully integrated into the EHR. The agile, user-centered design process engaged patients, clinicians, and institutions. The core functional components include: 1) symptom surveys in the postoperative period or between chemotherapy visits, 2) self-management tip sheets, 3) clinician alerts, and 4) dashboards for population management. Critical points of integration with supporting EHR functions and workflow impacts were identified; and major challenges of integration and implementation were described. Results: eSyM, which was implemented at two health systems (Baptist Memorial in Tennessee and Mississippi and West Virginia University Health) in the fall of 2019, required multiple supporting EHR functions: 1) access a secure, HIPPA-compliant patient portal/messaging system (MyChart); 2) record diagnosis, procedure and chemotherapy treatment plan data; 3) identify target populations and track metrics/events; 4) define and execute autonomous logic-based workflow rules; 5) generate reports for clinicians/patients; and 6) documentation. Major challenges included: 1) working within pre-existing EHR system standards and capabilities, which limited the ability to customize interfaces and workflows specifically for the eSyM use case; and 2) adapting to different EHR configurations and polices across multiple health systems. Conclusions: The eSyM build leveraged many existing EHR capabilities and overcame regulatory hurdles; but it required design and workflow compromise. Integration of ePRO-based symptom management programs into the EHR could help overcome barriers, consolidate clinical workflows, and foster scalability/sustainability. Ongoing efforts include launching eSyM at four more sites and evaluating its adoption, usability, and impact on clinical outcomes.
Protocol concordance and impact of protocol deviations on selected outcomes in delivery of high-dose methotrexate in acute lymphoblastic leukemia in Sri Lanka.
Authors: Gunasekera Sanjeeva , Vindula Geeth , Combs Ryan , Howard Scott C. 
Published: October 2020

17 Background: In Sri Lanka, children with acute lymphoblastic leukemia are treated on the UKALL 2011 protocol, which includes high-dose methotrexate (HDMTX) in high risk patients. Safe delivery of HDMTX is challenging in low resource settings, where deviation from accepted guidelines can occur frequently and result in toxicity, subsequent treatment delays, and in extreme cases, death. The goal of this study was to compare current practices to the treatment and supportive care details described in the protocol to identify the incidence and impact of guideline-discordant care to deliver HDMTX more safely children with cancer in Sri Lanka. Methods: We reviewed medical records to assess guideline concordance in 4 critical aspects of HDMTX delivery: 2 consecutive alkaline urine pH readings in the 2-hour period before starting HDMTX, 24-hour duration of MTX infusion (as opposed to early stop), the first dose of folinic acid administered later than 36 hours from start of HDMTX infusion (no inappropriately early rescue), and the administration of at least 3 folinic acid doses per course (appropriate duration of rescue). We analyzed how each deviation influenced AKI (creatinine increase of 0.3 mg/dL or more), infection, and treatment delays (defined as recovery delayed 7 days or longer from the 14 days expected between courses of HDMTX). Results: We analyzed 309 HDMTX courses in 91 patients younger than 20 years, including 105 girls (34%). In 83 courses (27%) alkaline urine was not documented prior to the start of MTX. Infusion time was less than 24 hours in 239 courses (77%), most of which finished 20-21 hours. In 37 courses (12%), the first folinic acid dose was given inappropriately early, and in 25 courses (8%) less than 3 doses of folinic acid were given. There were 2 episodes of AKI, 43 infections, 11 treatment delays and one death. None of the 4 guideline deviations were significantly associated with AKI or treatment delays. Patient sex was also not associated with any difference in guideline discordance or outcome (p>0.1 in all cases). Conclusions: Significant deviations from HDMTX administration guidelines were common, especially early completion of infusion. However, outcomes were not impacted so quality standards may require adjustment to focus only on extreme deviations likely to impact patient outcomes.