bluuebunny/crossref_metadata_2025 huggingface dataset:
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

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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.
Machine learning to classify clinically meaningful patient groups by ESAS symptom clusters in oropharyngeal cancer patients undergoing initial treatment.
Authors: Haddad Ghazal , Hueniken Katrina , Bratman Scott Victor , de Almeida John R , Goldstein David Paul , Huang Shao Hui , Hansen Aaron Richard , Hope Andrew J. , Spreafico Anna , Xu Wei , Liu Geoffrey
Published: October 2020

171

Background: Cancer patients often experience symptoms in clusters, which could contribute to patient outcomes and quality of life; yet most analyses describe only individual symptom scores or a summation of symptom scores rather than symptom clusters. We compared machine learning to traditional statistical methods for grouping patients by symptoms in a heavy symptom burden patient population: oropharyngeal cancer patients undergoing initial treatment with radiation or chemoradiation (C/RT). Methods: K-means clustering was compared to traditional statistical methods (i.e., histogram-analysis; use of quantiles; categorization by clinico-demographic features) for classifying patients based on Edmonton Symptom Assessment System (ESAS) symptom scores in newly diagnosed oropharyngeal cancer patients before and after C/RT initiation. Results: 278 patients were classified into 3 K-means groups at each of two timepoints: pre-C/RT and post-C/RT. These groupings were formed primarily based on differences by symptom burden and were thus labeled: low, moderate, and high symptom-burden patient groups. The table shows dynamic change as patients moved from group to group during C/RT treatment. Greatest symptom-burdens in pre-C/RT patients were anxiety and tiredness; in post-C/RT, poor appetite and tiredness. Chi-squared residuals attributed being female (residuals of -3.95 for low, -2.46 for moderate, and 2.41 for high burden) and HPV-negative cancer (residuals of -1.48, -0.52, and 2.57, respectively) to being associated with higher symptom burden pre-C/RT; no clinico-demographic characteristics were associated with high symptom burden post-C/RT, suggesting this was a previously unidentified patient group. Although separation into K-means clusters in this population was primarily related to symptom burden, K-means better identified the number of patient groups and classified patients at the boundaries between groups (involving up to a quarter of patients) when compared to traditional statistical methods. Conclusions: Machine learning clustering analysis separated patients into discrete groups by symptom burden. K-means provided an objective means for clustering patients in a clinically-meaningful way when compared to traditional statistical methods for grouping patients. [Table: see text]
Electronic patient-reported outcomes (ePRO) platform engagement in cancer patients during COVID-19.
Authors: Frailley Susan A , Blakely L. Johnetta , Owens Leah , Roush Ashley , Perry Toni S. , Hellen Veera , Dickson Natalie R.
Published: October 2020

172

Background: Tennessee Oncology partnered with an ePRO platform solution to support patients during their cancer care journey. This cloud-based ePRO platform is designed to assist in improving the management of symptoms. Providing two core pieces of functionality allow both the patient and care teams to retrieve information quickly and communicate effectively. The patient portal is patient input driven and allows the patient to communicate with their care team, track symptoms, and access their health records via website or mobile app. The clinician portal provides multiple care teams the ability to manage and prioritize patient needs as well as communicate directly with patients. In March 2020, due to the pandemic, patients needed a convenient and remote way to communicate with the care team. Our communication plan had to be nimble and provide immediate updates to our large patient population. We leveraged our ePRO platform to meet this need. Methods: We focused efforts on increasing patient engagement by educating them on the benefits of this communication platform. We utilized secure messaging to send appointment details and for Telehealth visits a link to the visit was sent. We were able to provide weekly updates outlining our latest information regarding our safety protocols. Results: We noted an increase in the activation of patient accounts and patient-initiated messages in our ePRO platform. We saw an average of 1,000 new patient accounts activated each month during March, April and May. We saw that patient-initiated messages through the platform showed a 15% increase from February to March. The response rate for patients completing post-treatment questionnaires increased 8% from February to May. Conclusions: By providing patients with a single communication platform to contact their care teams outside of their office visits, patients become an active part of their care journey. As an organization, we continue to identify ways to connect our patients to their care team in a meaningful way through technology. Whether during normal business hours or after-hours, patients need a simple, reliable and consistent way to engage with their care team.
Associations between perceptions of care experiences and receipt of mental health care among older adults with cancer.
Authors: Lines Lisa M , Barch Daniel H , Zabala Diana , Halpern Michael T. , Jacobsen Paul , Mollica Michelle
Published: October 2020

