bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II study for determining usefulness of FDG-PET as imaging biomarker in regorafenib treatment for metastatic colorectal cancer (JACCRO CC-12).
Authors: Nakamura Masato , Satake Hironaga , Tsuji Akihito , Sagawa Tamotsu , Takagane Akinori , Sekikawa Takashi , Ichikawa Wataru , Oguchi Kazuhiro , Kaji Tomohito , Kochi Mitsugu , Fujii Masashi , Takeuchi Masahiro , Nakajima Toshifusa 
Published: February 2017

TPS772 Background: Regorafenib (rego) is a novel multikinase inhibitor. A clinical, placebo-controlled phase III study (CORRECT) showed a 1.4-month improvement in Overall Survival (OS) as compared to the placebo group (HR 0.77, p = 0.0052) for metastatic colorectal cancer (mCRC). In the CORRECT trial, the Progression Free Survival (PFS) curve showed that half of the patients in the rego group showed a similar tendency to the placebo group. The finding suggested that patients might be divided into responders and non-responders, and there might be a biomarker to predict them. Although various studies including the CORRECT trial have searched for the biomarker of rego, it still has not been established. On the other hand, tumor metabolic analysis using FDG-PET has been reported to be more sensitive than the change of tumor size using CT to predict the response of molecular targeting therapies. We conducted a prospective multicenter phase II trial to identify the usefulness of FDG-PET as an imaging biomarker for rego. Methods: The main eligibility criteria are as follows; pathologically proven mCRC, sufficient organ functions, failure of standard therapies (fluorouracil, oxaliplatin, irinotecan and any biologic agents), with tumors detected by FDG-PET. The treatment schedule consists of 160mg once-daily oral administration of rego for 3 weeks, followed by 1 week of rest. On day 28, FDG-PET is re-taken and the change of the maximum standardized uptake value (SUVmax) from that of the pre-treatment examination is evaluated. The primary endpoint is the change of SUVmax in the region with the highest value in pretreatment FDG-PET. Secondary endpoints are changes of SUVmax in top 5 regions (maximum 2 regions in one organ), OS, PFS, response rate, disease control rate, adverse events, and correlation of their clinical parameters and changes of SUVmax. Because there has been no data about early change in SUVmax when rego was used, we set the threshold value and estimate value as 0% and 10%, respectively. Assuming a one-sided alpha of 2.5% and a power of ≥ 90%, 16 subjects are required, and a target sample size of 20 patients was determined. Ten of the planned 20 patients have been enrolled. Clinical trial information: UMIN000015563.
Cost comparison of treating low- and intermediate-risk endometrial cancer using time-derived, activity-based costing (TDABC) in a large regional cancer network delivery model.
Authors: Fleming Nicole D. , Lu Karen H. , Calhoun John D. , Jhingran Anuja , Arzu Isidora , Soliman Pamela T. 
Published: February 2017

9 Background: Value-based and quality health care delivery has become an important focus for many health care systems. The purpose of this study was to assess the cost differences in treating low and intermediate risk endometrial cancer using time-derived activity based costing (TDABC) in a large regional cancer network model. Methods: Process mapping and TDABC was performed in treating endometrial cancer patients at a large tertiary cancer center (main) with a regional cancer network program. Clinical visits and adjuvant therapy including high-dose rate vaginal cuff brachytherapy (VBT) and pelvic radiation (PRT) were performed in ambulatory treatment centers at each location. Surgery for endometrial cancer was performed at the main cancer center. Costs for each process point was determine by cost-capacity rates, and compared by treatment center location. Results: TDABC costing determined a 28.3% cost difference in ambulatory clinic visits for endometrial cancer patients, favoring treatment at the regional network location. There was no cost difference in surgery for endometrial cancer patients since all procedures were performed at main. Delivering adjuvant VBT was 44.2% more in the ambulatory regional center compared to main, primarily due to the radiation quality assurance checks at the regional site. TDABC costing determined a 39.8% cost difference in delivering PRT for intermediate risk endometrial cancer patients, favoring treatment at the regional network location. Overall, there was a 13.2% cost savings, favoring treatment at the regional cancer network location. Conclusions: Delivering care for low and intermediate risk endometrial cancer in a regional network model may represent a cost effective health care delivery method. Quality assurance checks at the regional locations are required for quality treatment delivery, however, may represent an area for cost effective process improvements or need to stratify treatment location based on complexity.
Establishing a value framework for cancer-specific patient satisfaction (PS) across a large health system.
Authors: Holcombe Randall F. , Cartwright Frances 
Published: February 2017

