bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of increased understanding of personal and family health history on patients.
Authors: McCain Lynn A. , Hulswit Bailey , Milliron Kara J. , Cook Amanda , Keren David , Schroeder Lee , Merajver Sofia , Tippie Jerry 
Published: October 2020

256 Background: The InheRET personal and family health history survey was administered to 384 patients at three Michigan Medicine Clinics (2 primary care (11% of patients) and one breast and ovarian cancer risk clinic (89% of patients)) between October 1, 2018 and May 31, 2019. Since family history alone misses ~30% of those with deleterious germline mutations, this study follows these patients to determine what, if any, impact completion of the histories had on patients’ lifestyle choices, cancer prevention screenings, and risk-reducing therapies adopted based on perceived risk status: Meeting or not meeting NCCN Guidelines for referral to genetics for further evaluation. Methods: One year after patients completed their health histories, a follow-up survey was emailed to patients inquiring into actions taken following completion of the InheRET health history form. Anonymous responses were automatically collected into a Google Datasheet and analyzed. Results: As of June 16, 2020, 61 patients had returned their surveys; 37 (60.7%) reported being referred to a genetics specialist, of whom 92% kept their counseling appointments and 100% of these were recommended to be tested. At the time of survey completion, 29 patients had been tested and 32 patients had not been tested. We analyzed the actions taken between these two groups and discovered that 75% of patients who did not meet NCCN Guidelines and were not recommended for counseling and testing (population risk patients) still made lifestyle changes to improve their health and engaged in at least one cancer screening activity in the past year to reduce their cancer risk. The only preventive medical treatments received by this group were Tamoxifen (12.9%) and Hormone Replacement Therapy (3.2%). Among patients meeting NCCN Guidelines and tested (4 positive, 17 negative, 8 inconclusive/VUS/unknown results), 58.6% made positive lifestyle choices, 86.5% engaged in one or more cancer screening activities, and 34.5% sought additional medical interventions such as chemoprevention, hormone replacement and/or prophylactic surgery. Conclusions: By learning more about their personal and family health histories, patients who did not meet referral guidelines and were not referred for counseling and testing were proactive in taking actions to improve their overall health and reduce their cancer risk. This demonstrates the importance of knowing and understanding one’s family health history, even for those not meeting NCCN referral guidelines.
Utilization of telemedicine to meet the demand throughout the COVID-19 pandemic at a community oncology practice.
Authors: Bilbrey Larry Edward , Frailley Susan A , Poole Stacey L , Crouse Cheryl , Trader Amanda , Blakely L. Johnetta , Frailley Luke , Dickson Natalie R. 
Published: October 2020

263 Background: A large community oncology practice in Tennessee participates in value-based payment arrangements, the success of which depends on close patient monitoring. Telemedicine as an innovative solution was initiated in 2017. The service was limited, due to regulation, licensure requirements, and lack of reimbursement, to survivorship visits, clinical trial consent visits, rural hospital consults and genetic counseling. During the COVID pandemic and loosening of restrictions, telemedicine services were expanded. Methods: We identified a cloud-based platform that allowed patients to use any device with a camera and microphone and required no software downloads. On-line training sessions were provided to clinical staff. All training and workflow implementation were completed in a 2-week time frame. Telemedicine was expanded to include surveillance, urgent care, psychology, palliative care and post-BMT visits as well as new patient consults for medical, radiation and gynecologic oncology patients. Patient satisfaction surveys were administered. Results: Our telemedicine visits increased weekly beginning March 1, peaking in the month of April with an average of 77 scheduled telemedicine visits per day across the practice. During the month of April, our practice saw a record clinical trial accrual in our Phase-1 Drug Development Unit with a 22% increase over the previous average. Patients who responded to a satisfaction survey were highly satisfied with the telemedicine visit with a 73% positive response rate. Nearly half of our eligible patients did not have the technology or broad-band access to be able to participate in telemedicine. Conclusions: Our prior experience with telemedicine, though limited, facilitated the development of an infrastructure that provided adequate number of devices and internet bandwidth capacity to support rapid expansion of telemedicine. We were able to maintain high quality care and access to clinical trials during the pandemic and see the value of this service long-term. We hope to add tele-pharmacy and care coordination services. Political leadership and patient advocacy groups should explore ways to ensure that all patients may benefit from this technology, especially those in under-served areas.
Real-world clinical outcomes in avelumab-treated patients (pts) in the United States (U.S.) from SPEAR-Merkel: Study informing treatment pathway decisions in Merkel cell carcinoma (MCC).
Authors: Bhanegaonkar Abhijeet , Liu Frank Xiaoqing , Kim Ruth , Boyd Marley , Fulcher Nicole , Krulewicz Stan , Kasturi Vijay , Cowey Charles Lance 
Published: October 2020

