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Pain

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The Carevive Care Planning System (CPS) was developed to overcome challenges by providing an efficient, clinically integrated solution for both psychosocial and physical symptom distress screening and management through the delivery of personalized and evidence-based care plans at the point of care. The Carevive CPS simultaneously collects and aggregates discrete data for quality reporting and improvement.

The Carevive CPS

The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.

Cancer-related pain is a significant clinical challenge that impacts patient outcomes and remains a significant problem for patients with cancer and their providers. The overall prevalence of cancer pain is high; a recent meta-analysis of 52 studies reported cancer pain prevalence ranging between 52%-77%. Another update reports rates of 39% after curative treatment, 55% during treatment, and 66% in advanced, metastatic or terminal disease. Moderate to severe pain was reported by 38% of all patients. Cancer pain may be cancer related, due to tumor burden causing bone, nerve, and/or organ compression, and/or treatment related, due to procedures, surgery, and side effects of chemotherapy or radiation. The prevalence of pain after breast cancer treatment ranges from 13%-93%; women with metastatic breast cancer often have bone pain from metastases and bisphosphonates. In a nationwide lung cancer study (N = 450), pain was reported by 92% of patients with advanced (stage IIIB/IV) NSCLC. Similar reports indicate pain ranges from 74% to 92%. Uncontrolled pain is the most common chief complaint of unplanned hospitalizations and readmissions. One study reported over half of the chief complaints provided by breast cancer patients with an emergency department (ED) visit were related to poorly controlled pain, respiratory or gastrointestinal symptoms. Finally, there is evidence that high symptom burden and poor management of symptoms and side effects also leads to suboptimal adherence to therapy.

Management of cancer pain requires that the patient be screened for the presence of pain at every clinical contact. A comprehensive assessment should be conducted if the patient is experiencing pain, including specific questions about location, duration, severity, quality, timing, duration, and impact on quality of life. A thorough understanding of pain also considers the temporal characteristics of the pain experience, determining if the pain is intermittent, that is bursts of severe pain without persistent chronic pain, persistent, with moderate to severe pain present throughout the day, and/or breakthrough pain described as the transient exacerbation of pain despite adequately controlled persistent pain. Breakthrough pain is reported to occur daily in 21%-70% of patients.

The prevalence of psychosocial and physical symptom distress in cancer is so compelling that the Commission on Cancer, the Oncology Nursing Society (ONS), American Society of Clinical Oncology (ASCO), and the National Committee for Quality Assurance (NCQA)'s Patient-Centered Oncology Care Standards all require distress screening that includes pain screening and assessment as a quality mandate in their accreditation and quality certification programs. In addition, the Centers for Medicare and Medicaid Services (CMMS)'s Oncology Care Model (OCM) requires a care management plan that includes symptom management. Included as quality measures are NQF384, pain intensity quantified, and NQF 383, plan of care for pain. In addition, value based care payment models seek to decrease emergency department (ED) visits and hospitalization days.

Carevive recently completed a project designed to improve adherence to quality metrics in breast cancer through education plus use of a tablet-based technology to screen for and manage identified distress, pain, and other breast cancer quality indicators available within ASCO's Quality Oncology Practice Initiative (QOPI) program. The Breast National Quality Standards project used QOPI metrics to evaluate outcomes of a CME intervention and use of the Carevive CPS. Preliminary data from this project showed improvement in key areas. Provider adherence to quality metrics was measured in 151 non-metastatic BC patients, 77 of which served as historical controls with no CME/clinical intervention, and 74 received the intervention after their provider participated in certified continuing medical education (CME) activities designed to educate about evidence-based assessment, decision-making, and management strategies for BC patients. Preliminary analysis showed that the intervention improved provider adherence to four pain quality measures: a. pain assessed by second office visit, b) pain intensity quantified by second office visit, c) plan of care documented, and d) pain assessed on either of the two most recent office visits. This project will build on that work to incorporate a comprehensive assessment and a more multi-faceted intervention that engages the care team in a SDM process around cancer pain management.

Along with an imperative to formalize a pain management plan is the rising importance of incorporating shared-decision-making, the cornerstone of patient centered care, into all care decisions. When making treatment decisions, the provider must incorporate current literature, patients' current clinical status, and patient preferences. One challenge with measuring quality through electronic chart abstraction is the difficulty of identifying when patient preference has influenced treatment decisions. Little data currently exist on the level of patient engagement in decision-making for pain management and the perception of patients with MBC, LC, or AC of shared-decision-making in developing a pain management care plan. Dr. Jeannine Brant and colleagues have developed the Pain Care Quality Survey (PainCQ©). The PainCQs are two tools that measure the quality of nursing and interdisciplinary care related to pain management as perceived by hospitalized individuals. These tools will be modified in this project to capture the variable contributions of different members in the care team, including oncology nursing staff.

Strategies to better manage chronic and breakthrough cancer pain are critical. Many cancer centers have incorporated distress screening using either the National Comprehensive Cancer Network (NCCN) Distress Thermometer or the Edmonton Symptom Assessment Scale (ESAS) tools. However, structured processes are typically lacking within the clinical workflow to seamlessly integrate and conduct a more in-depth assessment of those patients who score positively for pain. Processes and technologies that facilitate better integration of pain assessment and pain management care strategies into the oncology team's clinical workflow, while simultaneously integrating algorithms for treatment of pain have the potential to further drive evidence-based care.

Shared Decision Making in Pain Management Planning in Patients With Cancer

Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).

The PainCQ measures the patient's perception of the quality of pain management by the interdisciplinary team and whether the patient felt included in decision making.

Participating OCM practices will complete a single feasibility assessment measuring completeness of each intervention tool

Carevive Systems, Inc.

Neoplasms

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.

Carevive CPS

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.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin 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 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Shared Decision Making in Pain Management Planning in Patients With Cancer	NCT03304145	Cancer	The Carevive CP...	18 Years -	Carevive Systems, Inc.
Understanding Evidence-Based Practice Patterns in Advanced NSCLC	NCT03107156	Non Small Cell ...	Carevive CPS	18 Years -	Carevive Systems, Inc.
Metastatic Breast Cancer Treatment Planning	NCT03127332	Metastatic Brea...	Carevive CPS	18 Years -	Carevive Systems, Inc.

Spots Global Cancer Trial Database for treatment care planning