Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

This intervention will focus on the use of the Carevive CPS at a surgical visit, enabling providers to deliver evidence-based and personalized treatment care plans to their breast cancer patients. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

Carevive CPS

This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning System at the point of care plus provider continuing medical education.

The overarching goals are to improve clinician knowledge about evidence-based practices for neoadjuvant therapy for breast cancer, increase appropriate referrals to medical oncology for consideration of preoperative systemic therapy (as determined by adherence to NCCN pre-operative systemic therapy guidelines), and to improve communication between the multidisciplinary team and patient regarding the appropriateness, selection, and timing of neoadjuvant therapy. Secondary objectives include a) evaluation of the impact of the intervention on actual prescription of neoadjuvant therapy to eligible patients and b) evaluation of the impact of the intervention on surgeons and medical oncologists' knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy. We will also explore the acceptability and utilization of the Carevive care plan during medical oncologists' initial consultations after referral of patients from surgical practices. In this project, 25 newly diagnosed breast cancer patients will be recruited over a 3-6 month period, screened for eligibility for neoadjuvant therapy, and assessed for patient treatment preferences at time of surgical consultation using a novel and commercially available electronic technology, the Carevive Care Planning System (CPS). Patients will receive a care plan that explains neoadjuvant therapy among possible treatment options. In addition, patients will be screened for distress as well as eligibility for genetic counseling (according to NCCN referral criteria) and fertility preservation (according to ASCO guidelines) referrals, and the Carevive care plans provided will also incorporate personalized referrals to these related services where applicable.

Retrospective chart reviews (from both surgical and medical oncology practices participating in this project), complemented by data extracted from the Carevive CPS, will be used to assess changes in rates of referrals to medical oncology for discussion and actual prescriptions of neoadjuvant therapy, as compared to historical data from prior publications documenting low rates of referral to, and receipt of, neoadjuvant therapy. Provider questionnaires exploring knowledge, attitudes, and beliefs about the benefits of neoadjuvant therapy will be completed at baseline and again at follow-up (≤4 weeks following intervention visit of their last patient) and changes will be explored using a pre-/post-test design. Use of a care planning technology to provide tailored education and individualized information may provide an easy, accessible and effective way to improve provider abilities to proactively identify patients eligible for specific therapies, understand patient treatment goals, concerns, drive shared decision making (SDM) and sufficiently collaborate with the multi-disciplinary team to provide optimal care.

Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning

Data collected via chart abstraction and provider surveys will be analyzed.

Data will be collected via chart abstraction

Carevive Systems, Inc.

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

This intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers.

The overarching objective of this study is to evaluate the symptom assessment and management behaviors used by multiple myeloma (MM) providers for alignment with evidence-based practices, and to explore changes in these symptom care behaviors from baseline to following use of the Carevive Care Planning System (CPS). The overarching goal of the larger program of research is to evaluate the impact of the platform on symptom assessment and management strategies with individuals receiving treatment for multiple myeloma. The current study is focused on determining feasibility of research methods and effect size finding so as to gather the requisite data needed to design fully powered hypothesis testing studies.

Treatment of multiple myeloma (MM) is currently undergoing rapid transformation. With so many new agents and regimens to choose from, significant practice gaps have emerged in the treatment and management of newly diagnosed MM patients. Innovative strategies are needed to (1) enhance the personalized treatment of MM and (2) proactively identify, assess, and manage disease- and treatment-related symptoms so that new therapies are optimally translated to practice. This study will explore the symptom assessment and management practices of providers caring for individuals receiving active therapy for multiple myeloma, and will also employ a two-part intervention (with both patients and providers) to evaluate the impact of a novel existing technology, the Carevive Care Planning System (CPS), on supportive care and symptom management for multiple myeloma patients. The primary objective of this study is to evaluate provider adherence to evidence-based practices for symptom assessment and management (i.e., "symptom care behaviors") of physicians and nurses (providers) caring for individuals receiving active treatment for multiple myeloma (MM). Carevive. The Carevive intervention will include personalized supportive care and symptom management plans for patients auto-generated by the Carevive CPS based on each individual's data. The Care plans were created based on nationally recognized National Comprehensive Cancer Network (NCCN) supportive care guidelines and validated by a Multiple Myeloma (MM) nurse and physician experts. Investigators will use a study-specific scorecard of evidence-based symptom assessment and management metrics to evaluate adherence of provider (n=8-20) symptom assessment and management behaviors, measured at the individual patient (n=120) level, to evidence-based practices for symptom care. Changes in adherence to evidence-based practices will be explored using an across subject comparison to retrospective data abstracted from a matched sample of historical controls. Use of a care planning technology to provide tailored education and individualized information may provide an easy, accessible and effective way to improve supportive care and symptom management for individuals receiving active treatment for multiple myeloma.