269 Background: MCC is a rare, aggressive disease associated with poor prognosis. Avelumab, a fully human anti–PD-L1 monoclonal antibody, was the first immune checkpoint inhibitor approved by the FDA for the treatment of metastatic MCC (mMCC). In the JAVELIN Merkel 200 trial (Clinical trial information: NCT02155647), avelumab resulted in durable responses and a high objective response rate (ORR) in pts with mMCC. This retrospective descriptive study assessed real-world clinical outcomes in avelumab-treated pts with locally advanced MCC (laMCC) and mMCC in a US community oncology setting. Methods: This study included data on avelumab-treated laMCC and mMCC pts from 1/1/17 to 3/31/19 within The US Oncology Network. Study data were captured through 9/30/19 using structured fields and chart review of iKnowMed electronic healthcare records. Real-world ORR was assessed. Duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method. Results: 33 pts initiated treatment with avelumab (laMCC n = 11; mMCC n = 22) and were followed up for a median of 10.9 months (range, 0.5-27.2 months). Median age was 77 years (range, 44-90+ years), 78.8% of pts were male, and the majority (84.8%) of pts were treated in the first-line setting. During treatment, 27.2% of pts had emergency department visits and 39.4% were hospitalized; 1% and 23.1%, respectively, were treatment related. Clinical outcomes are reported in the table. Conclusions: This is the first study to examine pts with laMCC treated with avelumab in a real-world setting. Although the sample population is small, results suggest the clinical benefits in the real world in pts with mMCC treated with avelumab are consistent with benefits reported in the JAVELIN Merkel 200 trial. [Table: see text]
Real-world evidence for U.S. Food and Drug Administration-approved oncology products, 2015 to 2020.
Authors: Arondekar Bhakti , Duh Mei Sheng , Bhak Rachel , DerSarkissian Maral , Huynh Lynn , Wang Kelsey , Davis Eric , Wornson Bryon 
Published: October 2020

280 Background: Since the 21st Century Cures Act, there has been growing interest in using real-world evidence (RWE) to support regulatory filings for new drugs and indications. The goal of this study was to provide a comprehensive source of RWE use cases of U.S. Food and Drug Administration (FDA) approvals for oncology products. Methods: A systematic review of FDA new drug applications (NDAs) and biologics license applications (BLAs) from 1/2015-2/2020 for approved oncology products was performed. Data on the RWE study were extracted (data source, study design, statistical methods, results), and corresponding FDA comments were synthesized to identify patterns of the FDA’s review. Results: We identified 102 NDAs and BLAs, 8 (8%) of which included RWE, all post-Cures Act (see Table). RWE supporting avelumab, axicabtagene ciloleucel, and avapritinib were received positively and used by the FDA in their approval decision. RWE results were used to provide contextualization to the pivotal trial, rather than statistical comparison. Common data sources included Flatiron (38%) and chart reviews (38%). FDA critiques included lack of a priori study protocol, incomparability with the pivotal trial population and endpoints, and uncontrolled confounding. Conclusions: There have been few examples of RWE in oncology submissions, and most served to complement clinical trial results. To meet FDA standards, RWE studies should be clearly designed and discussed with the FDA and include robust methods to minimize bias. [Table: see text]
A geriatric assessment (GA) intervention for older patients with advanced cancer: Secondary outcomes from a University of Rochester cancer center NCI community oncology research program cluster randomized controlled trial (CRCT).
Authors: Mohile Supriya Gupta , Mohamed Mostafa , Xu Huiwen , Patil Amita , Culakova Eva , Ramsdale Erika E. , Loh Kah Poh , Magnuson Allison , Flannery Marie Anne , Gilmore Nikesha , Dunne Richard Francis , Obrecht Spencer , Plumb Sandy , Lowenstein Lisa M , Mustian Karen Michelle , Morrow Gary R. , Hopkins Judith O. , Gaur Rakesh , Berenberg Jeffrey L. , Dale William 
Published: October 2020

