bluuebunny/crossref_metadata_2025 huggingface dataset:
Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study
Authors: Apolo Andrea B. , Infante Jeffrey R. , Balmanoukian Ani , Patel Manish R. , Wang Ding , Kelly Karen , Mega Anthony E. , Britten Carolyn D. , Ravaud Alain , Mita Alain C. , Safran Howard , Stinchcombe Thomas E. , Srdanov Marko , Gelb Arnold B. , Schlichting Michael , Chin Kevin , Gulley James L.
Published: April 2017

Purpose

We assessed the safety and antitumor activity of avelumab, a fully human anti–programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma.

Methods

In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), progression-free survival, overall survival (OS), and PD-L1–associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells.

Results

Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1–positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%).

Conclusion

Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC.
A cost-utility analysis of sentinel lymph node mapping, selective lymphadenectomy, and routing lymphadenectomy in the management of low-risk endometrial cancer.
Authors: Suidan Rudy Sam , Sun Charlotte C. , Cantor Scott B. , Mariani Andrea , Soliman Pamela T. , Westin Shannon Neville , Lu Karen H. , Giordano Sharon Hermes , Meyer Larissa
Published: April 2017

10

Background: Our objective was to evaluate the cost-utility of 3 lymphadenectomy (LND) strategies in the treatment of low-risk endometrial cancer (EC). Methods: A decision analysis model compared 3 LND strategies in women undergoing minimally invasive surgery (MIS) for EC: 1) routine LND in all pts; 2) selective LND based on intraoperative frozen section, in which 60% of pts undergo LND; and 3) sentinel lymph node mapping (SLN) based on a published algorithm, in which 15% of pts map unilaterally (requiring a contralateral LND) and 5% don’t map (requiring bilateral LND). Costs and outcomes were obtained from published literature and Medicare reimbursement rates. Costs categories consisted of hospital, physician, operating room, pathology, and lymphedema treatment. Effectiveness was defined as 3-year disease-specific survival adjusted for the impact of lymphedema (utility = 0.8) on quality of life. Incremental cost-effectiveness ratios (ICERs) per quality-adjusted life years (QALYs) gained were calculated. QALYs and costs were discounted at an annual 3% rate. Results: For the estimated 40,000 women undergoing surgery for low-risk EC each year in the US, the annual cost of routine LND, selective LND, and SLN is $722 million, $681 million, and $656 million respectively. In the base case scenario, routine LND had a cost of $18,041 and an effectiveness of 2.79 QALYs. Selective LND had a cost of $17,036 and an effectiveness of 2.81 QALYs, while SLN had a cost of $16,401 and an effectiveness of 2.87 QALYs. With a difference of $1,005 and 0.02 QALYs, selective LND was both less costly and more effective than routine LND, dominating it. However, with the lowest cost and highest effectiveness, SLN dominated the other modalities and was the most cost-effective strategy. No ICER could be determined. These findings were robust to multiple one- and two-way sensitivity analyses varying the rates of lymphedema and LND, surgical approach (open or MIS), lymphedema utility, and costs. Conclusions: Compared to routine and selective LND, SLN had the lowest cost and highest quality-adjusted survival, making it the most cost-effective strategy in the management of low-risk EC.
A quality verification tool to assure complete pre-treatment electronic medical records (EMR) for patients undergoing radiation therapy.
Authors: Barnes Timothy , Harris Eleanor Elizabeth , Holloman Michael , Arastu Hyder Husain , Leinweber Clinton , Ju Andrew Wenhua , Naves James
Published: April 2017

103

Background: Complete medical records are critical for correct implementation of the intended care plan. Sentinel items include pathological reports, tumor staging, complete history and physical, pre-treatment performance and pain assessment, documented informed consent, and written directive/plan of care. The advent of electronic medical records and expanded use of technology have necessitated methodology to assure medical record completeness and quality. The technical portions of radiation oncology practice require unique EMR systems that are often used in addition to other institutional systems. The complete patient record is the aggregate of all systems. Methods: We developed a list of sentinel items that compose a complete pre-treatment radiation oncology medical record. This list was developed into an electronic spreadsheet and is recorded for each patient and his/her attending radiation oncologist. This tool is completed at the pre-treatment peer-review presentation and recorded for completeness and deficiencies. Any deficiencies were noted for resolution and tracked as a continuous quality improvement (CQI) activity to identify deficit root cause, interventions, and effectiveness of action(s). Results: Accumulative data showed the number and percentage of variances from standard practice as recorded at the time of initial peer review case presentation. Generally, the data showed improvement in completeness of the pre-treatment EMR by physician for the period February, 2015- November 2015. An initial 16% variance rate was recorded upon observation only in February of 2015. Variances over 5% were addressed and improvement programs instituted as needed. A final variance rate of 2.3% recorded in November 2015. Conclusions: Ongoing monitoring is an important strategy to assure complete pre-treatment medical records. The reasons for deficits are multi-factorial. Physician compliance and data availability, particularly for patients referred from outside facilities, were especially notable but resolution strategies have improved the system’s performance. These lessons will be part of the implementation plan for new EMRs over the upcoming months.
Survey of community pharmacists regarding their role and desire for managing chemotherapy related toxicities in cancer patients.
Authors: Vu Kathy , Santaera Daniella , Redwood Erin , Krzyzanowska Monika K.
Published: April 2017