Multiple myeloma (MM) is a neoplastic plasma-cell disorder characterized by clonal proliferation of malignant plasma cells in the bone marrow microenvironment, monoclonal protein in the blood or urine, and associated organ dysfunction. In 2014, approximately 24,050 new cases of MM will be diagnosed and 11,090 deaths are expected to occur. The treatment of MM is currently undergoing a rapid evolution. The FDA has approved several new agents over the past several years. Dozens of regimens are now available, with best practices and consensus guidelines continually evolving as new data are published. Indeed, major updates to the International Myeloma Working Group (IMWG) and the 2014 National Comprehensive Cancer Network (NCCN) guidelines highlight the recent revolution in MM care.

With so many agents and regimens to choose from, it is more crucial now than ever for providers to understand how to individualize treatment and symptom management based on patient- and disease-related factors. However, significant practice gaps exist among providers treating patients newly diagnosed with MM. Transplant eligibility, cytogenetics, comorbidities, renal function, and other factors are often not adequately considered when designing personalized induction, consolidation, and maintenance treatment plans. In addition, institutional MM pathways often do not include symptom management. Adverse events are common in patients with MM, and can be dose limiting, forcing patients to change therapies and jeopardize treatment outcomes.

A between subject design using matched historical controls from each institution will be used to evaluate adherence of provider (n=8-20) symptom assessment and management behaviors, measured at the individual multiple myeloma (MM) patient (n=120) level, to evidence-based practices for symptom care, and to explore correlates of adherence to these evidence-based symptom care behaviors. Retrospective reviews of enrolled patient participant charts will be conducted to evaluate achievement of adherence to evidence-based practices at the individual patient level, following engagement with the two part study intervention, plus a novel individualized care planning technology (Carevive CPS). Retrospective chart reviews will be completed on de-identified, matched historical controls (matching on demographics, diagnosis and treatment variables) at each institution (e.g Cleveland Clinic) to assess the impact of the project intervention on the outcome metrics. Data will be entered into the score card appendix B. The use of matched historical controls for comparative analyses addresses the threat of diffusion of intervention; i.e., that participation in this project will have an impact on provider's clinical behaviors in caring for all patients and thus would potentially effect baseline data collection on patients enrolled later on in the study. Providers will be caring for individuals receiving active treatment for multiple myeloma (MM).

The Carevive CPS intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers. Changes in symptom assessment and management behaviors will be assessed by matching against a scorecard of evidence-based symptom assessment and management metrics. A scorecard metric is being developed by an interdisciplinary team and will be informed by similar approaches used within the Oncology Nursing Society's (ONS) Quality Initiative. Recommendations for symptom assessment and management as well as other evidence based recommendations will be operationalized as metrics.

The intervention is centered on use of the Carevive CPS at the point of care, in conjunction with two consecutive clinical visits, baseline and the second, similar questionnaire will be completed at a clinic visit that occurs at least 4 weeks later. Eligible patients and potentially eligible visits will be identified via weekly chart review of upcoming clinic schedules and of corresponding individual patient medical records. In the exam room, prior to their potential baseline study visit, the patient will be approached and informed of the study (for follow-up visits, patients will be approached and reminded of the study). Once a patient has consented, research staff will open the electronic questionnaire via the Carevive CPS application on one of the study designated tablet computers or secure Cleveland Clinic desktop device according to patient preference . Research staff will then either a) register the patient using their year of birth and a unique Study ID numbers assigned by the Cleveland Clinic or b) open the patients' already existing file (follow-up). The research staff will then select and open the appropriate questionnaire (baseline or interim) and allow the patient to complete. The patient will report their symptoms, history, and current concerns. Once the patient has completed the questionnaire, the survey window will automatically close. Data will be stored centrally and managed by a third party (PRS) in a HIPAA compliant manner. The study research coordinator will then enter limited clinical data into the Diagnosis and Treatment Summary section of the Carevive CPS and click submit. Once submitted, the total composite of ePRO and research staff entered data will run through the guideline-driven and proprietary Carevive CPS algorithms to auto-generate a draft supportive care plan. The draft care plan contains, based on individual patient data, personalized supportive care and symptom management data to be reviewed by the provider during visit. The patient will proceed to the intervention visit where the provider will review, edit if needed, finalize and deliver the electronic care plan (and/or a print copy) to each patient. The patient will also be provided with his or her own copy of the care plan (electronically via email, thumb drive and/or paper) to take home.

