bluuebunny/crossref_metadata_2025_split huggingface dataset:
How effective is telephonic case management of cancer patients undergoing active therapy?
Authors: Wu Charlotte , Bannister Wade M , Chan Hungching , Schumacker Pam , Rosen Michael W , Blair Kelly L , Rossof Arthur H 
Published: March 2020

e17519 Background: The Cancer Support Program (CSP) of Optum provides patients and their caregivers with telephonic case management by experienced oncology nurses, social workers and appropriately-trained physicians. Goals include reducing emergency department visits and hospitalizations, and helping patients comply with treatments and more effectively manage symptoms. The intent of this study is to evaluate the effectiveness of CSP from both quality and financial perspectives. Methods: The study used a case control approach to compare participants and non-participants of the Optum CSP program. Propensity score method was applied to adjust for baseline differences between the two groups. The study population consisted of cancer patients (N=8,833) enrolled in commercial health plans through self-insured employers. The patients were referred into CSP between July 2009 and June 2011. Outcomes of cost and hospice days were estimated with generalized linear models. We also compared the group of CSP participants (N=3,716) to active cancer patients enrolled in a general CM program (N=2,867) on the topics the nurses discussed with patients. Results: For program participants who were under active treatment and survived at least 6 months after referral , medical cost per patient per month during the six month of engagement was reduced by 9.8% (95% confidence interval [3.7%, 15.6%], p-value 0.002). The decedent’s cost during the last 3 months of the life was reduced by 19.9% (95% confidence interval [2.8%, 34.1%], p-value 0.025). Average hospice days of all deceased CSP participants increased by 42.3%, (95% confidence interval [13.9%, 77.8%], p-value 0.002). CSP nurses, all of whom had cancer management experience, addressed 56 topics of cancer-related support compared to only 11 for general CM nurses. Among the topics that both groups addressed, 35% of the topics were addressed 10% or more frequently by CSP nurses, including “Cancer Treatment Choices Outlined” and “Education Provided: Cancer Medications” etc. Conclusions: We conclude the Optum CSP program is effective in reducing medical cost, promoting use of hospice and providing cancer-specific patient support for a population of cancer patients under active treatment.
The cost of treatment-related adverse events in metastatic breast cancer therapy: Taxanes versus capecitabine.
Authors: Hansen Ryan N , Brammer Melissa G. , Ramsey Scott David , Lalla Deepa , Hurvitz Sara A. , Sullivan Sean D 
Published: March 2020

e17527 Background: Over 73,000 women annually experience new or recurrent metastatic breast cancer (mBC) in the U.S. Chemotherapy can prolong survival with mBC but adverse events (AEs) from chemotherapy are common, costly to manage and may lead to changes in clinical outcomes. We evaluated the difference in cost of treatment for taxane- (TAX) and capecitabine-based (CAP) treatments for mBC patients in the U.S. focusing on the incremental impact of AEs on the cost of care. Methods: A cohort of mBC patients diagnosed from 2008-2011 was identified from the Truven Marketscan® Database. Patients were grouped into chemotherapy categories of either TAX (paclitaxel or docetaxel) or CAP using claims data. Common chemo-related AEs were identified by ICD-9 codes. Healthcare costs were tabulated from a payer perspective, adjusted to 2011 U.S. dollars. To control for selection bias, propensity scores for treatment selection were calculated using age, diagnosis, health plan type, and renal or hepatic insufficiency as predictors. Generalized linear models estimated the cost of treatment by medication type and the presence/absence of AEs. Results: From 52 million subjects, we identified 13,474 mBC patients that met inclusion criteria. We identified 11,902 patients treated with TAX and 1,572 treated with CAP. At least one AE was experienced by 69% (S.D. = 0.46) of TAX users and 56% (S.D. = 0.50) of CAP users. The most common AEs were infection (39%), neutropenia (27%), and anemia (20%) for TAX users. CAP users most commonly experienced infection (36%), anemia (11%), and dyspnea (11%). Average incremental monthly costs were $3,082 and $6,793 for TAX and CAP patients with an AE compared to those who did not experience an AE, respectively. Costs increased by $1,358 for patients with 1-2 AEs (p=0.0002), $2,433 for 3-4 AEs (p<0.0001), and $5,294 for 5+ AEs (p<0.0001). Conclusions: Among community-treated patients, AEs are common in women with mBC receiving TAX and CAP based chemotherapy regimens. Persons experiencing these AEs have substantially higher healthcare costs which increase with the number of AE’s reported. Better management of AEs may represent an opportunity to significantly reduce costs and improve outcomes for women with mBC.
Factors affecting time to seeking medical advice and start of treatment in breast cancer (BC) patients in Turkey.
Authors: Ozmen Vahit , Boylu Sukru , Ok Engin , Canturk Zafer , Celik Varol , Kapkac Murat , Girgin Sadullah , Tireli Mustafa , Ihtiyar Enver , Demircan Orhan , Baskan Mazhar Semih , Koyuncu Ayhan , Tasdelen Ismet , Dumanli Esra , Ozdener Fatih 
Published: March 2020