33 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients (pts) with advanced cancer receiving high risk treatment (presented @ASCO2020). Herein, we report secondary outcomes on the effects of the GA intervention on aging-related outcomes. Methods: Pts aged ≥ 70 with incurable solid tumors or lymphoma and ≥ 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations) or usual care (none given). Secondary analyses examined effects of the intervention on functional outcomes (patient-reported falls, instrumental activities of daily living (IADL), short physical performance battery (SPPB), geriatric depression scale (GDS), and medications [total and prescription]). Outcomes were analyzed using linear mixed effects model, logistic or Poisson regression adjusted for baseline values, time, and site effects as appropriate. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by arm. More pts in intervention were black (12% vs 3%, p<0.01), had GI cancer (38% vs 31%, p<0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Overall, 16.4% of all pts had one new fall over 3 months; patients in the intervention arm were significantly less like to fall over 3 months (11.7% vs 20.7%; Risk Ratio 0.58; 95% CI 0.40-0.84, p=0.004). There was no difference in the total number of medications (mean 5.86 vs 5.79, p=0.80) and prescriptions (mean 4.26 vs 4.20, p=0.70) at baseline. More medications (adjusted mean 0.23 vs 0.09, p=0.03) and prescriptions (0.19 vs 0.07, p=0.05) were discontinued during intervention, although there was no difference at 3 month follow up. There were no significant between-arms differences in IADL, SPPB, and GDS. Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience a fall over 3 months and improves polypharmacy; both of these endpoints are of clinical importance to older adults with aging-related conditions and advanced cancer undergoing palliative treatment. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741 .
Health care coach support in reducing acute care use in patients with cancer.
Authors: Patel Manali I. , Smith Kim , Sisay Etsegenet , Park David J. 
Published: October 2020

4 Background: Lay health workers (LHWs) who are trained to proactively discuss goals of care and assess patient symptoms have improved value-based cancer care among Veterans and a Medicare Advantage population. Little data exists regarding the effect of integrating LHWs into community oncology care among commercially insured populations. In this study, we implemented an LHW intervention to assist with goals of care and symptom management in collaboration with a private community oncology practice among patients with advanced cancer. This randomized controlled trial evaluates the effect of the intervention on acute care use and secondarily on goals of care documentation and patient satisfaction. Methods: Newly diagnosed patients with advanced stages of solid and hematologic malignancies were randomized from 8/11/2016 through 6/5/2019 into the intervention and control groups. All patients were followed for 12 months or death, whichever was first. Patients reported satisfaction with care using the Consumer Assessment of Healthcare Providers and Systems survey at time of enrollment and 9 months follow-up. We compared risk of death using Cox Models and compared rates of acute care, palliative care and hospice use using generalized models adjusted for length of follow-up. Results: A total of 104 patients were randomized with 52 in the intervention and 52 in the control. In both groups, the mean age was 67 years; 70% were non-Hispanic white, 25% Asian Pacific Islander, 1% Native Hawaiian, 1% American Indian/Alaskan Native, 3% multiple races/ethnicities. There were no differences in cancer diagnoses or stages. There were no differences in rates of survival between the two groups. Intervention patients as compared to the control had lower mean emergency department visits (0.80 +/- 0.17 versus 1.9 +/- 0.46, p = 0.02) and hospitalizations (0.67 +/- 0.19 versus 1.49 +/- 0.37, p = 0.04), greater rates of goals of care documentation (92% versus 33% p = 0.002) and no differences in palliative care (88% versus 77% p = 0.16) or hospice use (27% versus 21% p = 0.45). At 9 months follow-up as compared to baseline, patients in the intervention experienced greater improvements in satisfaction with their care (difference-in-difference: 0.41, 95% CI 0.22-0.60, p < 0.001). Conclusions: An LHW intervention significantly reduced acute care use and improved patient experiences with cancer care as compared to a control group. This intervention may be a solution to improve care delivery and experiences for patients after a diagnosis of cancer in community oncology settings. Clinical trial information: NCT03154190 .
Improving patient outcomes with oncology hospital at home: A program model.
Authors: Titchener Karen Alexandra , Coombs Lorinda A , Shepherd Shannon , Ward John Harris , Ameloot Karen , Dumas Kimberly , Beck Anna Catherine , Mooney Kathi 
Published: October 2020