104

Background: There is little published about the readiness and needs of community pharmacists to manage chemotherapy related toxicities in cancer patients. A survey was conducted to understand community pharmacists’ current toxicity management practices and their education and communication needs in this area. Methods: A 21 question electronic survey was sent to community pharmacists in Ontario, Canada from April 1 – June 30, 2016. The survey asked about demographics, toxicity management behaviours/preferences, communication and training needs/preferences. Results: Out of 559 responses received, 167 were excluded due to ineligibility giving a final response of 392 surveys. The majority of respondents were full time pharmacists practicing for more than 10 years in community pharmacy. While many pharmacists reported providing assessment (80%), advice (92%) and/or monitoring (70%) at least sometimes, few reported providing assessment (10%), monitoring (10%) or advice (18%) routinely. Types of toxicities encountered and their frequency are summarized in Table 1. There was a high level of interest (96%) among the respondents in being involved in assessing and managing chemotherapy toxicity, however, only 13% reported that they felt sufficiently trained to do so. Conclusions: Community pharmacists encounter chemotherapy-related toxicities in their daily work. While there is a strong interest in managing toxicity symptoms, many community pharmacists feel that they are not adequately trained to do so. Continuing education programs for this provider group may improve toxicity management in community pharmacy settings. [Table: see text]
Performing complex cancer surgery in the ambulatory setting.
Authors: Laudone Vincent Paul , Durany Robert , Ehdaie Behfar , Leitao Mario M. , Levine Marcia , Mehrara Babak , Patel Snehal G. , Scardino Peter T. , Sclafani Lisa M. , Sivaraman Arjun , Stein Daniel , Tseng Beverly , Twersky Rebecca , Simon Brett A
Published: April 2017

106

Background: The drive to move complex surgeries into the ambulatory setting will impact the cancer population. In anticipation, we developed an “ambulatory extended recovery” (AXR) program for pathway-based management of patients undergoing procedures with traditional 1-4 day hospital stays. Then in 2016 we opened the Josie Robertson Surgery Center (JR), a freestanding ambulatory surgical facility designed for complex cancer surgeries with one overnight stay. Methods: Using hospital databases we identified AXR cases eligible to be performed at JR and examined pathway completion (discharge home on POD 1), and 30-day institutional urgent care center (UCC) visits and readmissions. We compared AXR program results before and after opening JR in January 2016. Results: The most frequent AXR procedures were mastectomy ± immediate reconstruction, thyroidectomy, and minimally invasive prostatectomy, nephrectomy, and hysterectomy. 3307 and 2359 AXR procedures were done in 2015 and Jan-Sep 2016. In 2016 74% of AXR cases were performed at JR with the remainder at Memorial Hospital (MH), primarily for scheduling considerations or patient or surgical complexity. Pathway completion was 92% in 2015 and 95% in 2016 (p < 0.001). 30-day UCC visits/readmission rates were 8.8%/3.7% in 2015 and 8.6%/3.1% in 2016 (ns). Comparing cases at JR vs MH in 2016, pathway completion rates were 98.3% at JR vs 86.4% at MH (p < 0.001). Patient satisfaction was high for care provided at both facilities. Conclusions: Many complex cancer surgeries may be safely completed with a single overnight stay at a freestanding ambulatory facility. UCC visits and readmissions were not different between years, suggesting that quality of care was maintained in the ambulatory setting. The difference in pathway completion in 2016 at JR compared to MH may reflect successful triage of more medically complex patients and/or surgically complex procedures to MH.
Improving care coordination for brain tumor patients through value-based care redesign of a virtual integrated practice unit.
Authors: Nghiemphu Phioanh Leia , Dezelan Darlene , Tran Jackie H , Cloughesy Timothy Francis , Liau Linda M. , Ahn Christine , White Preston
Published: April 2017