Research staff will track patient enrollment and monitor return visits for all participants that fall within the follow-up visit window which begins at least 4 weeks later (+/- 1 week) and continues until the second survey is completed. At this follow up visit, the study patients will take their second electronic survey in the Carevive CPS, and receive their second provider-approved care plan. Patients will also be offered the opportunity to complete a brief questionnaire on their satisfaction with, and utilization of, the care plan since their first intervention visit. The questionnaire will ask about specific recommendations made within the care plan and if the patient recalls receiving it and what action, if any, they have taken. Patients will be offered the opportunity to complete this survey on the study provided tablet or secure Cleveland Clinic desktop device at the time of their second visit or to have a link to the survey emailed to them to be completed at their leisure. This survey will be completed independently of the Carevive CPS through the on-line survey hosting site Surveymonkey.com and will be optional for patients.

Study-specific data collection will occur at multiple time points. Chart reviews of enrolled patient participants will the period of time from baseline intervention (baseline visit) to 12-weeks post the second intervention (encompassing the follow-up visit). Retrospective chart abstractions for the matched controls examine a 12-week time period matched as close as possible to the intervention time period of their respective enrolled patients. Retrospective chart reviews can occur at any time. Chart reviews must reflect the time period of enrolled patients. Patient satisfaction and utilization questionnaire will be completed at or following the follow-up visits. Data sources include the patient questionnaire, previously collected data collected as part of the study intervention and stored within the Carevive CPS platform database (for enrolled patients) limited diagnosis and treatment data on controls (for matching purposes), as well as chart review score card data. A brief worksheet collecting care plan delivery variables (e.g., who delivered the care plan to the patient, how much time was spent reviewing the care plan, etc.) will also be completed by the research staff following each clinic visit at which a care plan is delivered.

Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans

Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans: Pilot Testing the Impact of Continuing Education and Care Planning on Symptom Management

Charts will be abstracted and data will be entered into scorecards to determine whether participating providers adhered to evidence-based practices for symptom assessment and management for study participants.

Charts will be abstracted and data will be entered into scorecards to explore changes in symptom care behaviors following engagement with a supportive care intervention (the Carevive CPS), and compare to adherence rates for historical controls from the pre-intervention period.

Clinicians will complete a qualitative survey at the end of the study to report the amount of time they spent reviewing and delivering care plans with study participants.

The study will explore patient satisfaction and utilization of care plans by asking patients a series of qualitative questions.

Symptoms and General Pathology

Behaviors and Mental Disorders

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Quality of Life

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

This intervention will focus on the use of the Carevive CPS, enabling providers to deliver evidence-based and personalized treatment care plans to their CLL patients on/starting treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

This multi-site study will enroll approximately 100 CLL patients across 5 cancer institutions. The aim of the project is to ensure hematology care teams that are participating in new value-based reimbursement models have an accurate understanding of the evidence and roles of new therapies for CLL and best practice supportive care protocols to proactively assess, monitor, and manage symptoms to promote successful clinical outcomes. Hematology teams at seven health systems across the U.S. will be given online clinical training on the latest evidence for treatment planning in CLL along with best supportive care practices for patients on novel CLL treatments, prior to using Carevive's patient engagement software. Once training is complete, the Carevive software will be employed in the clinic whereby CLL patients will use the Carevive patient portal to report any symptoms at and in between clinic visits. Patients will be given a user name and password to a web-based portal for 24/7 reporting of symptoms experienced. Patient-reported and clinical data will be processed by the Carevive rules engine technology to generate evidence-based supportive care plans providing patients with direction regarding self-management strategies, care coordination for relevant cancer center services, and direction on when to go to the emergency department (ED) or call their hematologist based on their institution's protocol. For patients who require ongoing and routine monitoring, such supportive care recommendations will be included in supportive care plans generated at the clinic visit. On the visits subsequent to the delivery of the care plan, patients will report on the perceived effectiveness of the intervention (or barriers to non-adherence to the intervention). Patients and clinicians will assess symptom severity at each visit for a 16-week period and both data sets will be stored and analyzed for research purposes.

Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia in Western countries with 18,960 new cases and 4660 deaths expected in 2016. Rapid therapeutic advances in the past five years have changed the landscape of CLL treatment giving patients many more treatment options. Fit patients with favorable disease features such as mutated immunoglobulin heavy chain variable region (IgHV genes) have long term benefit from chemoimmunotherapy and new oral agents such as ibrutinib and idelalisib and the BCL-2 inhibitor, venetoclax, provide effective options for relapsed patients.

With recent FDA approvals, the treatment armamentarium for relapsed/refractory CLL has been transformed in the past several years. Clinicians are faced with a plethora of new treatment options and associated guideline updates, making clinical decision-making much more complex. It is challenging for the modern-day hematologist to stay current on the comparative evidence of the risks/benefits of various treatment options with so many choices. Such novel regimens are changing the survival outcomes and offering new opportunities for the long-term management of CLL. While risk-benefit profiles are favorable, diligent supportive care practices are required to promote patient engagement and successful clinical outcomes as such agents are powerful, leading to potential toxicities that must be diligently monitored.

Since new agents have had limited use in the clinic, real-world evidence on patient symptom experience is not available to guide practice and there is limited data on the effectiveness of evidence-based supportive care recommendations. This is a challenge for hematology teams, particularly because CLL patients are amongst the highest rates of emergency department (ED) visits and hospitalizations (along with lung and colon cancers). Retrospective data demonstrated that patient demographic and clinical characteristics, as well as chemotherapy choice, were associated with ER visits and hospitalizations in patients with CLL. Specifically, significant increases in ER visits and hospitalizations were associated with age, comorbidities, use of supportive care, number of CLL-related adverse events, chemotherapy duration, use of certain therapies, living in the Northeast region of the United States, and treatment following relapse.

The outcomes of CLL treatment have been found to vary with age, with poorer outcomes in older patients. However, the elderly population is highly heterogeneous - ranging from "fit" to "frail". A number of recent studies conclude that while chronological age is an important consideration when making treatment decisions for hematologic malignancies, functional status is more predictive of treatment outcomes. A review of 83 CLL treatment articles published from 1949 to 2011 reported fit patients had more treatment options than the frail elderly and most studies included patients younger than 65 years. It has been noted by a number of researchers that elderly and frail patients with LGL are under-represented in clinical trials and there is need for data to support a tailored treatment plan.

This study will explore the symptom assessment and management practices of providers caring for individuals receiving new and active therapy for CLL, and will also employ a two-part intervention (with both patients and providers) to evaluate the impact of a novel existing technology, the Carevive Care Planning System (CPS), on supportive care and symptom management. The primary objective of this study is to evaluate adherence to evidence-based practices for symptom assessment and management (i.e., "symptom care behaviors") of physicians and nurses (providers) caring for individuals receiving active treatment for CLL. The intervention will include personalized supportive care and symptom management plans for patients auto-generated by the Carevive CPS based on each individual's data. The care plans were created based on nationally recognized National Comprehensive Cancer Network (NCCN) supportive care guidelines and validated by CLL nurse and physician experts.

Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study

The Roles of Education and Patient Engagement to Improve Symptom Management and the Quality of Life for Patients With Chronic Lymphocytic Leukemia

Patients will be asked to rate how acceptable, effective, and usable the web-based technology was using a 5-item system usability measure. The data will then be analyzed in order to describe the patient perceptions of the intervention

Data collected on the Carevive CPS using the PRO-CTCAE and ESASr tools will be analyzed in order to describe the longitudinal symptom experience

To explore how frequently older adults with CLL are hospitalized or visit the ER as a result of the CLL diagnosis

To describe how provider decision making patterns change over time for providers who are treating the CLL patients in the study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their NSCLC patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

The overarching objective of this study is to close clinical knowledge and performance gaps by providing oncology clinicians with the latest advances and emerging research in the evidence-base and personalized treatment of advanced NSCLC patients. In addition, the research team seeks to meet quality measures relevant to value-based care delivery through IT infrastructure and clinical workflow processes. The research team also hopes to gain insights on clinician practice patterns related to advanced NSCLC, and the correlation between advanced NSCLC patients reported goals of care and advanced NSCLC patients' fit/frailty status and treatment decisions.