175

Background: Older adults with cancer and worse self-rated mental health report worse care experiences. We hypothesized that, controlling for health and demographic characteristics, older adults with cancer who received care for anxiety or mood disorders would report better care experiences. Methods: We used SEER-CAHPS data to identify Medicare beneficiaries, aged 66 and over, diagnosed from August 2006 through December 2013 with one of the 10 most prevalent solid tumor malignancies. To identify utilization for anxiety or mood disorders (screening, diagnosis, or treatment), we analyzed inpatient, outpatient, home health, physician, and prescription drug claims from 12 months before through up to 5 years after cancer diagnosis. Outcomes of interest were global care experience ratings (Overall Care, Personal Doctor, and Specialist; rated on a 0-10 scale) and composite measures (Getting Needed Care, Getting Care Quickly, and Doctor Communication; scored from 0-100). We estimated linear regression models and also used a Bayesian Model Averaging approach, adjusting for standard case-mix adjustors (including sociodemographics and self-reported general health and mental health status [MHS]) and other characteristics, including cancer site and stage at diagnosis. We also included interaction terms between mental health care utilization and MHS. Results: Approximately 22% of the overall sample (n = 4,998) had both cancer and a claim for an anxiety or mood disorder, and of those individuals, 18% reported fair/poor MHS. Only 7% of those in the cancer-only cohort reported fair/poor MHS. Before adjusting for mental health utilization, worse MHS was significantly associated with worse experience of care. After accounting for anxiety/mood disorder-related utilization, linear regression models showed no significant associations between fair/poor MHS and worse care experiences, while Bayesian models found that reliable associations remained between worse MHS and lower global ratings of Overall Care and Specialist. Conclusions: Utilization for anxiety/mood disorders mediates the association between fair/poor MHS and worse care experiences. Although MHS is a case-mix adjustor for CAHPS public reporting, it is important to recognize that care for anxiety or mood disorders may improve care experiences among seniors with cancer.
Initial pilot testing of a smartphone app for detection of chemotherapy-induced peripheral neuropathy.
Authors: Hertz Daniel Louis , Chen Ciao-Sin Chelsea , Kim Judith Louis , Guntupalli Harsha , Dorsch Michael , Callaghan Brian , Garg Noemi , Jagsi Reshma , Griggs Jennifer J. , Sabel Michael S.
Published: October 2020

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Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect that manifests in the hands or feet primarily as numbness or tingling but can also have motor or painful components. CIPN monitoring is typically conducted by patients self-reporting symptoms during appointments or via questionnaires. Objective CIPN testing may improve early detection but is not typical during treatment, perhaps due to the need for specialized equipment and personnel. The objective of this pilot study was to conduct initial testing of a smartphone app that collects patient-reported and objective CIPN data. Methods: NeuroDetect V1.0 (available in iOS app store) includes a patient-reported CIPN questionnaire (EORTC CIPN20) and two functional assessments available within ResearchKit, the Gat and Balance and 9-Hole Peg tests. Patients who had completed neurotoxic chemotherapy were enrolled to complete NeuroDetect assessments one time. Study participants were classified as CIPN cases if they answered ≥ 3 for at least one of the first four CIPN20 questions, which ask about numbness or tingling in the hands or feet on a 1-4 scale. User acceleration data features were extracted with two open source tools, mhealthtools and pdkit. The results of the functional assessments were compared between CIPN cases and controls in principal component analysis and partial least squares discriminant analysis. Results: Twenty-four patients who had completed neurotoxic chemotherapy enrolled and completed the NeuroDetect assessments. Integration across all 87 features measured in the gait and balance test explained 42% of the difference between CIPN cases (n = 14) and controls (n = 10) and 9 individual features were significantly different between cases and controls (all p < 0.05). In the 9-hole Peg Test, hand speed explained 77% of the difference between CIPN cases and controls. CIPN cases took longer to complete the 9-hole peg test though the difference was not statistically significant (dominant hand mean 407.3 vs. 406.2 ms, p = 0.075). Conclusions: App-based functional assessment may detect evidence of CIPN. We are developing additional CIPN functional assessments for NeuroDetect V2.0 to test CIPN detection in a longitudinal study of patients undergoing neurotoxic chemotherapy.
Associations of care experiences with survival among people with cancer in SEER-CAHPS, 2006 to 2017.
Authors: Dimartino Lisa , Kirschner Justin , Huebeler Amy , Jackson George L. , Mollica Michelle , Lines Lisa M
Published: October 2020