100 Background: The Mount Sinai Health System and the Tisch Cancer Institute (TCI) includes 7 hospitals and 6 ambulatory oncology centers in New York City, with over 9,000 new cancer cases seen annually. In order to address PS across these multiple sites, we established a framework to enhance value encompassing 4 domains: Infrastructure, Responsibility, Outcomes and Monitoring. Methods: Infrastructure. A quality dashboard was developed and distributed across all system sites. Inpatient oncology Dyads (D) (inpatient medical director and nurse manager) and ambulatory oncology Triads (T) (ambulatory medical director, nurse manager and administrator) and Quadrads (Q) (including radiation therapist) were established. Responsibility. DTQs at each location were given collective responsibility for PS performance. Outcomes. The relevant HCAHPS and Press-Ganey PS scores were defined across all groups; expectations for initiatives to improve PS were delineated. Monitoring. Each DTQ reported PS performance and progress on initiatives at a quarterly system-wide meeting of the TCI QI committee. Results: The quality dashboard provided a comprehensive PS report for all system sites and the DTQs identified specific individuals responsible for PS at each site. Within 6 months, establishment of the value framework more than doubled the number of quality initiatives, including ones focused on pain management, goals of care discussions and distress screening. Required participation in the TCI QI committee resulted in 100% compliance with reporting to a high level oversight group. Conclusions: The value framework involved the complete reorganization of how PS was reviewed, which individuals were responsible, and how initiatives to improve the patient experience were developed and monitored across the health system. Standardized dashboard-based reporting of PS facilitated review of critical information and creation of the DTQ structure facilitated engagement by key stakeholders, leading to numerous quality initiatives. Regular reporting elevated the level of attention ascribed to PS and the oversight group provided ongoing guidance for the process.
Development of an infusion nurse staffing model for outpatient chemotherapy centers.
Authors: Rodgers Georgina T. 
Published: February 2017

103 Background: Nursing roles and responsibilities within ambulatory oncology infusion suites across our health system are not clearly defined and it is not understood what the appropriate staffing ratio should be per site. It is not clear if employees are working to the highest level of their licensure or skill, and if the appropriate activities are performed by the correct department. A standard staffing model to provide efficiency of clinical services and patient safety does not exist, and nursing roles are variable between the sites. Similar patient populations are being treated at each site and the variability of the roles introduces unnecessary costs to the system as a whole. The purpose of this project was to define roles of the infusion nurse to insure performance to the highest level of licensure, create efficiencies within the clinical setting, potentially reduce RN staffing requirements, achieve a cost savings, and develop a target nurse to patient ratio while maintaining quality care. Methods: Daily patient volume and hours of operation were compiled for each outpatient site and three methodologies were used to determine nurse to patient ratio. We utilized an acuity based ratio tool, hours per unit (HPU) method using billed charges for technical procedures and finally a simple 1:6 ratio based upon patient volume. Each methodology showed similar results and a final target ratio of 1:6 was chosen. Results: A staffing template was created to predict the number of RN’s necessary for treatment and an analysis of infusion sites was also completed to observe workflows and determine potential staffing adjustments. Our pilot site was initially staffed with 14 RN FTE’s and analysis showed many non-clinical, non-nursing duties were being performed by RN’s. Through process improvement we have created clear role delineation and the site currently functions with 5 RN FTE’s. We have maximized the efficiency of the nursing team, reduced costs, and there has been no decline or compromise in quality or patient safety. Conclusions: The implications of establishing this standard for infusion nursing has allowed us to duplicate the methodology across the health system and achieve a level of staffing that matches well with patient care needs.
Feasibility, acceptability, and efficacy of a proactive telephone intervention to improve toxicity management during chemotherapy.
Authors: Krzyzanowska Monika K. , McKay Cassandra , Han Heekyung , Gandhi Sonal , Laferriere Nicole Beatrice , Atzema Clare , Chan Kelvin K. , Howell Doris , Kukreti Vishal , Leung Yvonne , Pardhan Aliya , Mitchell Sandy , Nayer Marla , Pasetka Mark , Yao Jane , Redwood Erin 
Published: February 2017