Non-small cell lung cancer (NSCLC) accounts for about 25% of all cancer deaths and is by far the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. NSCLC mainly occurs in older adults. About two out of three people diagnosed with lung cancer are 65 or older; the average age at the time of diagnosis is 70 years. Despite the many advances over the past few decades related to surgery, radiation therapy and chemotherapy, death rates attributable to lung cancer have remained relatively unchanged. Most patients are diagnosed with distant disease and have a 5 -year survival of only 4%. Today, however, there is renewed optimism that these trends have started to change as recent research advances have led to an explosion in lung cancer genetic and biologic knowledge among NSCLC scientists and expert clinicians. A major focus of recent lung cancer research has been the development and subsequent approval of several immunotherapy and molecular-targeted agents and the identification of related biomarkers to help guide treatment selection for those individuals who harbor specific oncogenic alterations.

Improvements in advanced NSCLC outcomes have been achieved by the discovery of predictive molecular markers that identify subgroups of patients that may derive benefit from targeted treatment. Multiple molecular markers have been found to have clinical value in advanced NSCLC: EGFR mutations, ALK rearrangements, as well as HER2, MET, B-RAF, RET, and ROS1. In addition, the classification for lung adenocarcinoma was recently revised and now requires morphology, immunohistochemical, and molecular studies, including EGFR and ALK status, as well as ROS1, BRAF, HER2, MET, RET. It is thus important that proper biopsy technique accommodate these crucial tests, that the correct tests are ordered for specific patient populations, and that the results of testing are accurately interpreted to individualize care for patients with targeted agents such as erlotinib, afatinib, crizotinib, and osimertinib. Molecular testing for NSCLC is not ordered routinely due to insufficient knowledge by the multidisciplinary team (medical, surgical, and radiation oncologists) or lack of reimbursement. Several studies have quantified this failure: De Souza et al (2012) showed that no testing for EGFR mutations was observed in 23.5% of patients administered erlotinib, and Pan et al (2013) demonstrated that EGFR testing rates were only 2.3% before 2010, 15.2% in 2010, and still only 32.0% in 2011. Similarly, Spicer et al (2015) demonstrated that 23% of oncologists do not consider EGFR mutation subtypes in making treatment decisions and EGFR mutation testing is not performed in up to 25% of patients. A survey of 133 US medical oncologists found that most (74%) are not very familiar with using biomarkers to tailor therapy. In addition, lung cancer test panels often do not include next generation sequencing, which can greatly streamline the process. Biopsies are often too small or too low quality for adequate testing, necessitating rebiopsy. For example, Ost et al (2013) found that only 21% of patients had a diagnostic evaluation consistent with guidelines.

National guidelines on molecular testing in NSCLC are available from the NCCN, ASCO, College of American Pathologists, International Association for the Study of Lung Cancer, Association for Molecular Pathology, and others. These guidelines make evidence-based recommendations to better align the latest clinical research with patient care in practice. For example, the NCCN notes that there is a significant association between EGFR mutations-especially exon 19 deletion and exon 21 (L858R, L861) and exon 18 (G719X, G719) mutations-and sensitivity to TKIs, and that the exon 20 insertion mutation may predict resistance to clinically achievable levels of TKIs. The prevalence of EGFR mutations in adenocarcinomas is 10% of Western and up to 50% of Asian patients, with higher EGFR mutation frequency in non-smokers, women, and non-mucinous cancers. KRAS mutations are most common in non-Asians, smokers, and in mucinous adenocarcinoma. In addition, primary resistance to TKI therapy may be associated with KRAS mutation, so KRAS gene sequencing could be useful for the selection of patients as candidates for TKI therapy. ALK fusions have been identified in a subset of patients with NSCLC and represent a unique subset of NSCLC patients for whom ALK inhibitors may represent a very effective therapeutic strategy.