5 Background: Hospital at Home provides acute hospital level care to patients in their homes, diminishing the need for inpatient care or emergency department (ED) use. It has been evaluated for a variety of acute and chronic conditions but not in adult oncology. Results from program evaluations have demonstrated equivalent or improved outcomes with lower health care utilization and costs and high patient satisfaction when compared to usual care. The first evaluation of an oncology Hospital at Home program in the United States, Huntsman at Home (HH) was launched in 2018 to provide acute level care after hospitalization and address emergent symptoms that arise in the home between clinic visits. We describe the structure and patient profile of HH over the first 15 months of service. Methods: We compiled data for the 169 cancer patients admitted to HH between 8/2018 and 10/2019. We examined patient characteristics, the reason for referral, team structure, services provided and provider visit pattern. Results: The 169 patients referred to HH were predominately female (62%), white (83%), with metastatic disease (79%) and an average age 62 years. The most common diagnoses were GI, lung, GU and GYN cancer. All required acute level medical care and were referred by their oncology or inpatient provider after hospitalization. The HH multidisciplinary team was led by 9 nurse practitioners (NP) partnering with palliative care hospitalists, and the patient’s oncology team. Registered nurses (RN) and other home health personnel were provided by a community-based home health agency. The most common reasons for referral were acute pain, dehydration and electrolyte imbalance, infection, unstable symptoms, failure to thrive and post-surgical needs. The most common interventions provided by HH were: assessment and management of symptoms, medication monitoring and titration, monitoring lab chemistries, intravenous management and administration of medications and fluids, and wound, drain and line assessment and care. Home visits varied based on need; generally, there were 3 NP visits with 5 RN visits in the first week. Health care utilization and cost outcomes were recently reported at the ASCO Virtual Scientific meeting and demonstrated HH patients had fewer hospitalizations, shorter length of stay, decreased ED use and lower costs than the comparison group. Conclusions: HH has proven to be an effective and efficient way to successfully manage a variety of oncology acute care needs in patients’ homes averting further hospitalization or ED use. Hospital at home shows promise as an oncology care delivery model.
Effects of COVID-19 on an academic breast oncology center in New York City.
Authors: Prigoff Jake , Hillyer Grace , Bell Fletcher , Accordino Melissa Kate 
Published: October 2020