e17529 Background: One of the most important reasons of BC mortality is delay in treatment. Due to lack of BC awareness and organized screening programs, total delay time (from first symptoms of BC to initiation of treatment; TDT) is longer in low-middle income countries. The primary goal of this survey was to identify factors affecting TDT in patients with BC. Methods: As a part of previously presented multinational survey, a total of 1.031 BC patients from 12 cities of 5 districts in Turkey were surveyed using a uniform questionnaire. TDT was determined using 8 individual scales, including one pertaining to patient delay and 7 related to subsequent steps in a typical diagnostic process. Regression models were constructed using 17 variables concerning diverse contextual and personal patient characteristics. Time between first symptom and first medical visit (Patient Delay Time; PDT) and time between first medical visit and start of therapy (System Delay Time; SDT) were modeled separately with multilevel regression. Results: Mean PDT, SDT and TDT were 4.8, 10.5 and 13.8 weeks respectively, with 42% of the patients with a delay of >12 weeks. Multilevel regression equation indicated that disregard of discovered symptoms (p<0.001) and having at least secondary level of education (p=0.021) were significantly correlated with longer PDT. Patients with stronger self-examination habits (p=0.009), reporting more support from friends and family (p<0.001) and living in metropolitan areas (>500k) (p=0.006) had shorter PDT. Predictors of longer SDT included disregard (p<0.001) and having a PDT>4 weeks (p<0.001). Shorter SDT was correlated to being older than 60 years of age (p=0.027). Results revealed that diagnosis during periodic check-up or opportunistic mammography vs. symptomatic BC (p<0.001) and having first medical examination by a surgeon resulted in shorter SDT. Conclusions: TDT in Turkey is unacceptably long and system delay accounted for a substantial part of the total delay experienced by breast cancer patients. This points to a need for shortening clinical pathways if possible. A long patient delay calls for research into patient awareness of BC.
Past medical history (PMH) in oncology: Which is the best source, the doctor or the patient? A prospective double blind study.
Authors: Montiel Monica , Garcia Gerardi Carlos Fernando , Gil Deza Ernesto , Morgenfeld Eduardo L. , Martin Reinas Gaston , Rivarola Edgardo G. J. , Gercovich Felipe G. 
Published: March 2020