The current treatment of advanced NSCLC is based on the evaluation of genetic mutations that can guide the personalization of treatment with molecularly targeted agents. The most common genetic variant is the gene that encodes the epidermal growth factor receptor (EGFR) and is found in approximately 15% of Caucasian and more than 50% of Asian patients. Patients harboring EGFR mutations are usually treated with tyrosine kinase inhibitors (TKI), such as gefitinib, erlotinib or afatinib. Similarly, a gain of function of anaplastic lymphoma kinase (ALK) due to a rearrangement with the echinoderm microtubule-associated protein-like 4 (EML4) represents a predictive biomarker of the efficacy of ALK-TKI inhibitors such as crizotinib. However, clinicians may not be adequately informed about newly approved and emerging TKIs.

It is nearly impossible for the modern-day oncologist to remain current regarding the clinical tsunami of research to personalize NSCLC treatment. This is evidenced by the fact that only 55% -75% of NSCLC patients within the United States are receiving evidence-based care. The tremendous pressures cancer centers and their oncology providers face in quantifiably demonstrating value in the care delivered compounds this problem. Almost instantly, government and commercial payers are demanding a change from pay for quantity to pay for value. In April 2016, CMMI implemented the Oncology Care Model (OCM). The new OCM program is complementary to other value-based payment initiatives in which oncologists may participate, including the Bundled Payment for Care Initiative, Chronic Care Management Program, Transforming Clinical Practices Initiative, Transitional Care Management Program, ACO/Medicare Shared Savings Program, and Medicare Care Choice Model, and others rapidly being introduced by commercial payers. These payment programs are transforming oncology care so that it is more pro-active, coordinated, vigilant and patient focused. At the center of this payment reform is the patient, as the ultimate consumer of health care services. Until recently, patients have been relatively blind to the actual cost and quality of the care they receive. Now, out-of-pocket costs are rising steeply and patients have instant access to a trove of health information as they are forced to become better-educated consumers regarding the costs and likely outcomes of their treatment. A recent JAMA Op-Ed piece receiving significant attention highlights that delivering value-based care requires an understanding of what the patient values. To that end, all the current cancer valued-based models require that oncology providers document their patient's goals of care and that the treatment course is evidence-based and commensurate with patient goals.

Another significant component of value is ensuring that a patient is "fit" enough for the treatment selected. The priorities of frail patients, whose care is the costliest, are often not noticed nor met. The issue of fit/frailty status in NSCLC is highly relevant, given that the average age of diagnosis is 70. When older adults are ill, they are more prone to hospitalization; higher health care utilization due to cancer toxicities drive up the cost of health care. Older adults have an 11-fold increased incidence of cancer and a 16-fold increased incidence in cancer mortality compared to younger patients. Only 25% of patients over 65 received chemotherapy, posited to be the standard of care. And those who do receive chemotherapy are underrepresented in clinical trials. Comprehensive geriatric assessment (CGA) is recommended to stratify elderly patients with advanced NSCLC to ensure treatment dosing that balances efficacy and toxicity.

Historically GAs are not routinely performed because they are complex and time-consuming, the optimal tools for administering the GA accurately and efficiently have not been established, many clinicians lack knowledge about how to incorporate GA into decision-making and care of older adults, and integration of a GA into a Health Information System platform has not been adequately studied for feasibility and usage. Hurria and colleagues developed the Cancer Specific Geriatric Assessment (CSGA), a shorter assessment that specifically captures data from seven domains (functional status, comorbid medical conditions, psychological state, cognition, nutritional status, social support, and medications). The CSGA requires nearly 30 minutes to complete which lessens its usefulness in a busy clinic.

A modified Geriatric Assessment (mGA) tool that utilizes age, functional status as determined by assessment of activities of daily living (ADLs) and instrumental activities of daily living (IADLs), plus comorbidity status was used to develop the Palumbo Frailty Index (FI). The FI categorizes patients into groups of fit, intermediate fit, and frail. In a retrospective analysis of data in 867 older adults with MM, toxicity, treatment discontinuation, and survival rates were correlated with the FI. As a result of this retrospective validation work, fit/frailty status is now being evaluated in the clinical setting by gathering information from a mGA and providing the data to the care provider to guide treatment decisions. Predictors of toxicity in elderly patients include age, tumor/treatment variables, labs, and geriatric assessment variables. The mCGA used in this study includes assessment of activities of daily living (ADLs), instrumental ADLS (IADLs), risk for toxicity using the Cancer and Aging Research Group's (CARG) "Chemotherapy Toxicity Calculator" and additional variables such as age, falls in the past six months, hearing, peripheral neuropathy, creatinine clearance, stage and date of diagnosis.

