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This study builds on analyses performed as part of an original comprehensive National Cancer Institute Community Cancer Centers Program evaluation and examines improvements in quality of care. The following research questions are addressed: (a) have improvements in concordance rates with the five quality of care measures been sustained since 2010 and (b) how does the change in concordance for minority/underserved patients compare to the change for nonminority/nonunderserved patients through 2013?, Background. The National Cancer Institute Community Cancer Centers Program (NCCCP) pilot was designed to improve quality of cancer care and reduce disparities at community hospitals. The NCCCP's primary intervention was the implementation of the Commission on Cancer Rapid Quality Reporting System (RQRS). The RQRS is a hospital‐based data collection and evaluation system allowing near real‐time assessment of selected breast and colon cancer quality of care measures. Building on previous NCCCP analyses, this study examined whether improvements in quality cancer care within NCCCP hospitals early in the program were sustained and whether improvements were notable for minority or underserved populations. Methods. We compared changes in concordance with three breast and two colon cancer quality measures approved by the National Quality Forum for patients diagnosed at NCCCP hospitals from 2006 to 2007 (pre‐RQRS), 2008 to 2010 (early‐RQRS), and 2011 to 2013 (later‐RQRS). Data were obtained from NCCCP sites participating in the Commission on Cancer Rapid Quality Reporting System. Logistic regression analyses were performed to identify predictors of concordance with breast and colon cancer quality measures. Results. The sample included 13,893 breast and 5,546 colon cancer patients. After RQRS initiation, all five quality measures improved significantly and improvements were sustained through 2013. Quality of care measures showed sustained improvements for both breast and colon cancer patients and for vulnerable patient subgroups including black, uninsured, and Medicaid‐covered patients. Conclusions. Quality improvements in NCCCP hospitals were sustained throughout the duration of the program, both overall and among minority and underserved patients. Because many individuals receive cancer treatment at community hospitals, facilitating high‐quality care in these environments must be a priority. Implications for Practice. Quality improvement programs often improve practice, but the methods are not maintained over time. The implementation of a real‐time quality reporting system and a network focused on improving quality of care sustained quality improvement at select community cancer centers. The NCCCP pilot increased numbers of patients receiving guideline‐concordant care for breast and colon cancer in community settings, and initial improvements noted in earlier years of RQRS were sustained into later years, both overall and among minority and underserved patients. National initiatives that improve care for diverse patient groups are important for reducing and eliminating barriers to care.

PURPOSE Pain, fatigue, and distress are common among patients with cancer but are often underassessed and undertreated. We examine the prevalence of pain, fatigue, and emotional distress among patients with cancer, as well as patient perceptions of the symptom care they received. PATIENTS AND METHODS Seventeen Commission on Cancer–accredited cancer centers across the United States sampled patients with local/regional breast (82%) or colon (18%) cancer. We received 2,487 completed surveys (61% response rate). RESULTS Of patients, 76%, 78%, and 59% reported talking to a clinician about pain, fatigue, and distress, respectively, and 70%, 61%, and 54% reported receiving advice. Sixty-one percent of patients experienced pain, 74% fatigue, and 46% distress. Among those patients experiencing each symptom, 58% reported getting the help they wanted for pain, 40% for fatigue, and 45% for distress. Multilevel logistic regression models revealed that patients experiencing symptoms were significantly more likely to have talked about and received advice on coping with these symptoms. In addition, patients who were receiving or recently completed curative treatment reported more symptoms and better symptom care than did those who were further in time from curative treatment. CONCLUSION In our sample, 30% to 50% of patients with cancer in community cancer centers did not report discussing, getting advice, or receiving desired help for pain, fatigue, or emotional distress. This finding suggests that there is room for improvement in the management of these three common cancer-related symptoms. Higher proportions of talk and advice among those experiencing symptoms imply that many discussions may be patient initiated. Lower rates of talk and advice among those who are further in time from treatment suggest the need for more assessment among longer-term survivors, many of whom continue to experience these symptoms. These findings seem to be especially important given the high prevalence of these symptoms in our sample.

Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

Understanding how health care system structures, processes, and available resources facilitate and/or hinder the delivery of quality cancer care is imperative, especially given the rapidly changing health care landscape. The emerging field of cancer care delivery research (CCDR) focuses on how organizational structures and processes, care delivery models, financing and reimbursement, health technologies, and health care provider and patient knowledge, attitudes, and behaviors influence cancer care quality, cost, and access and ultimately the health outcomes and well-being of patients and survivors. In this article, we describe attributes of CCDR, present examples of studies that illustrate those attributes, and discuss the potential impact of CCDR in addressing disparities in care. We conclude by emphasizing the need for collaborative research that links academic and community-based settings and serves simultaneously to accelerate the translation of CCDR results into practice. The National Cancer Institute recently launched its Community Oncology Research Program, which includes a focus on this area of research.

Background We sought to determine if patient characteristics, including race/ethnicity, were associated with patient-reported care coordination for colorectal cancer (CRC) patients treated in the Veterans Affairs (VA) healthcare system, with the goal of better understanding potential goals of quality improvement efforts aimed at improving coordination.

© 2014 American Cancer Society. BACKGROUND: Research on health-related quality of life (HRQOL) among older adult cancer survivors is mostly confined to breast cancer, prostate cancer, colorectal cancer, and lung cancer, which account for 63% of all prevalent cancers. Much less is known about HRQOL in the context of less common cancer sites. METHODS: HRQOL was examined with the 36-Item Short Form Health Survey, version 1, and the Veterans RAND 12-Item Health Survey in patients with selected cancers (kidney cancer, bladder cancer, pancreatic cancer, upper gastrointestinal cancer, cancer of the oral cavity and pharynx, uterine cancer, cervical cancer, thyroid cancer, melanoma, chronic leukemia, non-Hodgkin lymphoma, and multiple myeloma) and in individuals without cancer on the basis of data linked from the Surveillance, Epidemiology, and End Results cancer registry system and the Medicare Health Outcomes Survey. Scale scores, Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, and a utility metric (Short Form 6D/Veterans RAND 6D), adjusted for sociodemographic characteristics and other chronic conditions, were calculated. A 3-point difference in the scale scores and a 2-point difference in the PCS and MCS scores were considered to be minimally important differences. RESULTS: Data from 16,095 cancer survivors and 1,224,549 individuals without a history of cancer were included. The results indicated noteworthy deficits in physical health status. Mental health was comparable, although scores for the Role-Emotional and Social Functioning scales were worse for patients with most types of cancer versus those without cancer. Survivors of multiple myeloma and pancreatic malignancies reported the lowest scores, with their PCS/MCS scores less than those of individuals without cancer by 3 or more points. CONCLUSIONS: HRQOL surveillance efforts revealed poor health outcomes among many older adults and specifically among survivors of multiple myeloma and pancreatic cancer.

Health care in the United States is notoriously expensive while often failing to deliver the care recommended in published guidelines. There is, therefore, a need to consider our approach to health-care delivery. Cancer care is a good example for consideration because it spans the continuum of health-care issues from primary prevention through long-term survival and end-of-life care. In this monograph, we emphasize that health-care delivery occurs in a multilevel system that includes organizations, teams, and individuals. To achieve health-care delivery consistent with the Institute of Medicine's six quality aims (safety, effectiveness, timeliness, efficiency, patient-centeredness, and equity), we must influence multiple levels of that multilevel system. The notion that multiple levels of contextual influence affect behaviors through interdependent interactions is a well-established ecological view. This view has been used to analyze health-care delivery and health disparities. However, experience considering multilevel interventions in health care is much less robust. This monograph includes 13 chapters relevant to expanding the foundation of research for multilevel interventions in health-care delivery. Subjects include clinical cases of multilevel thinking in health-care delivery, the state of knowledge regarding multilevel interventions, study design and measurement considerations, methods for combining interventions, time as a consideration in the evaluation of effects, measurement of effects, simulations, application of multilevel thinking to health-care systems and disparities, and implementation of the Affordable Care Act of 2010. Our goal is to outline an agenda to proceed with multilevel intervention research, not because it guarantees improvement in our current approach to health care, but because ignoring the complexity of the multilevel environment in which care occurs has not achieved the desired improvements in care quality outlined by the Institute of Medicine at the turn of the millennium.