110

Background: Brain tumor care at our institution involves providers from multiple departments in separate clinics and can cause patient frustration and poor patient experience. We previously reported on engaging care teams from Neurosurgery, Neuro-Oncology, Radiation Oncology, Neuroradiology and Neuropathology using lean methodology to re-design the care pathway for patients with brain tumors. A Patient Navigator Program was also established to help with patient’s care coordination. For this study, we evaluate whether this value-based care redesign has improved patient coordination and satisfaction. Methods: The care pathway and navigator process were implemented at the end of Dec 2015. We identified 202 patients who had brain tumor resections and were followed by our Navigator Program from July 2015 – Sept 2016. We evaluated the time from surgery to appointments and whether these appointments were all made within 1 week. We also reviewed our patient satisfaction scores using Press Ganey percentile ranks and HCAHPS metrics in the areas of patient education and coordination. We compared these data from July-Dec 2015 (pre-redesign) to data from Jan-Sep 2016 (post-redesign). Results: Of the patients followed by the Navigator Program, 137 patients required follow-up with providers from at least 2 different departments for treatment planning. Pre-redesign, the program followed 49 patients and made their appointments 14 median days from surgery (range 3-37), with 59% within 1 week. The 88 patients followed after-redesign had appointments in 16 median days (range 1-33) with 70% scheduled within 1 week. Pre-redesign, our Press Ganey Percentile rank ranged from 1st-32nd. After-redesign, the ranks increased to 16th-99th percentile, with most domains over the 80th percentile. Patients also reported higher satisfaction on HCAHPS post-redesign compared to pre-redesign. Conclusions: Development of a clear process for care coordination within the patient navigator program helped improve our patient satisfaction and streamline timely follow-up care. For our future coordination, we will implement a centralized access to care for our patients with brain tumors.
Incorporating medical marijuana in clinical practice.
Authors: Daleo Stephen James , Davis Matthew , Pham Trinh , Abdelghany Osama , Putnam Andrew , Lilenbaum Rogerio
Published: April 2017

117

Background: Medical marijuana (MM) is legal in the state of Connecticut. Regulatory issues, appropriate patient selection, and outcomes assessment have made it difficult for oncology centers to incorporate MM into clinical practice. At Smilow Cancer Hospital at Yale New Haven, a tertiary academic comprehensive cancer hospital, a multidisciplinary team was convened to propose guidelines. Based on the recommendations, the Smilow Cancer Hospital implemented a policy that outlines the use of MM in selected patients with nausea, anorexia and refractory pain. Here we describe the Smilow Experience with MM in clinical practice. Methods: Using health system-wide electronic medical record, a review of patients initiated on MM from 9/2015 to 10/2016 was conducted. Demographics, malignancy type/stage, MM indication, and preliminary data on formulation used and treatment outcomes were collected. Results: 108 cancer patients, majority evaluated by a Palliative Care physician, were initiated on MM (55.6% males/44.4% females). MM was prescribed more to patients with solid tumors compared to hematologic malignancies (91% versus 9%). The most common malignancy was gastrointestinal (34.3%), followed by lung (26.9%). Among patients with available definitive tumor staging, more had stage III or IV tumors (73.4%) compared to stage I or II tumors (26.6%). The most common indications are pain (81.8%) followed by cachexia (49.4%), and 40% of patients had more than one documented indication. Inhalation was the most common route of administration. Outcome data is limited at this juncture, though documentation indicates that more patients have reported “positive effects” from MM than “negative effects”. Conclusions: Despite legalization, the prescription of MM in cancer patients has been limited to individual practices, often outside of the context of a comprehensive cancer program. In these cases, follow up and outcomes assessment is minimal. Our review reveals that a health system-wide protocol allows patients to gain access to MM without having to leave the system. Our findings demonstrate interest among providers and patients in the potential therapeutic benefits of marijuana. Detailed data on efficacy and outcomes will be available at the time of the meeting.
The implementation of a lay care navigation service at the Stanford Cancer Institute.
Authors: Brown-Johnson Cati , Holdsworth Laura J , Rosenthal Eben , Asch Steve , Winget Marcy
Published: April 2017

119

Background: Lay care navigators address barriers to care, provide a single point of contact in complex health systems, and help efficiently resolve non-clinical patient issues. Despite navigation program proliferation, each is crafted to fit local institutional and patient needs. In Summer 2016, Stanford Cancer Institute (SCI) launched a care navigation pilot to improve patient engagement, facilitate better access to services, and improve coordination. The Stanford Care Navigator (SCN) program was based on a framework for lay navigation from the University of Alabama at Birmingham (UAB) who consulted on this project. This study describes the evolution of the SCN model and drivers of changes as SCN was iteratively designed and implemented. Methods: Qualitative study including document review of training materials, observation of cross-functional design meetings, stakeholder interviews, and a focus group with Care Navigators. Results: In spite of common goals of reducing patient distress and improving care coordination, the resulting SCN service is quite distinct from the consulting organization. Primary factors driving design changes were differences in: clinic access, patient populations and needs (e.g., SCN language translation needs vs. UAB poverty-related barriers), and a suite of pre-existing services at SCI (e.g. referral triage). Navigators call all new patients to address common barriers (traffic, parking vs. lack of transportation in Alabama). SCN refers some service items (e.g., financial support) to existing service groups, including Social Work. Conclusions: While Stanford navigation retains elements of the UAB-originating lay navigator program, in this radically different setting, service parameters differ substantially. The model was, therefore, substantially adapted rather than simply adopted. Ongoing evaluation explores navigators’ impact on patients and staff/providers.
Quality of care improvements resulting from a model of care that incorporates the primary clerk into the care team.
Authors: Cox Jennifer Anne , Hamm Caroline
Published: April 2017