The science of value-based cancer care is in its infancy. The association of quality and patient outcomes are still largely a thing of the future-to be informed by longitudinal studies to come that will involve a new generation of better-structured big data. Thus, aligning evidence-based treatment decisions with patient goals and patient's performance/fit status is an imperfect science. There is no better case of such a conundrum than with the advanced NSCLC patient population, where disease is often aggressive, treatment choices are numerous and complicated, patients often have high disease and treatment-related symptom burden, and the overall survival trajectory is sadly among the shortest of all cancer diagnoses.

Understanding Evidence-Based Practice Patterns in Advanced NSCLC

Understanding Evidence-Based Practice Patterns in Advanced NSCLC: An Educational/Research Initiative in Mid-Atlantic States

To explore how frequently older adults with lung cancer are hospitalized or visit the ER as a result of their lung cancer.

Data collected on the Carevive CPS will be analyzed in order to correlate the patient biomarker testing results with treatment selections.

An in-person workshop will be held at which clinicians treating patients with NSCLC will gather in discussion regarding what value-based care is and how it affects their patients.

Clinician practice patterns of medical oncologists managing older patients with advanced NSCLC, including sub-analyses of practice patterns for those who are considered "fit", "intermediate fit", and "frail," will occur.

This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their metastatic breast cancer patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

The overarching objective of this study is to close clinical knowledge and performance gaps by providing oncology clinicians with the latest advances and emerging research in the evidence-based and personalized treatment of metastatic breast cancer patients. In addition, the research team seeks to meet quality measures relevant to value-based care delivery through IT infrastructure and clinical workflow processes. The research team also hopes to gain insights into clinician practice patterns related to metastatic breast cancer, and the correlation between the reported goals of care for patients with metastatic breast cancer, and the patients' fit/frailty status and treatment decisions.

Breast cancer is one of the most commonly diagnosed cancers for women in the United States, with an estimated 246,660 cases of invasive breast cancer and 61,000 cases of in situ breast cancer to be diagnosed in 2016. It is also the second leading cause of cancer death for women, with an estimated 40,450 deaths to occur this year. The therapeutic environment for the treatment of MBC is evolving rapidly. Clinicians are challenged with understanding new molecular targets, and identifying ongoing clinical trial opportunities for this patient population. Healthcare providers are required to be aware of the mechanisms of action, safety, and efficacy of promising novel agents and regimens on the horizon for the treatment of advanced breast cancer. Furthermore, central to individualizing therapy is an assessment of patients' goals of treatment prior to developing a plan of care.

It is nearly impossible for the modern-day oncologist to remain current regarding the clinical tsunami of research to personalize MBC treatment. The tremendous pressures cancer centers and their oncology providers face in quantifiably demonstrating value in the care delivered compounds this problem. Almost instantly, government and commercial payers are demanding a change from pay for quantity to pay for value. In April 2016, CMMI implemented the Oncology Care Model (OCM). The new OCM program is complementary to other value-based payment initiatives in which oncologists may participate, including the Bundled Payment for Care Initiative, Chronic Care Management Program, Transforming Clinical Practices Initiative, Transitional Care Management Program, ACO/Medicare Shared Savings Program, and Medicare Care Choice Model, and others rapidly being introduced by commercial payers. These payment programs are transforming oncology care so that it is more pro-active, coordinated, vigilant and patient focused. At the center of this payment reform is the patient, as the ultimate consumer of health care services. Until recently, patients have been relatively blind to the actual cost and quality of the care they receive. Now, out-of-pocket costs are rising steeply and patients have instant access to a trove of health information as they are forced to become better-educated consumers regarding the costs and likely outcomes of their treatment. A recent JAMA Op-Ed piece receiving significant attention highlights that delivering value-based care requires an understanding of what the patient values. To that end, all the current cancer valued-based models require that oncology providers document their patient's goals of care and that the treatment course is evidence-based and commensurate with patient goals.