e17539 Background: The usual way in which Argentinean doctors (Dr) register a patient’s (Pt) PMH in the Clinical record (CR) is the anamnesis. It has proved to be quite heterogeneous. At the Instituto Oncológico Henry Moore (IOHM) a PMH form was designed to be filled out by the Pt before the interview. The objective of this paper is to compare and contrast the amount and quality of PMH information registered by Pt and Dr through a double blind study in order to assess the usefulness of the PMH form. Methods: Between Dec 13th and Dec 20th, 2012, data was collected from all new Pt assisted at the IOHM. In the case that the PMH registered a severe pre-existing condition that was not present in the CR, the physician in charge was made aware of this fact. By indication of the IRB, an interim analysis had to be carried out a week after the study had begun. If the quantity of information proved to be 25% greater or the quality proved to be 5% greater in favor of Pt, the study should be finished. Results: A total of 73 P were included in a prospective double blind study. Sex: 42 males/31 females; Mean age 58.7y (range 21-88); Tumor diagnosis: urological 24, gynecological 17, gastrointestinal 11, other 21. PMH forms filled out by Pt showed 878 pre-existing medical conditions: mean 12 (range 1-35); the CR filled out by Dr showed 453 pre-existing medical conditions: mean 6 (range 0-21). In 3 CR, Dr registered data that Pt had not. A total of 67 CR (92%) showed less data than the PMH, Mean 6 (range 1-21). Quality analysis demonstrated that 15% of the unregistered data could be relevant in medical decisions. Due to the overwhelming differences between registries, the study was finished and the Pt´s PMH form was included as part of the CR at the IOHM. Conclusions: 1) The quality and quantity of data acquired by using the PMH form far exceeds that of the data registered by doctors in CR. 2) In 15% of all the cases, this information could be relevant in medical decision making. 3) In only 3 cases, doctors registered more data than patients using the PMH form. 4) A form filled out by the patient and reviewed by the doctors could be a significant tool on preventing malpractice.
Adherence and patients’ attitude toward oral anticancer drugs: A prospective series of 226 patients focusing onto targeted therapies.
Authors: Barthelemy Philippe , Dourthe Louis-Marie , Serra Sebastian , Asmane-De la Porte Irene , Prim Nathalie , Ame Shanti , Litique Valere , Giron Cathy , Goldbarg Veronica , Fornecker Luc , Duclos Brigitte , Kurtz Jean Emmanuel 
Published: March 2020

e17543 Background: Patients’ adherence has been identified as a challenge in oncology and hematology practice. Hormone therapy data in breast cancer suggest insufficient adherence and poor persistence. Limited data is available for targeted therapies such as tyrosine kinase (TK) and mTOR inhibitors whereas poor adherence to TK treatment was linked to treatment failure in GIST and CML. Methods: We report the result of a prospective survey in 226 patients (pts), with solid tumors and hematologic malignancies receiving oral anticancer therapy including chemotherapy or hormone therapy (CT), and targeted therapies (TT). Treatment duration and setting (adjuvant vs metastatic), cancer type, age, co-medication were analyzed. Patients were given a 15-item questionnaire and asked to anonymously answer questions regarding their attitude towards oral anticancer drugs. To analyze adherence, patients were asked whether they voluntarily or not missed any drug dosing during the last month. Results: 226 patients (median age 65.5 y.o) participated, 115 with TT and 111 with CT, with a median time of drug intake of 10.5 months. Both TT and CT patients stated to be well informed about treatment modalities in (92%), mostly by their oncologist or hematologist (87%). Written information was more frequently given in TT pts (67.0 vs 27.0%, p<0.0001). TT pts declared to be more often fully adherent to therapy (84.3 vs 66.7%, p=0.01) despite experiencing more side-effects (p<0.0001) and taking more concomitant oral medication (p=0.029). The mean treatment duration was 28.0 vs 20.3 months in TT vs CT pts (NS), but in both groups non-adherence was observed at any time since initial prescription. Conclusions: Despite advances in patients’ information leading to better treatment adherence in TT pts, efforts are still warranted such as the onset of dedicated staff for early and prolonged monitoring of outpatient anticancer oral therapy.
Economic growth of BRIC nations and access to early-phase oncology clinical trials: An overview.
Authors: Rodrigues Heloisa Veasey , Ganesan Prasanth , Liu Xiaochun , Subbiah Vivek 
Published: March 2020