122

Background: One common model of care within the oncology outpatient clinic setting is composed of the physician and primary nurse. We propose that the quality of care provided to oncology patients can be improved in this setting by incorporating the primary clerk into the care team, working in the same office space with the physician and nurse. Methods: Three care teams operating under the new model of care were observed during oncology outpatient clinics periodically from February 2016 to May 2016. The primary clerk’s interactions with the other team members were recorded, along with other tasks completed by the clerk that did not require team interactions but impacted quality of care. Data was later complied and organized into four domains that impacted the quality of care provided to patients. Results: The contributions to the care team by the primary clerk include improved clinic flow (e.g., ensuring treatment orders are inputted by the physician), patient convenience (e.g., identifying regularly scheduled blood work that is no longer necessary), patient safety (e.g., identifying patients scheduled for treatment with rituximab that have not had the required Hepatitis B & HIV screening), and hospital flow (e.g., preventing additional workload in the hospital laboratory by identifying when lab work can be combined in already scheduled appointments, and rescheduling clinic visits when results are not yet ready, which translates into time and cost savings to the hospital). Conclusions: As a result of the enhanced quality of care delivered, it is recommended that this model of care be adopted in the place of the traditional model, which lacks the essential element of interaction between the primary clerk and the rest of the care team.
Improving the quality of oncology fellows' clinical documentation.
Authors: Saha Debasmita , Tannenbaum Susan
Published: April 2017

124

Background: Proper documentation in oncology is a vital skill for fellows to learn. It not only allows for delivery of safe patient care by providing a mean for communication within providers, but it is also essential for coding and reimbursements, audits, research, quality/healthgrade scores and provides the the main body of medico-legal defense. From an educational perspective, it takes into account all 6 competences of medical education and hence is an integral part of fellowship training. The objective of this quality improvement project is to improve our fellows' documentation by ensuring they communicate timely and effectively a comprehensive care plan. Methods: We identified 10 random charts of patients who are actively being treated with systemic therapy by 4 of our senior fellows. The initial and a random follow up notes were reviewed and 34 areas thought to be of importance, specifically in oncology, were identified and logged. Verbal and written feedbacks were provided regarding their performances and areas of improvement, after which charts were re-evaluated in 6 months. Results: See table below. Conclusions: We successfully improved the fellows' documentation skills through this project, creating a better practice module. [Table: see text]
Using cancer registry data to improve adherence with breast cancer pathways.
Authors: Fields Karen K. , Watson Alicia , Durand Ashley , Simpson Tracy , Stewart Sandra , Shi JuQing , Liu Jack , Rollison Dana Elise
Published: April 2017

127

Background: Evidence-based clinical pathways have been shown to improve quality and cost effectiveness. Moffitt Cancer Center (MCC) has developed clinical pathways for more than 50 cancer sites. Using data derived from multiple sources, we performed a series of measurements of adherence to breast cancer (ca) pathways, provided clinician feedback and evaluated changes over time. Methods: We developed an automated method to evaluate pathway adherence for 1st line systemic treatment (tx) recommendations using data from Stages I-IV analytic breast ca cases presenting to MCC for tx during calendar years (CY) 2013-2015. As a baseline, cases were manually audited for adherence in CY 2012. Data sources included Cancer Registry and electronic health record (EHR). A patient (pt) was considered “On” pathway if the correct tx, including relevant clinical trials, was administered based on various prognostic and clinical factors. Only pts who received all 1st line systemic tx at MCC were included. Pts who refused txor had contraindications, non-applicable histologies or multiple primary cancers were excluded. The EHR was reviewed to assure the accuracy of “Off” pathway determinations. Results: A total of 3727 analytic breast ca cases were seen at MCC between CY 2012-2015; 873 met all criteria and were eligible for analysis. 80% was set as an institutional target for adherence. The following table displays yearly trends for pts “On Pathway” for all applicable chemotherapy, immunotherapy and hormonal tx. Conclusions: Cancer Registry and EHR data can be used to automate surveillance of pathway adherence creating a feedback loop to clinicians who can, in turn, improve adherence over time. [Table: see text]
Use of a secure mobile application to inform clinicians on adverse event management and drug-drug interactions for ribociclib: Experiences with CT scholar in ribociclib clinical trials.
Authors: Small Tania , Bugazia Najla , Nezami Brigette , Vinegra Michael , Fernandez Alberto , Dhuria Shyeilla V. , Feeley Jaclyn , Burroughs Lance
Published: April 2017