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Background: A growing body of literature indicates associations between cancer care experiences and survival. Several studies suggest people with cancer who report worse care experiences have greater mortality. However, studies in general patient populations have found worse care experiences are associated with lower mortality. To our knowledge, no study has evaluated the relationship between care experiences and survival using a large, nationally representative sample of cancer patients. Methods: We used linked SEER cancer registry-Consumer Assessment of Healthcare Providers and Systems (CAHPS) data to identify people diagnosed 8/2006-12/2013 with one of the top ten solid tumor cancer sites with the highest mortality rates among those over age 65 (lung, colon, prostate, pancreas, breast, bladder, ovary, esophagus, kidney, or liver cancers). We included people who completed a survey between 6-24 months post-diagnosis and were continuously enrolled in Medicare A & B from ≤6 months pre-diagnosis through survey completion. CAHPS outcomes were ratings of Overall Care, Specialist Physician, Health Plan, and Prescription Drug Plan (PDP) and composite scores of Getting Needed Care. We used survey-weighted Cox proportional hazard models to compare those who gave lower (0-8) vs higher ratings (9-10), and lower (0-89) vs higher (90-100) scores. Results: We identified 2,403 eligible people. Mean survival was 46 months and 26% died by 5 years after diagnosis. In unadjusted models, lower Overall Care ratings were significantly associated with higher mortality (HR=1.25, p=.04), but this did not persist in the adjusted model. In contrast, lower ratings of PDP were significantly associated with lower mortality after covariate adjustment (HR=.63, p=.02). Conclusions: Except for PDP, survival was similar among those with worse vs better care experiences. People with better cancer prognoses may perceive worse services from their PDP compared to those with poorer prognoses. Future research examining mechanisms underlying this association may be warranted. [Table: see text]
Understanding patient perspectives on window of opportunity clinical trials.
Authors: Parikh Divya Ahuja , Kody Lisa , Brain Susie , Heditsian Diane , Lee Vivian , Curtis Christina , Sledge George W. , Caswell-Jin Jennifer Lee
Published: October 2020

181

Background: In “window of opportunity” (WOO) clinical trials, people with newly diagnosed early-stage cancer are exposed to an experimental drug during the period of time between diagnosis and definitive anti-cancer treatment. These trials allow investigators to study drug efficacy in untreated disease, which can expedite drug development. However, for trial participants, the WOO approach requires them to decide about an altruistic clinical trial during an intense time immediately after cancer diagnosis. This qualitative study aimed to understand patient perspectives on WOO clinical trials. Methods: We recruited adults newly diagnosed with early-stage breast cancer who were awaiting definitive therapy at a single academic medical center. We developed an interview guide grounded in the theoretical framework, the Theory of Planned Behavior (TPB). TBP is a well-validated decision-making model with three domains that guide behavior: (1) attitudes (2) normative factors and (3) perceived difficulty of a behavior. We conducted one-on-one semi-structured interviews that were audio-recorded and transcribed. Transcripts were analyzed to ensure interrater reliability and content analysis was performed to assess themes that emerged. Results: We interviewed 15 women (age 32-72) with early-stage breast cancer, and the majority were White (n = 12, 80%) and at least college educated (n = 12, 80%). Key themes that emerged included favorable attitudes towards participating in a WOO trial that were altruistic, including the desire to contribute to science (n = 10, 67%) and to help future breast cancer patients (n = 5, 33%). Several individuals also identified a potential benefit to themselves (n = 10, 67%), including access to a targeted drug (n = 4, 27%) and adding meaning to their diagnosis (n = 3, 20%). However, most interviewees reported concerns about drug side effects (n = 12, 80%) and whether side effects would impact other planned treatments (n = 10, 67%). Interviewees also expressed family would be an important normative factor in decision-making (n = 8, 53%). A key theme that emerged as a difficulty was the potential delay in standard treatment (n = 14, 93%). Despite this concern, at the end of the interviews, most interviewees stated they would participate in a WOO trial if offered (n = 10, 67%). Conclusions: WOO trials are becoming increasingly common in oncology research. In this qualitative study, interviewees weighed altruism against the possibility delaying or impacting other treatments. Our results may inform trial design and communication approaches in future WOO efforts.
C-CRES: COVID-19 and cancer research engagement study.
Authors: Fox Louis , Wylie Harriet , Cahill Fidelma , Haire Anna , Kibaru Joyce , Green Saran , Hartley Catherine , Sullivan Richard , Van Hemelrijck Mieke
Published: October 2020