e17554 Background: With increasing globalization we have witnessed exponential economic growth in the BRIC (Brazil, Russia, India and China) nations. Concurrently, clinical trials have been outsourced to these countries. We sought to investigate the current status of early phase oncology clinical trials in the BRIC countries, exemplifying the impact of these emerging economies and global markets in health care. Methods: We reviewed the clinicaltrials.gov database for registered early phase trials (Phase I/II) in the BRIC countries; 2. We looked at research from these countries collectively. 3. We reviewed specific challenges and prognosticated the road ahead through a literature review. Results: We identified374 active early phase clinical trials in BRIC countries as of October 2012. China had 68% (255/374) of the trials, Brazil 14% (51/374), Russia 12% (47/374) and India 6% (21/374). Twenty-three trials were registered in more than one BRIC; therefore we analyzed 348 different trials. Gastrointestinal (20%, 70/348), lung (19%, 67/348) and breast (17%, 57/348) cancers were the most studied. Most of the trials were sponsored by universities or hospitals (51%, 176/348) and most conducted in a single country (73%, 247/348) with 70% of therapy intended to be palliative (243/348). Combined agents were most commonly studied (57%, 199/348). Among the 217 targeted-agent trials, 23% targeted the EGFR pathway, 18% the VEGFR, 11% involved multi-tyrosine kinase inhibitors and 10% the PI3K-mTOR pathway. Funding mechanisms and sponsorship of studies were disparate. Industry-sponsored studies comprised 24% (62/255) in China, 96% (45/47) in Russia, 80% (41/51) in Brazil and 57% (12/21) in India. Conclusions: Despite theeconomic explosion and shift of non-oncology clinical trials to BRIC nations, USA and Europe still lead in conducting early phase clinical trials in oncology. China accounts for 19% of world’s population and has the majority (68%) of trials while India (17% of World’s population) has only 6%. A dominance of industry-sponsored studies in BRIC countries other than China was found. Significant challenges in infrastructure and trained personnel remain, but efforts to overcome them are underway.
Usability testing of the PRO-CTCAE measurement system in patients with cancer.
Authors: Fawzy Maria R. , Abernethy Amy Pickar , Schoen Martin W. , Rogak Lauren J. , Mendoza Tito R. , St. Germain Diane C. , Paul Diane B. , Baumgartner Paul , Gangoli Vinay , Chilukuri Ram , Mitchell Sandra A. , Reeve Bryce B. , Castro Kathleen M. , Shalley Eve , Basch Ethan M. 
Published: March 2020

e17560 Background: Use of electronic Patient-Reported Outcomes (ePROs) are increasingly employed in patient care and oncology research. However, these systems can be difficult to use, preventing adoption and deployment. The objective is to evaluate the patient usability of the National Cancer Institute’s (NCI) Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System. Methods: PRO-CTCAE is an item bank of 124 questions evaluating 78 symptomatic adverse events, as well as a software system that includes a web-based and interactive voice response system [IVRS] to administer these items to patients, and electronic features to customize survey creation, schedule survey administration, export data, and generate alerts and reports. A protocol was developed for two rounds of usability testing to evaluate understanding and ease of navigation reported by patients undergoing cancer treatment. Software was refined between rounds and retested. Patients were asked to login and complete PRO-CTCAE items either in clinic or at home, then were immediately debriefed (semi-scripted) by a trained interviewer. Results: 173 patients at 3 cancer centers and affiliated community network sites were enrolled in the study between 1/11-5/12 (45% male; 32% non-white; 26% high school or less). Usability issues identified in Round 1 (N=37) included difficulty in using radio buttons, absence of survey progress indicators, and problems with system login. Modifications included increasing size of buttons, improving the progress bar feature, and simplifying the interface to focus users on survey questions. In Round 2 (N=136), remaining issues were related to general difficulty with Internet use, such as navigating to the URL. IVRS testing indicated high scores of ease of use and completion of items, but users had difficulty adding unique symptoms to the system. Conclusions: Iterative usability testing identified improvements to web-based and IVRS for patient self-reporting and achieved a more favorable user experience. The feasibility of integrating PRO-CTCAE into trials to gather symptomatic adverse events directly from patients is currently being evaluated in the cancer cooperative groups.
Patient barriers to participation in clinical trials in a community cancer center.
Authors: Ramakrishnan Geethakumari Praveen , Ackler Joann R. , Gooptu Mahasweta , Braitman Leonard E , Tester William J. 
Published: March 2020