105 Background: Chemotherapy (chemo) is associated with a significant risk of toxicity, which often peaks between ambulatory visits. Consequently, effective remote symptom management support is essential to optimize self-management and resource use, including emergency department visits and hospitalizations (ED+H) during chemo. The aim of this study was to examine the feasibility, acceptability and effects of a telephone management intervention on symptomatic toxicity and resource use during chemo for early stage breast cancer (EBC). Methods: A prospective study of telephone-based toxicity management among women receiving neo-adjuvant or adjuvant chemo for EBC was undertaken at one urban and one rural site in Ontario, Canada. The intervention consisted of two standardized calls by nurses assessing common toxicities after each chemo (call 1 within 3 days and call 2 within 8-10 days). Primary outcome measures were feasibility and acceptability based on patient (pt) and clinician feedback. Efficacy was evaluated by self-reported ED+H. Results: Between 09/2013 and 12/2014, 77 women with EBC were enrolled (mean age 55 years). Most commonly used regimens were AC-paclitaxel (58%) and FEC-docetaxel (16%). 78% of pts received primary GCSF prophylaxis. Adherence with calls was 82%; mean call duration was 9 minutes. The intervention was well received by both pts and clinicians. 97% of pts indicated they liked receiving the calls and 94% would recommend this protocol be offered to all pts receiving chemo. Clinicians and pts felt the calls reduced pt anxiety by providing just-in-time education and counselling. Twenty five (33%) pts reported at least one ED+H during chemo, lower than the historical rate of 44% for this population in Ontario. Challenges included introducing an intervention that involved both routine clinical personnel and research staff and incorporating the calls into existing work responsibilities. Conclusions: Telephone-based toxicity management during ESB chemo is feasible, perceived as valuable by clinicians and pts, and may be associated with lower rates of acute care use. Larger scale evaluations of this approach focusing on effectiveness are warranted.
Using a disease pathway management approach to improve the quality of breast cancer care in Ontario.
Authors: Eisen Andrea , Soobrian Jasmin , Tyrrell Ashley , Li Clement , Muradali Derek , Forbes Margaret F , Gollnow Angelika , Ross Jillian , Holloway Claire ,   Cancer Care Ontario (CCO) Breast Cancer Pathway Working Group
Published: February 2017

109 Background: Disease Pathway Management (DPM) is used by Cancer Care Ontario (CCO) to set priorities for cancer control, plan cancer services, and improve the quality of care in Ontario by promoting standardization. The DPM approach applies a framework to examine the performance of the entire system from prevention to end of life care, and to identify any gaps within the system. In 2014, DPM began its breast cancer pathway initiative by mapping the patient journey, depicting evidence-based best practice along the breast cancer care continuum, identifying where further guidance is needed for clinical decision making, and identifying gaps in quality of care and performance measurement indicators. Objective: To evaluate the impact of DPM on quality assessment of breast cancer care in Ontario. Methods: DPM convened a multidisciplinary breast cancer working group (WG) of 40 experts from across Ontario. The WG held 12 meetings and used guidelines developed by CCO’s Program in Evidence Based Care (or other sources as needed) to generate pathways for the prevention, screening and diagnosis, treatment, and follow-up care for breast cancer. The pathways were used as a framework to review the existing inventory of provincial breast cancer quality indicators, and to identify areas where evidence based guidance is needed. The pathways were subjected to an extensive review process before publication. Results: The expert WG identified 28 priority areas, including opportunities to develop guidance in areas where it is lacking (e.g. role of perioperative breast MRI; indications for contralateral prophylactic mastectomy) and system barriers that may hinder optimal care (e.g. biomarker assessment). The WG also used the pathways as a framework for evaluating performance measurement indicators by mapping 48 existing quality indicators for breast cancer to the pathway. Conclusions: The CCO DPM Breast Cancer pathways facilitated a province-wide, multidisciplinary process to promote quality standards, to identify gaps and overlaps in performance and quality measurement, and to recommend additional indicators more relevant to the quality of breast cancer care in Ontario.
A multidisciplinary quality improvement project to improve the safety of oral chemotherapy in hospitalized patients.
Authors: Sica R. Alejandro , Sidani Amer , Domingo Gelenis Calzadilla , Sullivan Diana , Sencion Katherine , Ho Dominic , Haaf Christina , Bursua Adam , Venepalli Neeta K. 
Published: February 2017