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Background: Emerging reports suggest that continuation of clinical trials is feasible and safe even in hospitals admitting COVID-19 patients-given the appropriate safety procedures. However, to our knowledge no studies have yet addressed how to again engage patients in cancer research. C-CRES was developed to identify factors that may be affecting participation in cancer research during the COVID-19 pandemic. We aimed to examine patient-specific concerns around research participation. This information will help inform future strategies for mitigating the impact of COVID-19 on cancer research. Methods: Between 5-13 June 2020, we advertised an anonymous survey using our research group’s Twitter account and tagged a variety of cancer patient organisations/charities. Patients aged 18 with a current cancer diagnosis were eligible to participate and asked about their diagnosis/treatment, experience in cancer research, and beliefs about future cancer research participation given the COVID-19 pandemic. We specifically asked about potential concerns relating to research engagement. Results: A total of 75 patients filled out our questionnaire, of whom 89% were UK-based. 65% of respondents were male and the majority was of a white background (89%). The median age category was 60-69 years. 47% of patients had prostate cancer, 15% breast, 12% bladder, and 9% kidney cancer–a reflection of the cancer types our research team focuses on. Interestingly, 49% of participants had never participated previously in research. We therefore set out to make comparisons of patient concerns with regards to research participation during the COVID-19 outbreak between those with and without research experience. Those who had never taken part in research before were more likely to have concerns about currently being on cancer treatment (p=0.02) and about the type of cancer they had been diagnosed with (p≤0.05), with regards to taking part in cancer research during the current COVID-19 outbreak. Conclusions: Those with no prior experience of taking part in cancer research may be more likely to have concerns related to their cancer type and current treatment, in terms of participation during COVID-19. Efforts should be made to reassure potential cancer research participants about safety of participating during the COVID-19 pandemic.
Improving timeliness of care for breast, GYN, and aerodigestive cancer patients with nurse navigators in a safety net hospital.
Authors: Rehr Christine , Carter Teralyn , Flenaugh Eric , Wang Zhensheng , Ohaegbulam Gail , Matthews Roland , Mishra Pooja , Facdol Jamil , Coples Susan , Thomas Dana , Garrett Rosalyn , Gabram Sheryl G. A.
Published: October 2020

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Background: The Georgia Cancer Center for Excellence (GCCE) at Grady received a 5-year MERCK Patient Centered Grant in 2017 that focuses on improving care to vulnerable cancer patients (pts) through the introduction of nurse (RN) navigators, a dietician and a part time exercise coach. A review of the literature shows improved patient outcomes and satisfaction with decreased time to treatment for breast and lung cancer pts. [1-2] RN navigation has been shown to expedite care and one of our goals for the MERCK grant was to study the effect of introducing RN navigation in a safety net hospital for three cancer sites. Methods: Three RN navigators were hired for the Breast, GYN and Aerodigestive cancer programs since 2017. RN navigators meet all newly diagnosed cancer pts during clinic and track their progression of care, often intervening for timeliness of work up and treatment. Each RN navigator keeps a record of pts navigated. An audit of this prospectively collected data measuring time from diagnosis to treatment for breast, GYN and aerodigestive cancer pts took place for 2018 and 2019. Inclusion criteria: diagnosed and treated at Grady, navigated by RN, and not Stage IV disease. Results: The total numbers of cancer pts navigated over the past two years were 244 breast, 131 GYN, and 265 aerodigestive pts. Using the inclusion criteria described in the methods section, the time from diagnosis to treatment decreased for these three cancer sites (see Table). Conclusions: Implementation of RN navigators within the cancer program trended towards decreases in time from diagnosis to treatment for our breast, GYN, and aerodigestive cancer patients. These measurable improvements over three cancer sites are largely attributed to RN navigation and suggest that cancer outcomes will improve over time for our patients treated in our safety net hospital. We plan to study patients who were retained in the system or were adherent to care to better understand the importance of RN navigation in our system. References: (1)Bleicher RJ, Ruth K, Sigurdson ER, et al. Time to Surgery and Breast Cancer Survival in the US. JAMA Oncol 2016;2(3):330–339. (2) Olsson JK, Schultz EM, Gould MK. Timeliness of care in patients with lung cancer. Thorax 2009;64:749-756. [Table: see text]
Improving the quality of oral cancer drug delivery across a health system.
Authors: Enright Katherine , Ku Rosemary , Gallo-Hershberg Daniela , Pardhan Aliya , Forbes Leta Marie
Published: October 2020