e17578 Background: Clinical trials are fundamental to research and innovative oncology treatment. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician and protocol levels. Methods: We conducted a descriptive cross-sectional study in a community cancer center serving a diverse patient population. A total of 160 eligible patients offered enrollment in various clinical trials from July 2010-December 2012 were included. A standardized questionnaire was delivered by mail or in person. Electronic medical records and patient charts were used for disease specific data. Acceptors and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Forty-nine patients (males: 9, females: 40) returned the questionnaire. Twenty-eight had accepted and 21 declined trial participation. Mean age of acceptors was 56.2 ± 2.2 compared to 63.96 ± 1.6 for decliners (p=0.007). Acceptance was highest for stage IV disease (85.71%) [p=0.077]. Of foreign-born patients, 71.4% patients were decliners [p=0.122]. Of those “comfortable with randomization,” 85.2% were acceptors compared to 22.7% who were not [p<0.001]. Of respondents encouraged by knowing that they could leave the study at any time and receive standard treatment, 79.4% were acceptors [p<0.001]. Of patients who valued trust in their doctor, 85.7% accepted compared to 19.05% who did not [p<0.001]. Among most important reasons for their decision, acceptors valued altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, depression and need for family support. Conclusions: Results confirm barriers among diverse patients treated in a community cancer center and suggest the type of patient likely to participate in clinical trials. Study limitations include small sample size and majority of female respondents. Key factors included age, patient’s insight into the conduct of randomized trials, perceived drug side effects and the doctor-patient bond. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.
Unescheduled visits in cancer patients treated in a clinical trials unit (CTU).
Authors: Gaba Lydia , Victoria Iván , Reig Óscar , Lopez Sandra , Gascon Pedro , Vidal Laura 
Published: March 2020

e17580 Background: A number of unscheduled visits may occur in addition to the predefined protocol-specific visit calendars in a CTU. The aim of this prospective study was to characterize and assesss the frequency, causes and the probable relationship of the emergencies with the investigational products (IPs). Methods: A consecutive sample of patients treated in a CTU who presented an urgent medical consultation from July 2012 to January 2013 was registered. Epidemiological data, characteristics of emergency visits and relationship with IPs were revised. Results: 141 patients were registered; 75 men (53.2%) and 66 women (46.8%) with a median age of 61.4 years. Most of them had metastatic cancer and 63 patients (44.7%) had been included in phase III clinical trials. Tumors which produced a higher number of events were melanoma (n=53, 37.6%), colorectal (n=24, 17%) and breast cancer (n=21, 14.9%). Those treatments associated with more unscheduled consultations were chemotherapy agents, Braf inhibitors and antiEGFR antibodies. Of those, 45.4% were in-person consultations, whereas the 54.6% were performed by phone. The main causes were pain (18.4%), diarrhea (12.1%), fever (12.1%) and skin symptoms (10.6%). 48.9% were related to an adverse event of the IPs. 78.7% of the consultations were oriented and specifically treated at the moment of the appointment, whereas the 21.3% had to be referred to another service. 36.2% of the unscheduled visits were directly related with the IPs. Of those, 30% were 3-4 graded. Conclusions: Patients treated on a clinical trial generated an elevated number of unescheduled visits and a significant percentage of them are related to the IPs. Most of them should be managed by staff with the appropriate knowledge and training.