Patient outcomes are a primary measure by which we assess healthcare delivery quality. Those outcomes are influenced by numerous other factors in the multilevel context of care described in this monograph (1). Factors include policies that enable or impede health-care access, social support from friends and family, processes of health-care teams, organizational procedures in settings where care is delivered, and the environmental context where these behaviors occur. A few years ago, an internal team of researchers at the National Cancer Institute (NCI) within the Division of Cancer Control and Population Sciences recognized the importance of studying the context in which health care is received to intervene on multiple levels of influence. However, the science of multilevel interventions was in an early stage of development. Thus, the NCI researchers (henceforth “the NCI planning team”) reached out to the extramural community to identify expertise that would help advance this science. The collaborations led to a set of draft articles presented at a conference titled Multilevel Interventions in Health Care: Building a Foundation for Future Research (Las Vegas, NV, March 4–5, 2011). Comments from that conference led to the final articles presented in this issue. The purpose of this article is to describe the relationship between the research articles and the conference to provide richer context for this monograph. We include a summary of the conference events to reflect the complementary development of the articles, to promote more open discussion of the issues among researchers, and to acknowledge the contribution of the meeting participants. In addition, this article summarizes the history behind the conference, its structure, the themes that developed there, and efforts that began after the conference to encourage discussion about multilevel interventions.

This summary reflects on this monograph regarding multilevel intervention (MLI) research to 1) assess its added value; 2) discuss what has been learned to date about its challenges in cancer care delivery; and 3) identify specific ways to improve its scientific soundness, feasibility, policy relevance, and research agenda. The 12 submitted chapters, and discussion of them at the March 2011 multilevel meeting, were reviewed and discussed among the authors to elicit key findings and results addressing the questions raised at the outset of this effort. MLI research is underrepresented as an explicit focus in the cancer literature but may improve implementation of studies of cancer care delivery if they assess contextual, organizational, and environmental factors important to understanding behavioral and/or system-level interventions. The field lacks a single unifying theory, although several psychological or biological theories are useful, and an ecological model helps conceptualize and communicate interventions. MLI research designs are often complex, involving nonlinear and nonhierarchical relationships that may not be optimally studied in randomized designs. Simulation modeling and pilot studies may be necessary to evaluate MLI interventions. Measurement and evaluation of team and organizational interventions are especially needed in cancer care, as are attention to the context of health-care reform, eHealth technology, and genomics-based medicine. Future progress in MLI research requires greater attention to developing and supporting relevant metrics of level effects and interactions and evaluating MLI interventions. MLI research holds an unrealized promise for understanding how to improve cancer care delivery.

Multilevel intervention research holds the promise of more accurately representing real-life situations than single-level intervention research and, thus, with the proper research design and measures, being more likely to facilitate the effective and efficient resolution of complex health-care systems problems (1–3). Taking a multilevel approach to cancer care interventions, however, creates measurement challenges and opportunities. Some measurement issues are similar to those arising in single-level interventions, whereas some are unique to multilevel interventions (4,5). The purpose of this article is to examine the state of measurement in multilevel cancer intervention research and to suggest how opportunities in the field may be addressed by drawing on the measurement literature in other fields. One of the unique aspects of measurement in multilevel intervention research is that consideration of within and between level effects is needed. For multilevel interventions, it is not sufficient to measure effects at the different levels of intervention (eg, patient and health-care team), cross-level effects must also be taken into consideration (eg, the effect of patients on the team and the team on the patients). Furthermore, some measurement issues may be more complex when conducting multilevel intervention research, and some measurement rules of thumb may be uniquely associated with specific levels of analysis (eg, group or organization levels of analysis) (6,7). Because multilevel interventions are based on systems theory [whether general systems (8–10), social ecological systems (11,12), or complex adaptive systems (13) models], they require identification of key constructs and measures by level and consideration of interactions within and across levels (6). Thus, multilevel intervention research benefits from thoughtful planning and design, an interdisciplinary approach, mixed methods (eg, a combination of objective factors, surveys, interviews, observations) measurement and analysis, and careful attention to the congruence of theory, constructs, and measures. Through a systematic review of the literature, this article examines the state of measurement in multilevel cancer care intervention research, identifies measurement opportunities in the field, and draws upon other fields to provide direction about measures and measurement to multilevel cancer care intervention researchers.