134

Background: Understanding and gaining familiarity with the adverse event (AE) and drug-drug interaction (DDI) potential of novel agents can be challenging, cumbersome, and time consuming for clinicians. A comprehensive and secure AE management/DDI mobile application (CT Scholar [Novartis Pharmaceuticals Corp]) was developed to ease the management of clinical trial participants with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer receiving ribociclib. Methods: CT Scholar was designed specifically for the ribociclib clinical program to provide easy access to information on AE and DDI management. The AE management module characterizes and quickly informs drug-specific AE management based on protocol guidelines and supportive care guidance. The DDI module includes a database of > 100 drugs searchable by both trade and generic name. Number of application visits, unique users, and screen views were monitored from Jan to Sept 2016. Results: There were 1055 visits to CT Scholar (117/month) by 145 unique users (28/month), with 5764 screen views (640/month) and 5.5 screens viewed/visit. Among the most-viewed modules were hematologic AE management (1132 views), gastrointestinal AE management (771), and DDI (734). Diarrhea, neutropenia, and nausea were the most viewed submodules (308, 230, and 205 views, respectively). The information on CT Scholar was consistently shown to be accessed more quickly than information obtained from printed clinical protocols. No patients discontinued from the ribociclib studies due to AEs following the introduction of CT Scholar. Conclusions: CT Scholar was widely used by clinicians, and it responded to their needs by providing essential information, especially on prevalent AEs, which could be easily updated and rapidly accessed. Additionally, CT Scholar provides a platform showing how technology can assist clinicians and patients in managing care during a trial, which can inform the development of future supportive materials.
Effect of physician-level performance feedback on pattern of structured cancer stage entry.
Authors: Pandya Chintan , Alongi Alex , Dougherty David W.
Published: April 2017

141

Background: In contrast to unstructured free text, structured entry of cancer type and stage facilitates easy utilization of this clinically important data to accurately identify patient population, measure and report performance on outcomes and quality of care as well as for various clinical decision support systems. There is significant variation in physician utilization of Electronic Medical Record based staging modules which capture the data in structured form. The aim of study is to increase structured cancer staging by providing performance feedback to individual physicians. Methods: An EPIC based physician performance feedback report was developed consisting of staging tool utilization performance captured by percentage of staged patients out of all the patients seen by the provider as well as the MRN link (to act upon) of the un-staged patients with stageable cancer diagnosis using criteria: 1) un-staged cancer on the problem list 2) active treatment plan and 3) seen by provider in last one year. Reports were sent monthly to the providers starting 11/1/2015. Pre-intervention structured staging rates were compared with 6- and 12-month post-intervention rates. Results: EPIC patient data was used to determine the number of patients eligible for staging. In 12 months prior to the intervention, 36% (n = 414/1164) of patients eligible for staging were staged in the structured staging module. After the intervention, the 6- and 12-month staging rates were 60% (n = 836/1387) and 68% (n = 1084/1585), respectively, suggesting an absolute improvement of 89% in structured stage entry. Conclusions: Performance feedback to oncology providers resulted in behavior change and dramatically improved rates of structured cancer staging. Availability of such structured data is essential for development, implementation and evaluation of various quality improvement interventions and strategies such as quality reporting, outcomes analysis, practice patterns, and other population health initiatives. Incremental and large-scale improvement in care processes and outcomes may be achieved through such individual-level feedback mechanisms and contribute to learning health care systems.
The patient experience: Patient characteristic differences in response.
Authors: Flaherty Stephen , Barysauskas Constance , Catalano Paul J.
Published: April 2017

144

Background: Understanding and addressing patient experience (PX) is an integral part of oncology care. The Press Ganey Outpatient Oncology instrument is used to better understand PX and performance differences at a large ambulatory oncology center. We investigated select patient characteristics of response among all eligible patients, the surveyed sample, and survey respondents. Methods: Over a six month period at a large ambulatory oncology center, 26,660 patients were eligible to report their PX. 11% of patients were identified following the center’s sampling criteria, of which Press Ganey applied their sampling strategy. Thus, 2,857 patients were randomly selected and sent the survey instrument, of which 828 patients responded. Patient characteristics of the three cohorts were compared across the center and by disease center. Results: Surveyed patients were a representative sample of eligible patients, as surveyed patients were of similar age (NS), gender (NS), education level (NS), and primary insurer (NS). In some dimensions, responders were not a representative sample of eligible/surveyed patients. Respondents were slightly older (p < 0.001), more often male (NS), more college educated (NS), and more frequently had a primary insurance of Medicare (p < 0.001). Similar population differences continued among eligible, surveyed and responders, in further comparisons by disease center. Conclusions: Population based sampling allowed the opportunity to investigate accuracy of the sampling strategy and the ability to identify a representative sample of patients across the oncology center. A comparison across the oncology center and disease centers revealed we cannot assume respondents are similar to the eligible and surveyed populations, thus we caution all assumptions made with unadjusted PX comparisons. Further research allows the opportunity to continuously update/improve the sampling strategy and administer electronic surveys to identify a more representative sample better positioned for future quality improvement opportunities. [Table: see text]
Validation of two cancer care plan communication tools.
Authors: Staunton Hannah , Yagnik Supriya , Williamson Nicola , Spencer Holly , Kaur Sharan , Bennett Bryan , Donelson Sarah , Jagun Dayo , Goertz Hans-Peter , Stein Alisha
Published: April 2017