110 Background: At the University of Illinois Hospital and Health Sciences System (UIC), inpatient IV chemotherapy administration occurs in the setting of specific protocols and multidisciplinary safety assessments while oral chemotherapy agent (OCA) inpatient administration occurs less formally. Baseline 8 week review of 174 admissions to the oncology service revealed that of 16 patients (9.2%) on outpatient OCA, 50% received OCAs while inpatient, with 12. 55% having a formal chemotherapy note in place. We aimed to increase the percentage of administered OCAs with associated provider generated chemotherapy notes from 12.5% to 75% over 16 weeks. Methods: A multidisciplinary task force comprised of oncology providers, clinical pharmacy, nursing leadership, and information technology was assembled. An actual and ideal process map was created, and using tools such as affinity sorting and root cause analysis, interventions were implemented focusing on residents (knowledge of OCA), nurses (documentation and policy adherence), pharmacists (education, policy adherence) and IT team (order modification). A standardized multidisciplinary hospital wide process was implemented for OCA ordering, administration, documentation, and patient education. A novel REDCap (research electronic data capture) auditing procedure was designed by which a weekly pharmacy report of every oral chemotherapy order at UI Health is automatically generated. Results: Between June and September 2015, a total of 67 OCA administration reports were audited. OCA notes were associated with OCA administration in 58% of cases in June, 100% in July, 78% in August and 93% in September. Furthermore, OCA notes were entered within 4 hours of OCA ordering in 58% of cases in June, 54% in July and 78% of the cases in August and September. No adverse events were reported. Conclusions: At the University of Illinois Hospital and Health Sciences System, a multidisciplinary team designed and implemented a standardized OCA administration, ordering, and documentation process focused on safe, appropriate and timely inpatient OCA administration. A novel REDCap auditing process assisted the team to identify the areas in need of optimization.
Clinical trial enrollment expansion to the community.
Authors: Kostka Judith , Zerillo Jessica A. , Kruse Andrea , Sinclair Natalie Faye , Patrick Maureen , McGovern Lauren , Fuller Frances , O'Neil Kelly , Hixon Nicole , Weeks Kristie , Johnson Bruce E. , Krop Ian E. , Savoie Jen , Daftary Farah , Constantine Michael , Kaddis Mona S. , Rossi Humberto A. , Tahir Naeem , Norden Andrew David 
Published: February 2017

112 Background: Oncology patients at community cancer practices generally do not access clinical trials to the same degree as patients at academic medical centers. Collaborations between research and clinical teams across academic hospitals and their affiliated community sites may help to improve this disparity. Methods: To improve clinical trial enrollment, a multidisciplinary team of research and clinical staff from the Dana-Farber Cancer Institute main campus and a community-based satellite site implemented a program to enhance identification of breast cancer patients eligible for clinical trials. The team constructed a process map, cause and effect diagram and collected diagnostic data, which was displayed with a Pareto chart. Process control charts were used to track data over time. Interventions included: (1) a web-based tool to pre-screen patients for community and main campus trials, (2) a training session for clinicians on trial communication skills, (3) designated clinician visits for follow-up trial discussions, and (4) research nurse telephone calls after the initial consultation. Results: Before the program (7/14-10/14), research staff screened 83% of new breast cancer patients for clinical trials, which increased to 97% after the program (11/14-9/15) (p < 0.001). There was not a significant change in trials presented to eligible patients or enrollment in trials. Conclusions: The proportion of patients identified for clinical trials increased and there was numeric improvement in the proportion of eligible patients presented trials. There was an increase in clinical trial enrollment that did not reach statistical significance, possibly due to the low sample size. These results suggest that the interventions would benefit from further modification and use. The project demonstrates the challenges and opportunities inherent in growing successful clinical trial programs in community-based satellite sites. [Table: see text]
Developing a one-team approach to meet three infusion centers’ staffing needs.
Authors: Winkelbauer Laurie , Stull Ellie , Yager Ann 
Published: February 2017

116 Background: Our cancer service line provides infusion services for oncology patients at three locations. The numbers of chairs vary by location from 10 to 30. Each location has a nurse manager. Staff are hired for specific locations. Hours of operation differ at each location, depending on patient needs. With increasing pressure to streamline operations and maintain productivity, along with challenges of RN vacancies and growing volumes, efforts were needed to coordinate staffing between locations to ensure best utilization of resources. Methods: The leadership team met to identify opportunities for improvement and develop an action plan. Issues identified included: Locations worked in silos to manage staffing issues and patient volumes. Decisions were made without consideration of the other locations; Staff were reluctant to float; Lack of consistent communication and comradery among managers/leads; Critical decisions were made inconsistently by staff; Lack of communication to senior management and physician leadership when capacity and staffing situations were occurring. Strategies were proposed to address the issues. Phone huddles with leadership from all locations are held daily to discuss staffing, patient scheduling and concerns. A tool was developed to assist with decision making related to staffing and patient scheduling. A “One Team” approach was implemented for staffing with the expectation that staff would float to cover staffing needs at the other locations. Processes were standardized across all units to ensure staff feel competent when floating. Results: Several positive outcomes have been noted since changes were implemented 10 months ago. Staff are more willing to float and have bought into the “One Team” concept. Cross coverage of staffing vacancies occurs daily, allowing for better and more cost effective utilization of staff across locations. Decisions to block schedules are made by managers using the developed tool. There is improved awareness of critical staffing and capacity issues by senior leadership and physician leaders. Conclusions: Implementing a One Team staffing approach to cover three infusion center locations increases staff productivity and allows for fluctuations in patient volumes.