Purpose We surveyed cancer physicians to understand how patients' age and comorbidity influence adjuvant chemotherapy recommendations and whether physician or practice characteristics also affect these recommendations. Methods National survey of surgeons and medical oncologists caring for patients with colorectal cancer regarding whether they would recommend adjuvant chemotherapy for hypothetical patients with stage III colon cancer who varied by age (55 v 80 years) and comorbid illness (none, moderate, severe congestive heart failure [CHF]). Repeated measures logistic regression was used to assess the influence of patient, physician, and practice characteristics on chemotherapy recommendations. Results Of 1,096 physicians, nearly all recommended chemotherapy for patients who were 55 years old with no comorbidity (99.0%), 55-years old with moderate CHF (88.6%), or 80 years old with no comorbidity (92.6%); many fewer recommended chemotherapy for 55-year-old patients with severe CHF (24.9%) or 80-year-old patients with moderate (47.2%) or severe (9.0%) CHF (P < .001). Younger physicians (P < .001) were more likely than others to recommend adjuvant chemotherapy overall, although physician factors explained little of the variability in recommendations. Conclusion Physicians agree with guidelines recommending adjuvant chemotherapy for young, healthy patients with stage III colon cancer but differ widely on recommendations for patients who are older and sicker. Few physician or practice characteristics were associated with recommendations. For older and sicker patients, the individual physicians seen may have a substantial impact on the likelihood of receiving chemotherapy. Understanding better the sources of variation not explained by patients' clinical characteristics may allow improved tailoring of therapy to patients most likely to benefit.

The use of performance measurement to inform macro-level studies of cancer control and quality of care is receiving increasing interest at the state, national, and international level. This article describes the use of these measures to inform health policy and monitor cancer disparities and disease burden. Applications are discussed in clinical and provider-reported outcomes such as cancer incidence, mortality and survival, and outcome-linked processes of care, and patient-reported outcomes such as health-related quality of life and patient satisfaction/experience with care. The use of economic measures to monitor and evaluate the burden of illness is also discussed. The growing demand for surveillance capability coupled with the need to expand both the quality and breadth of available measure sets, suggests that there is a need to supplement traditional clinical and provider-reported process and outcomes measures with patient-reported outcomes measures such as health-related quality of life and patient satisfaction and experience with care. In addition, there is also a need to broaden and standardize outcome-linked process-of-care measures to improve the ability to measure and monitor incremental progress in improving cancer care. Finally, better measures of indirect costs of cancer care, such as loss productivity and caregiver burden among the aged, would improve national estimates of the cost of illness associated with cancer.

Background: Population trends in aging and improved cancer survival are likely to result in increased cancer prevalence in the United States, but few estimates of the burden of illness among cancer survivors are currently available. The purpose of this study was to estimate the burden of illness in cancer survivors in a national, population-based sample. Methods: A total of 1823 cancer survivors and 5469 age-, sex-, and educational attainment-matched control subjects were identified from the 2000 National Health Interview Survey. Multiple measures of burden, including utility, a measure of health, and days lost from work, were compared using two-sided tests of statistical significance for the two groups overall and for subgroups stratified by tumor site and time since diagnosis. Results: Compared with matched control subjects, cancer survivors had poorer outcomes across all burden measures (P

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.