145

Background: Patient-provider communication is recognized as allowing patients to become more active within the treatment process and treatment related decisions. This paradigm shift of involving patients as active stakeholders in their care promotes a patient-centered approach to healthcare, and may positively impact outcomes. Two tools for use in clinical practice were developed to aid patient-provider communication in oncology: Assessing Treatment Goals and Patient Education. This study aimed to evaluate the face and content validity of these tools. Methods: A non-interventional, cross-sectional, qualitative cognitive interview study was conducted in the US with patients with non-hodgkin’s lymphoma (n = 6), lung cancer (n = 7) and colon cancer (n = 7) and matched caregivers (n = 10). Interviews with oncologists (n = 5) and oncology nurses (n = 5) were also conducted. During the interviews, participants completed both tools as a ‘think-aloud’ process and were asked about the relevance and understanding of the instructions, questions, and response options, from the patient and healthcare provider perspective. Results: Ademographically and clinically diverse participant sample was recruited. Feedback from participants confirmed that the Assessing Treatment Goals tool questions were understood and considered relevant. Minor modifications were proposed including the addition of a question regarding the involvement of family and friends in healthcare decision-making. Similarly, the Patient Education tool topics were well understood and relevant. Minor modifications to simplify topic wording were proposed. Furthermore, the empirical data led to adding two topics: ‘body image’ and ‘beyond cancer care’. No topics were suggested for deletion from this tool. Patients and healthcare providers considered both tools to be valuable for communication. Conclusions: Feedback from participants supported the face and content validity of both tools with minor modifications. The next phase of research is to pilot the tools in clinical practice and assess for usability and feasibility. It is hoped that when used in clinical practice these tools will facilitate greater patient-provider communication and increased satisfaction with care.
The oncology prognosis and informed consent: Presentation of a new model to best inform patients.
Authors: Garmezy Benjamin , Blumenthal-Barby Jennifer
Published: April 2017

146

Background: Receiving a malignant diagnosis is challenging and patients must be properly informed of their prognosis to make the best decisions for themselves and their families. The general population has a low degree of statistical literacy and therefore approximations should be considered favorable. However, given that half of patients desire quantitative data, physicians must provide this information within a context that is relevant and comprehensible. Single-point median survival data is less meaningful for patient decision-making. What is preferable is that physicians give experience-based estimations on how a patient might compare to the ‘average’. Including this information leads to more informed consent and best follows the ethical principle of autonomy. Methods: This is a novel framework for providing a prognosis that builds upon the multiples-of-the-mean model established in 2010 by Kiely, Tattersall, and Stockler. This framework was derived from original ethics research involving patient preferences, statistical comprehension, healthcare communication, and medical decision-making. Results: Graphical representation of Kiely’s model provides an intelligible view of quantitative data and allows for the physician to include an experience-based estimation. Steps: (1) Draw a Horizontal line, (2) Calculate from median survival data by using five multiples: 0.25 (Worst-Case, 10% of patients), 0.5 (Lower-Typical, 25%), 1 (Median, 50%), 2 (Upper-Typical, 75%), and 3 (Best-Case, 90%), (3) Label the chart using simple time points in months or years (4) Draw a circle over the region that best represents the patient’s expectation, (5) Provide the diagram alongside easy-to-understand language that clarifies the meaning of the numerical data with written likelihood of the occurrence, such as “almost no chance”, “not likely”, “even chances”, “likely”, and “fairly confident”. Conclusions: Kiely’s model has proven an accurate estimation in colorectal, castration-resistant prostate, non-small-cell lung, and metastatic breast cancer. A graphical representation should provide physicians an easy tool to strengthen informed consent and better aid their patients in decision-making.
Oncologist preferences in advanced soft tissue sarcoma: A discrete choice experiment.
Authors: Hess Lisa M. , Ivanova Jasmina I , Horton Viviana Garcia , Graham Sophia , Liu Olivia , Zhu Yajun , Lorenzo Maria , Nicol Steven J.
Published: April 2017