Another significant component of value is ensuring that a patient is "fit" enough for the treatment selected. The priorities of frail patients, whose care is the costliest, are often not noticed nor met. The issue of fit/frailty status in breast cancer is highly relevant, given that the median age at diagnosis is 62 with 57% cases of invasive breast cancer in females being diagnosed at age 60 or older. When older adults are ill, they are more prone to hospitalization; higher health care utilization due to cancer toxicities drives up the cost of health care. Older adults have an 11-fold increased incidence of cancer and a 16-fold increased incidence in cancer mortality compared to younger patients. Comprehensive geriatric assessment (CGA) is recommended to stratify elderly patients with advanced breast cancer to ensure treatment dosing that balances efficacy and toxicity.

Historically GAs are not routinely performed because they are complex and time-consuming, the optimal tools for administering the GA accurately and efficiently have not been established, many clinicians lack knowledge about how to incorporate GA into decision-making and care of older adults, and integration of a GA into a Health Information System platform has not been adequately studied for feasibility and usage. Hurria and colleagues developed the Cancer Specific Geriatric Assessment (CSGA), a shorter assessment that specifically captures data from seven domains (functional status, comorbid medical conditions, psychological state, cognition, nutritional status, social support, and medications). The CSGA requires nearly 30 minutes to complete which lessens its usefulness in a busy clinic.

A modified Geriatric Assessment (mGA) tool that utilizes age, functional status as determined by assessment of activities of daily living (ADLs) and instrumental activities of daily living (IADLs), plus comorbidity status was used to develop the Palumbo Frailty Index (FI). The FI categorizes patients into groups of fit, intermediate fit, and frail. In a retrospective analysis of data in 867 older adults with MM, toxicity, treatment discontinuation, and survival rates were correlated with the FI. As a result of this retrospective validation work, fit/frailty status is now being evaluated in the clinical setting by gathering information from a mGA and providing the data to the care provider to guide treatment decisions. Predictors of toxicity in elderly patients include age, tumor/treatment variables, labs, and geriatric assessment variables. The mCGA used in this study includes assessment of activities of daily living (ADLs), instrumental ADLS (IADLs), risk for toxicity using the Cancer and Aging Research Group's (CARG) "Chemotherapy Toxicity Calculator" and additional variables such as age, falls in the past six months, hearing, peripheral neuropathy, , stage and date of diagnosis.

The science of value-based cancer care is in its infancy. The association of quality and patient outcomes are still largely a thing of the future-to be informed by longitudinal studies to come that will involve a new generation of better-structured big data. Thus, aligning evidence-based treatment decisions with patient goals and patient's performance/fit status is an imperfect science.

No, gender identity is not based on self-representation.

Metastatic Breast Cancer Treatment Planning

Impact of Electronic Treatment Plans on Shared Decision Making for Metastatic Breast Cancer: An Educational/Research Initiative

Data collected on the Carevive CPS will be analyzed in order to correlate evidence-based guidelines to individual practice patterns

Clinician practice patterns of medical oncologists managing older patients with metastatic breast cancer, including sub-analyses of practice patterns for those who are considered "fit," "intermediate fit," or "frail" will occur

To explore how frequently older adults with metastatic breast cancer are hospitalized or visit the ER as a result of their breast cancer

Spots Global Cancer Trial Database for carevive cps

Every month we try and update this database with for carevive cps cancer trials from around the world to help patients and their families find trials that might be right for them.
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Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning	NCT03161600	Breast Cancer	Carevive CPS	18 Years -	Carevive Systems, Inc.
Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans	NCT03046329	Multiple Myelom...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Improving the Quality of Multiple Myeloma Treatment With Patient Care Plans	NCT03046329	Multiple Myelom...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study	NCT03231579	CLL	Carevive CPS	18 Years -	Carevive Systems, Inc.
Understanding Evidence-Based Practice Patterns in Advanced NSCLC	NCT03107156	Non Small Cell ...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study	NCT03231579	CLL	Carevive CPS	18 Years -	Carevive Systems, Inc.
Metastatic Breast Cancer Treatment Planning	NCT03127332	Metastatic Brea...	Carevive CPS	18 Years -	Carevive Systems, Inc.