Clinical trials in oncology are essential to establish the effectiveness of new therapeutic strategies. However, a recent Institute of Medicine report described an impending crisis in cancer clinical trials, raising concerns about the complexity of requirements for conducting trials, appropriate prioritization of trial proposals, cost, and low accrual rates (1). Up to 40% of National Cancer Institute (NCI) sponsored trials close without meeting accrual goals (1), and nearly one-third of phase III trials close because of poor accrual (2). Clinical trial enrollment rates in adult cancer populations have historically been 5% or less (1,3,4), with lower rates among minorities and older patients (4–10). An important factor in determining whether patients participate in clinical trials is whether their health care providers discuss the option of participation (1). However, there is limited information regarding rates of discussions about participation, sources of patient information about trials, and the association of patient characteristics with these factors. One study of 235 patients and their physicians found that only 20% of patients potentially eligible for phase II/III trials were offered enrollment, yet most who were offered enrollment participated. Shared decision-making between patient and physician about trial enrollment was associated with the decision to enroll (11). However, this was a small study of patients at two NCI-designated comprehensive cancer centers, which may limit its generalizability. A previous study from the large, population- and health-system-based, multiregional Cancer Care Outcomes Research and Surveillance (CanCORS) (12) Consortium reported that 5.3% of patients with lung or colorectal cancer participated in clinical trials within 14 months of diagnosis (3). This study found that younger age and stage III /IV disease, but few other patient factors, were associated with clinical trial participation (3). That analysis, however, focused primarily on associations between physician characteristics and trial enrollment. It did not address discussions with physicians about the possibility of enrollment or the patient decision-making process around trials. In this study, we used additional data from the CanCORS study to better understand how patients with newly diagnosed lung or colorectal cancer decided whether to participate in clinical trials. We first assessed the proportion of patients who discussed clinical trials as a potential treatment option and examined demographic characteristics, beliefs, and clinical factors associated with these discussions. Second, among patients who discussed clinical trials as a treatment option, we further assessed participation rates and demographic characteristics, beliefs, and clinical or decision-making process factors associated with patients’ decisions to participate. We also assessed discussion and participation rates among patients who saw oncologists, received chemotherapy, and were treated with chemotherapy for advanced disease, for whom more trials may have been available. Next, we examined the sources from which clinical trial participants first learned about the trials in which they participated, and from which nonparticipants learned that a clinical trial was a possibility. Finally, we evaluated the main reasons for declining to participate among nonparticipants.

Purpose High-quality supportive care is an essential component of comprehensive cancer care. We implemented a patient-centered quality of cancer care survey to examine and identify predictors of quality of supportive care for bowel problems, pain, fatigue, depression, and other symptoms among 1,109 patients with colorectal cancer. Patients and Methods Patients with new diagnosis of colorectal cancer at any Veterans Health Administration medical center nationwide in 2008 were ascertained through the Veterans Affairs Central Cancer Registry and sent questionnaires assessing a variety of aspects of patient-centered cancer care. We received questionnaires from 63% of eligible patients (N = 1,109). Descriptive analyses characterizing patient experiences with supportive care and binary logistic regression models were used to examine predictors of receipt of help wanted for each of the five symptom categories. Results There were significant gaps in patient-centered quality of supportive care, beginning with symptom assessment. In multivariable modeling, the impact of clinical factors and patient race on odds of receiving wanted help varied by symptom. Coordination of care quality predicted receipt of wanted help for all symptoms, independent of patient demographic or clinical characteristics. Conclusion This study revealed substantial gaps in patient-centered quality of care, difficult to characterize through quality measurement relying on medical record review alone. It established the feasibility of collecting patient-reported quality measures. Improving quality measurement of supportive care and implementing patient-reported outcomes in quality-measurement systems are high priorities for improving the processes and outcomes of care for patients with cancer.

e18234Background: PCORI funds comparative clinical effectiveness research (CER) that aims to produce evidence-based information to help people make informed health care decisions and improve outcom...