147

Background: Soft-tissue sarcomas (STS), a rare heterogeneous group of cancers originating in the muscle, fat, blood vessels or other fibrous/connective tissues, account for 1% of all cancers diagnosed annually in the US. The National Comprehensive Cancer Center guidelines include a wide range of regimens that lack supporting randomized trial evidence, and there are few treatment pathways to guide treatment decision making. A discrete choice experiment (DCE) was conducted to quantify the relative value of overall survival (OS), progression-free survival (PFS), tumor response rate (RR), risk of hospitalization due to side effects, and convenience of therapy (days per month to administer treatment) among oncologists. Methods: An online DCE survey was administered to oncologists recruited from an online panel, who were licensed to practice in the US at the time of the survey and prescribed chemotherapy to patients with STS. Oncologists were asked to choose between pairs of hypothetical treatments characterized by a common set of attributes: OS (14, 20 or 26 months), PFS (3, 5 or 7 months), RR (12, 18, or 26%), risk of hospitalization due to side effects (12, 30 or 46%), and days/month to administer treatment (1, 2 or 4 days). A hierarchical Bayes model was used to analyze preferences, the relative importance of treatment attributes (from 0-100%), and trade-offs between attributes. Results: 160 eligible oncologists completed the survey: 74% male; 41% private practice; and 64% affiliated with an academic teaching hospital. OS had the highest relative importance (44.6%, standard deviation, SD, 16.0%), followed by the risk of hospitalization (18.4%, SD 8.3%). PFS, RR, and days to administer treatment had lower relative importance (16.5%, 10.6%, and 9.9%, respectively). For a 1-month increase in OS, oncologists were willing to trade off 8.9 percentage points increase in hospitalization risk, a 2.1 month reduction in PFS, 13.1 percentage points decrease in RR, and an additional 4.6 days/month to administer treatment. Conclusions: Oncologists in the US value maximizing the life of patients with STS while avoiding hospitalizations. Patient preference interviews are ongoing with patients with STS, which will be presented at the meeting.
Carcinoid Syndrome Impact Survey: Evaluation of the burden of illness and the gap between patient and oncologist perceptions.
Authors: Goldstein Grace , Evans Kathleen , Shah Arpan , Lapuerta Pablo
Published: April 2017

151

Background: Patients with advanced neuroendocrine tumors (NETs) may develop carcinoid syndrome, a rare condition characterized by debilitating symptoms including diarrhea, flushing and valvular heart damage that can greatly affect patient social and physical functioning. Limited information is available on the physician perceptions of carcinoid syndrome and areas that differ from patients. The Carcinoid Syndrome Impact Survey probed potential gaps in oncologist, patient and caregiver perception and the overall burden of the disease. Methods: The survey designed in collaboration with patient advocacy groups was conducted (June-October 2016) among 538 patients with carcinoid syndrome, 94 caregivers, and 151 oncologists. The online, anonymous survey consisted of demographic and disease-related questions including symptom frequency, and impact to daily living of carcinoid syndrome. Each group of respondents was given mirrored questions whenever possible to allow for comparison across groups. Questions were based primarily on a 4-level Likert scale. Results: Differences in perception of symptom frequency, syndrome severity and impact of carcinoid syndrome on daily living were observed between patients, caregivers, and oncologists. Patients and caregivers were more likely to report symptom frequency as > 21 days a month (39% caregivers vs 38% patients vs 4% oncologists). Most oncologists cited symptom frequency as 1-7 days a month (50% of oncologists). Patients were more likely to report carcinoid syndrome affecting them ‘a great deal’ (62% patients vs 23% oncologists). Caregivers were most likely to report the highest category of severity compared to patients and physicians (39% caregivers vs, 25% patients vs 17% oncologists). Conclusions: Oncologists may not be fully aware of the impact of carcinoid syndrome on patient daily living. Furthermore, caregivers may perceive aspects of disease burden to which patients have habituated and may not report as frequently. Tools to encourage more explicit dialogue between patients with carcinoid syndrome and oncologists are needed to narrow the information gap and subsequently improve treatment outcomes.
The role of annual personal health visits (APHV) on patients' with cancer knowledge and perceptions of the harms of continued smoking.
Authors: Farzanfar Delaram , Lu Lin , Su Jie , Alton Devon , Mohan Rahul , Liu Sophia , Krys Olivia , Yoannidis Tom , Brown M Catherine , Vennettilli Ashlee , Hope Andrew J. , Howell Doris , Jones Jennifer M. , Selby Peter , Xu Wei , Goldstein David Paul , Giuliani Meredith Elana , Liu Geoffrey , Eng Lawson
Published: April 2017