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Background: Oral systemic therapy (ST) presents unique care delivery challenges. Gaps in patient education and monitoring for patients on oral ST delivery are well documented and can result in decreased adherence or increased toxicity. Within Ontario, cancer care is provincially coordinated through Ontario Health- Cancer Care Ontario (OH-CCO), but locally implemented by 14 Regional Cancer Programs (RCPs). Using a centrally coordinated, but regionally implemented quality improvement (QI) approach, we aimed to improve the quality of oral ST delivery across Ontario by enabling the use of patient specific monitoring plans to optimize treatment adherence and toxicity management. Methods: Between 2018 and 2020 a 2 year focused QI project was undertaken. A suite of 19 quality measures were developed to measure different quality domains for oral ST delivery including treatment plan documentation, patient education, toxicity/adherence monitoring and toxicity outcomes. In year 1, all regions used the suite of quality measures to establish baseline performance and develop a QI plan using rapid cycle improvement methodology to improve performance in at least 1 domain based on regional gaps and priorities. Projects were implemented and evaluated during year 2. OH-CCO provided QI coaching through dissemination of standardized QI tools, a monthly discussion forum and project specific feedback. At the end of year 2, a post-implementation evaluation was performed for each region. Results: 15 centers participated, representing all RCPs across Ontario. The participating centers implemented QI projects focused on treatment plan documentation (N = 3), patient education (N = 10) and toxicity/adherence management (N = 5), with some focusing on multiple domains. All centers reported an improvement in at least 1 domain (see Table). Key enablers identified include engagement with a multi-disciplinary team and the use of technology, while barriers include lack of onsite dispensing pharmacy. Future work will continue to focus on quality of oral ST delivery and better pharmacy integration. Conclusions: Through a centrally coordinated, locally implemented QI project, improvement in quality of oral ST care was achieved across Ontario. This model of QI focus has the potential to be adaptable across health systems. [Table: see text]
Use of patient-reported outcomes (PROs) to predict treatment outcomes in patients with advanced cancer.
Authors: Parikh Aparna Raj , Van Seventer Emily E. , Fish Madeleine , Fosbenner Kathryn , Kanter Katie , Mojtahed Amirkasra , Allen Jill N. , Blaszkowsky Lawrence Scott , Clark Jeffrey William , Du Bois Jon S. , Franses Joseph Wang , Giantonio Bruce J. , Goyal Lipika , Klempner Samuel J , Roeland Eric , Ryan David P. , Weekes Colin D. , Horick Nora K. , Corcoran Ryan Bruce , Nipp Ryan David
Published: October 2020