279 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) was designed to improve care and reduce cancer disparities at community hospitals. This study examined the number of days between diagnosis and treatment for five National Quality Forum-endorsed cancer quality measures. Methods: A retrospective analysis of data from patients diagnosed and receiving breast or colon cancer treatment at 12 NCCCP sites was performed. We examined time to treatment for cancer quality measures, stratified by concordant and non-concordant patients. We compared patients diagnosed before (2006 – 2007) vs. during (2008-2013) the NCCCP period. Results: Concordant Cases. Time to treatment was significantly greater in the NCCCP vs. pre-NCCCP periods for three measures. Compared to pre-the NCCCP period, time to treatment in the NCCCP period was longer by 26 days for women with breast cancer receiving hormonal therapy (HT). Time to HT increased significantly among most patient and hospital subgroups (race, age, insurance, hospital size). Black, Medicaid, and/or uninsured patients generally had longer-than-average time to treatment for all measures when receiving guideline-concordant care. Non-Concordant Cases. Among women with breast cancer who received treatment outside the measure window, most eligible for multi-agent chemotherapy received treatment within one month after the cut-off. In contrast, a majority eligible for other cancer quality measures received treatment more than one after the cut-off. Among women who were non-concordant for HT, those with Medicare or private insurance were significantly more likely to begin HT within one month after the cut-off than were those with Medicaid. Conclusions: More than half of patients non-concordant on cancer quality measures received treatment more than one month after the treatment window. However, many were non-concordant because they were just outside the time window to be considered concordant (< 30 days), particularly Medicaid patients. Rapid reporting of quality indicators could inform targeted efforts to improve care coordination and concordance rates, particularly among certain patient subgroups.

74 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) was designed to improve the quality of cancer care and reduce disparities at hospital-based community cancer centers. This study examined when guideline-concordant therapy was considered but not administered, who made the decision to not receive treatment. Methods: A retrospective analysis of patients diagnosed and receiving all or part of their initial cancer treatment at one of 12 NCCCP sites was conducted. We examined patients who were guideline-concordant with the hormonal therapy (HT) for breast cancer quality measure, but for whom treatment was considered but not administered. We compared patients diagnosed in the pre-NCCCP period (2006 – 2007) and during the NCCCP period (2008-2013). Results: Overall, a low proportion of cases had HT considered but not administered (4% in pre-NCCCP period; 5% in NCCCP period – difference not significant). In the pre-NCCCP period, white patients were twice as likely as Black patients to have HT considered but not administered, while there were no racial differences during the NCCCP period. In both time periods, older patients and Medicare patients were more likely to have HT considered but not administered. The most common reason for considering but not administering HT was refusal by the patient or patient’s family and this more likely for White patients, patients in the middle age groups (50-59 and 60 to 69), and Medicare patients. The second most common reason was that the physician determined it to be contraindicated due to patient risk factors. This was more likely to be a reason for Black and Medicaid patients. Conclusions: Results show that a large proportion of cases that had treatment considered but not administered did not receive treatment because of patient/family refusal or it was contraindicated due to other patient risk factors, both before and during the NCCCP period. Additional studies could inform the long-term outcomes of patients with comorbid conditions who were considered for guideline-concordant treatment but did not receive it (but the data were not available for this study).

The social ecological perspective provides a compelling justification for multilevel intervention. Yet, it offers little guidance for selecting interventions that work together in complementary or synergistic ways. Using a causal modeling framework, we describe five strategies for increasing potential complementarity or synergy among interventions that operate at different levels of influence: accumulation, amplification, facilitation, cascade, and convergence. We illustrate these strategies with examples of multilevel interventions to improve the quality of cancer treatment.