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Background: With improvements in cancer detection and therapies, important secondary prevention measures in survivorship include smoking cessation. Primary care providers have an opportunity to discuss these measures with cancer survivors at APHV. We evaluated whether having a recent APHV is associated with cancer patients’ awareness and perceptions of the harms of continued smoking. Methods: Cancer survivors were surveyed from April 2014 to May 2016 with respect to their smoking history, knowledge and perceptions of the harms of continued smoking along with the date of their most recent APHV (term changed from annual health physical examination in 2013). Multivariable logistic regression analyses assessed the association of having an APHV with knowledge and perceptions of the harms of continued smoking. Results: Of 985 cancer patients, 23% smoked at diagnosis; 34% quit > 1 year prior to diagnosis; 55% had tobacco-related cancers; 77% received curative therapy. From a knowledge viewpoint, over 52% reported being unaware that smoking negatively impacts cancer outcomes; despite this, most perceived smoking to negatively influence quality of life (75%), survival (76%), and fatigue (73%). Within the last year, 48% had an APHV, while 84% had an APHV at any time in the past; 18 (2%) reported not having a family doctor. Patients who had an APHV in the last year were more likely to be aware that continued smoking can increase risk of death (adjusted odds ratio (aOR)=1.49, 95% CI [1.13-1.96], P=0.004), and more likely to perceive smoking to negatively impact quality of life (aOR=1.37 [0.94-1.99], P=0.10), survival (aOR=1.60 [0.95-2.71], P=0.08), and fatigue (aOR=1.63 [1.11-2.39], P=0.01). Those ever having an APHV were more likely aware that smoking can increase risk of death (aOR=1.61 [1.07-2.43], P=0.02) and second primaries (aOR=1.53 [1.02-2.33], P=0.04). Conclusions: Having a recent APHV was associated with improved awareness and perceptions of the harms of continued smoking, but it is unclear whether this is related to provider counseling or a healthy bias effect. APHV may be an appropriate time for primary care providers to treat tobacco addiction in their cancer survivors.
Improving shared decision making in chronic lymphocytic leukemia through multidisciplinary education.
Authors: Williams Courtney , Halilova Karina I. , Borate Uma , Jackson Bradford E. , Van Laar Emily Sherene , Pisu Maria , Butler Thomas Wayne , Davis Randall S. , Mehta Amitkumar N. , Knight Sara J. , Safford Monika M. , Rocque Gabrielle Betty
Published: April 2017

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Background: New treatments for chronic lymphocytic leukemia (CLL) with excellent response rates and varying toxicity profiles have emerged in recent years, creating an opportunity for a patient’s personal preferences to contribute to treatment decisions. Methods: We conducted a prospective, quasi-experimental pre- and post-evaluation of a multi-level educational program and its impact on knowledge of CLL as well as on shared decision-making. We educated patients, patient navigators, and providers (nurses and physicians) using a combination of print, video, in-person lectures, and online case-based education tailored to each learner group. Patients were evaluated for change in patient activation, distress levels, desired role in decision-making, perception of decision-making, satisfaction with oncologist explanation of treatment choice, and knowledge of CLL. Patient navigators and providers were evaluated for change in CLL knowledge and perception of shared decision-making. Results: Forty-one patients and 87 providers participated in the educational program. We observed trends toward improved patient activation with 68% before education vs. 76% after education reporting a high (score of 3 or 4) Patient Activation Measure (PAM) . The percentage of patients desiring and perceiving shared decision-making trended upward from 47% to 67% and 35% to 49%, respectively. There was a trend toward an increase in the percentage of patients understanding that CLL is incurable (80% to 90%) and reporting awareness of signs of progression (64% to 76%). Patients satisfaction with their oncologist’s explanation of therapy increased significantly from 83% to 95% (p = 0.03). Conclusions: This modestly sized project demonstrated trends toward improvements in patient engagement, prognostic awareness, knowledge of signs of progression, and shared decision-making; these promising findings should be tested in larger samples. However, there remains an opportunity for further improvement in shared decision-making.
Patient engagement on claims-registry reports of cost and quality.
Authors: Kreizenbeck Karma L. , Fedorenko Catherine R. , Walker Julia Rose , Greenwood-Hickman Mikael Anne , Panattoni Laura , Barger Sarah , Eaton Keith D. , Freeman-Daily Janet , Mapes Diane , Pate Margaret Leigh , Preusse Courtney J. , Lyman Gary H. , Ramsey Scott David
Published: April 2017

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Background: Moving cancer care towards a value framework requires patients, providers, and payers to weigh cost, quality, and outcomes in decision-making. Many efforts are underway to help providers and payers make value decisions, but little has been developed for patients. Our regional value in cancer care effort used a claims-registry database to develop quality and cost reports aiming to provide actionable data to all stakeholders. Methods: Reports were generated using cancer registry records for Western WA from 2007-2015 linked with claims from two regional commercial insurers. Patients were presented quality reports on regionally prioritized metrics and the 2012 ASCO Choosing Wisely guidelines on breast cancer surveillance and EOL care. Patients also reviewed cost reports for episodes of care (diagnosis, treatment, end-of-life (EOL)) and out-of-pocket (OOP) cost estimates. Feedback stemmed from 1) stakeholder meetings over a 2-year period, 2) working groups of patients, payers and providers, and 3) an annual regional meeting on value in cancer care. Results: In total, 13 patients provided feedback at one or more outreach event. See table. Conclusions: Reports from a claims-registry database may not support the information needs of patients for care decision-making or representing “value”. Patients desired understanding more about patients “like them” for decision-making. [Table: see text]