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Background: PROs assessing quality of life (QOL) and physical symptoms often correlate with clinical outcomes in patients (pts) with cancer. Yet, data are lacking about the use of PROs to predict treatment response. We evaluated associations of baseline PROs with treatment response, healthcare use, and survival among pts with advanced gastrointestinal cancer. Methods: We prospectively enrolled pts with metastatic gastrointestinal cancer prior to initiating chemotherapy at Massachusetts General Hospital. At baseline (start of treatment), pts reported their QOL (Functional Assessment of Cancer Therapy General [FACT-G], subscales assess QOL across 4 domains: functional, physical, emotional, social well-being) and symptom burden (Edmonton Symptom Assessment System [ESAS]). Higher scores on FACT-G indicate better QOL, while higher scores on ESAS represent a greater symptom burden. We used regression models to examine associations of baseline PRO scores with treatment response (clinical benefit [CB] or progressive disease [PD] at the time of first scan based on clinical documentation), healthcare use (unplanned hospital admissions), and survival. Results: From 5/2019-3/2020, we enrolled 112 of 131 (85.5% enrollment) consecutive pts (median age = 62.8, 61.6% male, 45.5% pancreatobiliary cancer). For treatment response, 64.3% had CB and 35.7% had PD. Higher ESAS-physical (B = 1.04, p = .027) and lower FACT-G functional (B = 0.92, p = .038) scores at baseline were significant predictors of PD. On the specific ESAS items, pts who experienced PD were more likely to report moderate/severe poor well-being (57.9% vs 29.7%; p = .001), pain (44.7% vs 25.0%; p < .050), drowsiness (42.1% vs 20.3%; p = .024), and diarrhea (23.7% vs 4.7%; p = .008) at baseline. Lower FACT-G total (HR = 0.96, p = .003), FACT-G physical (HR = 0.89, p < .001), FACT-G functional (HR = 0.87, p < .001), and higher ESAS-physical (HR = 1.03, p = .028) scores at baseline were significantly associated with greater risk of hospital admission. Lower FACT-G total (HR = 0.96, p = .009), FACT-G emotional (HR = 0.87, p = .014), as well as higher ESAS-total (HR = 1.03, p = .018) and ESAS-physical (HR = 1.03, p = .040) scores at baseline were significantly associated with greater risk of death. Conclusions: We found that baseline PROs predict treatment response in pts with advanced cancer, namely physical symptoms and functional QOL, in addition to healthcare use and survival outcomes. These findings further support the use of PROs to predict important clinical outcomes, including the novel finding of treatment response.
Trends in short-term, long-term, and high-risk opioid use among older cancer patients.
Authors: Salans Mia A , Riviere Paul , Vitzthum Lucas , Nalawade Vinit , Murphy James Don
Published: October 2020

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Background: While opioids represent a cornerstone of cancer pain management, the timing and patterns of persistent and high-risk opioid use in the context of the ongoing opioid epidemic are not well studied. This study sought to explore longitudinal trends in short-term, long-term, and high-risk opioid use among older cancer patients. Methods: Within a cohort of 84,994 Medicare beneficiaries ≥ 65 years old diagnosed with cancer between 2007 and 2013, we determined the likelihood of being prescribed an opioid after cancer diagnosis (0-6 months, 6-12 months, and 1-2 years post-diagnosis) and of receiving a daily morphine equivalent dose (MED) ≥ 200 mg, a dose associated with higher opioid-related mortality. Multivariable logistic regression models were used to identify patient and cancer risk factors associated with outcomes. Results: The rates of opioid prescription at 0 to 6 months, 6 to 12 months, and 1 to 2 years after diagnosis were 60.7%, 32.7%, and 38.2% respectively. Among patients who were prescribed an opioid, 4.0% received a MED ≥ 200 mg within 2 years of diagnosis. The likelihood of opioid prescription 0 to 6 months after diagnosis increased over the study period (OR = 1.05 per year, CI = 1.04 to 1.06), while the likelihood of opioid prescription 6 to 12 months (OR = 0.98 per year, CI = 0.97 to 0.99) and 1 to 2 years (OR = 0.98 per year, CI = 0.97 to 0.99) after diagnosis decreased over the study period. The probability of receiving a MED ≥ 200 mg decreased over the study period (OR = 0.98 per year, CI = 0.96 to 0.99). On multivariable analysis, Black (OR = 1.14, CI = 1.06 to 1.23) and American Indian/Native Alaskan (OR = 1.46, CI = 1.06 to 2.02) patients were more likely to receive opioids 1 to 2 years after diagnosis. Patients living in areas with higher rates of poverty (OR = 1.40, CI = 1.32 to 1.48) were also more likely to receive an opioid 1 to 2 years after diagnosis. Black (OR = 1.72, CI = 1.59 to 1.86), Asian (OR = 1.46, CI = 1.19 to 1.80), and Hispanic (OR = 1.36, CI = 1.23 to 1.51) patients were more likely to receive a MED ≥ 200 mg. Conclusions: While the rate of short-term opioid use is rising, rates of persistent and high-risk opioid use are declining among cancer patients. This may reflect growing awareness of the dangers of opioid misuse among clinicians treating patients with cancer. Nevertheless, racial and socioeconomic disparities in patterns of opioid use are persistent in the cancer population.