BACKGROUND: Few studies have measured longitudinal changes in health-related quality of life (HRQOL) among patients with prostate cancer starting before their cancer diagnosis or have provided simultaneous comparisons with a matched noncancer cohort. In the current study, the authors addressed these gaps by providing unique estimates of the effects of a cancer diagnosis on HRQOL accounting for the confounding effects of ageing and comorbidity. METHODS: Data from the Surveillance, Epidemiology, and End Results registry were linked with Medicare Health Outcomes Survey (MHOS) data. Eligible patients (n = 445) were Medicare beneficiaries aged ≥65 years from 1998 to 2003 whose first prostate cancer diagnosis occurred between their baseline and follow-up MHOS. By using propensity score matching, 2225 participants without cancer were identified from the MHOS data. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey and the activities of daily living scale. RESULTS: Before diagnosis, patients with prostate cancer reported HRQOL similar to that of men without cancer. After diagnosis, men with prostate cancer experienced significant decrements in physical, mental, and social aspects of their lives relative to controls, especially within the first 6 months after diagnosis. For men who were surveyed beyond 1 year after diagnosis, HRQOL was similar to that for controls. However, an increased risk for major depressive disorder was observed among men who received either conservative management or external beam radiation. CONCLUSIONS: The current findings illustrated the time-sensitive nature of decline in HRQOL after a cancer diagnosis and enhanced understanding of the impact of prostate cancer diagnosis and treatment on physical, mental, and social well being among older men. Cancer 2012. © 2012 American Cancer Society.

Purpose We assessed cancer survivors' perceptions of the quality of their follow-up care. Methods We surveyed a population-based cohort of leukemia, bladder, and colorectal cancer survivors diagnosed 2 to 5 years previously in northern California (N = 623; participation rate, 69.2%; overall response rate, 49.2%). Data were collected between April 2003 and November 2004. Ten scales assessed survivors' perceptions of different aspects of care in the last 12 months, and an eleventh scale measured their overall ratings of care. Results On nine of the 11 scales, mean scores ranged from 88 to 97 on a 0 to 100 response format, indicating very positive experiences. The two areas where quality perceptions were lower were discussions about health promotion and the physician's knowledge of the whole patient. In adjusted analyses, those without private health insurance (P = .02) and Hispanic and Asian survivors compared with whites (P < .001) reported worse timeliness of care. Survivors who had multiple comorbidities reported better scores on timeliness of care (P < .01) and physicians' knowledge (P = .05) than survivors without any comorbidity. Length of the patient-physician relationship was the variable most consistently found to be significantly associated with survivors' quality assessments. Physicians' information exchange had the strongest relationship with overall ratings of care, followed by physicians' affective behavior, their knowledge of the survivor, and survivors' perceptions of coordination of care (P < .001 for all). Conclusion Delivery of quality follow-up care to cancer survivors may require efforts to improve patient-centered communication and coordination. Special emphasis may need to be placed on health promotion discussions and adoption of a whole-person orientation.

Quality cancer treatment depends upon careful coordination between multiple treatments and treatment providers, the exchange of technical information, and regular communication between all providers and physician disciplines involved in treatment. This article will examine a particular type of organizational structure purported to regularize and streamline the communication between multiple specialists and support services involved in cancer treatment: the multidisciplinary treatment care (MDC) team. We present a targeted review of what is known about various types of MDC team structures and their impact on the quality of treatment care, and we outline a conceptual model of the connections between team context, structure, process, and performance and their subsequent effects on cancer treatment care processes and patient outcomes. Finally, we will discuss future research directions to understand how MDC teams improve patient outcomes and how characteristics of team structure, culture, leadership, and context (organizational setting and local environment) contribute to optimal multidisciplinary cancer care.