51 Background: The influx of patients to the healthcare system due to COVID-19 impacted healthcare practices including the care of breast cancer patients. Our aim is to describe the impact this pandemic had on breast cancer care delivery at an academic center in NYC to inform policy and procedure for future crises that limit patient access to on-site facilities. Methods: A survey was sent to physicians involved in the care of patients with breast cancer at Columbia University Irving Medical Center in May 2020. Participants were asked about practice structure and changes to breast cancer care. The primary outcome was the degree that providers believed breast oncology patients’ clinical outcomes were significantly impacted by COVID-19. Secondary outcomes included changes in diagnostic and management approaches and advice for future providers faced with a similar pandemic. Results: The response rate was 65.4% (17/26). This included physicians from medical oncology (n = 7), radiology (n = 4), breast surgery (n = 3), radiation oncology (n = 2), and plastic surgery (n = 1). Seventy-six percent of physicians somewhat agreed, agreed, or strongly agreed that oncologic outcomes may be significantly impacted by the COVID-19 pandemic. Nearly half (47%) of respondents reported delays in the workup of patients due to COVID-19 with 50.0% for mammograms, 47.5% for bone scans, 46.0% for ultrasounds, 43.8% for PET scans, and 43.3% for biopsies. Eighty-two percent reported delays in overall oncologic management. Delays to systemic therapy were: intravenous/targeted therapy (37.9%), intramuscular/subcutaneous endocrine therapy (28.3%), oral chemotherapy/targeted therapy (22.9%), and oral endocrine therapy (12.8%). Delays to local therapy were: surgery (64.4%) and radiation therapy (44.6%). Almost two-thirds (64.7%) reported it necessary to use alternative oncologic management strategies. The most common piece of advice our providers offered was to increase testing capacity to all patients, especially when coming to a healthcare facility. Conclusions: The COVID-19 pandemic has caused major disruption to breast cancer practices. Breast oncology physicians reported delays in management in over 80% of patients, and the need to use alternative management strategies in over 60% of patients. Effects of these disruptions on oncologic outcomes are unknown, but over 75% of our physicians believe this will significantly impact breast oncology patients’ outcomes. There's a need for policies and procedures to structure patient care should there be a future crisis that limits patient access to oncologic care.
Geriatric assessment-driven interventions among hospitalized older adults with cancer (GAIN-HOSP): A prospective pilot study.
Authors: Chien Leana , Sun Can-Lan , Kim Heeyoung , Uranga Carolina , Soto Perez De Celis Enrique , Burhenn Peggy , Charles Kemeberly , Vazquez Jessica , Roberts Elsa , Yu Wai (Kim) , Kim Jae Y. , Lau Clayton , Sentovich Stephen , Dorff Tanya B. , Sedrak Mina S. , Katheria Vani , Hurria Arti , Dale William , Li Daneng 
Published: October 2020

52 Background: Older adults with cancer often have age-associated vulnerabilities and challenges, especially during hospitalization. Geriatric assessment (GA) can help identify such vulnerabilities, generate recommendations, and guide the choice of interventions. Recently, GA-driven interventions have been shown to decrease chemotherapy toxicity among older adults with cancer in the outpatient setting. However, few studies have examined its role in the inpatient setting. Our purpose was to evaluate the feasibility of GA-driven interventions among hospitalized older adults with cancer. Methods: Hospitalized patients, age 75+, with a solid tumor malignancy were eligible. Each patient completed a GA while hospitalized at T1 (Timepoint 1) and one-month post discharge T2 (Timepoint 2). An Advanced Practice Nurse (APN) reviewed the T1 GA, provided targeted care utilizing GA results and implemented interventions based on predefined triggers built into the GA’s various domains. An APN also completed follow-up visits by phone at 1 week and 1 month post discharge. The primary outcome was feasibility, defined as the percentage of participants who received GA-guided interventions and was pre-specified as successful if > 80% were given recommendations. A secondary outcome of the study was to capture unplanned readmissions within 1 month post discharge. Results: Between 9/19/2017 and 5/3/2019, 49 patients were eligible and 40 were enrolled, an 82% participation rate. The median age was 80.5 years (range 75-88), 58% male, 63% Non-Hispanic white, 18% Hispanic, 15% Asian, 70% > a high school education, 73% married/partner, and 48% had stage IV cancer. Most common cancer types: GI (28%), GU (23%), lung (20%). All 40 patients (100%) had ≥ 1 predefined trigger in the GA generating interventions and completed ≥ 2 follow-up visits with the APN. In total, 857 interventions were recommended, and the mean number of interventions generated per patient was 11. The top 4 interventions were Occupational Therapy/Physical Therapy (n = 66), Social Work (n = 52), Nutrition (n = 39), and Pharmacy (n = 36). Overall 89% of GA-guided interventions were implemented. Unplanned hospital readmission was low with only one patient readmitted within 30 days (3%). Conclusions: Among hospitalized adults over age 75 with cancer, using GA to identify vulnerability, and provide GA-driven multidisciplinary interventions is feasible. Further studies are warranted to examine the impact of GA-driven interventions on outcomes among hospitalized older adults with cancer.