BACKGROUND: The impact of cancer on health-related quality of life (HRQOL) is poorly understood because of the lack of baseline HRQOL status before cancer diagnosis. To our knowledge, this is the first population-based study to quantify the nature and extent of HRQOL changes from before to after cancer diagnosis for nine types of cancer patients and to compare their health with individuals without cancer. METHODS: The Surveillance, Epidemiology, and End Results cancer registry data were linked with the Medicare Health Outcomes Survey (MHOS) data; data were collected from Medicare beneficiaries who were aged 65 years and older from 1998 through 2003. Cancer patients (n = 1432; with prostate, breast, colorectal, lung, bladder, endometrial, or kidney cancers; melanoma; or non-Hodgkin lymphoma [NHL]) were selected whose first cancer diagnosis occurred between their baseline and follow-up MHOS assessments. Control subjects without cancer (n = 7160) were matched to cancer patients by use of propensity scores that were estimated from demographics and comorbid medical conditions. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey (mean score = 50, SD = 10). All statistical tests were two-sided. RESULTS: Patients with all cancer types (except melanoma and endometrial cancer) reported statistically significant declines in physical health (mean scores: prostate cancer = -3.4, 95% confidence interval [CI] = -2.5 to -4.2; breast cancer = -3.5, 95% CI = -2.5 to -4.5; bladder cancer = -4.3, 95% CI = -2.5 to -6.1; colorectal cancer = -4.4, 95% CI = -3.3 to -5.5; kidney cancer = -5.7, 95% CI = -3.2 to -8.2; NHL = -6.7, 95% CI = -4.4 to -9.1; and lung cancer = -7.5, 95% CI = -5.9 to -9.2) compared with the control subjects (mean score = -1.8, 95% CI = -1.6 to -2.0) (all P < .05). However, only lung (mean score = -5.4, 95% CI = -3.5 to -7.2), colorectal (mean score = -3.5, 95% CI = -2.2 to -4.7), and prostate (mean score = -2.8, 95% CI = -1.8 to -3.7) cancer patients showed statistically significant decreases in mental health relative to the mean change of the control subjects (mean score = -1.2, 95% CI = -0.9 to -1.4) (all P < .05). CONCLUSION: These findings provide validation of the specific deleterious effects of cancer on HRQOL and an evidence base for future research and clinical interventions aimed at understanding and remediating these effects.

BACKGROUND. The Institute of Medicine (IOM) report Crossing the Quality Chasm proposed 6 aims for high-quality healthcare: effective, safe, timely, efficient, equitable, and patient-centered, and emphasized care coordination. Through interviews with nationally recognized experts in healthcare quality, perspectives on barriers and facilitators to achieving these aims for cancer patients were elicited. METHODS. In all, 23 peer-nominated experts with diverse backgrounds in policy, healthcare, patient advocacy, and research were individually interviewed. They were asked about barriers and facilitators to achieving high-quality cancer care, and information technology or other innovations that might improve the quality of cancer diagnosis, treatment, and surveillance. Interviews were tape-recorded and transcribed. Two analysts independently reviewed and coded each transcript using ethnographic software to elucidate key themes. RESULTS. The major perceived barrier to providing high-quality cancer care was unnecessary variation in cancer care because of lack of standardization or adherence to guidelines during diagnosis, treatment, and surveillance. Additional barriers included insufficient teamwork and communication among multidisciplinary care teams, lack of patient awareness and empowerment, diagnostic delays during provider transitions, and excessive reimbursement for treatment. Experts suggested improving cancer patients' experiences by standardizing care, adhering to guidelines, and using “patient navigators” and an interoperable electronic medical record accessible to patients and providers at multiple facilities. CONCLUSIONS. Some of these solutions have been developed and tested, whereas others have not. It is hoped that these suggestions provide impetus for new research, accelerating progress toward achieving the IOM's vision for high-quality cancer care. Cancer 2008. © 2008 American Cancer Society.

10 Background: PCORI funds comparative effectiveness research (CER) which aims to produce evidence-based information to help people make informed health care decisions and improve outcomes that matter to patients. Cancer studies form one of the largest disease-specific PCORI-funded portfolios. Methods: We conducted a systematic analysis of PCORI’s cancer portfolio overall and of the subset of studies that focus on post-treatment survivorship. Results: As of June 2015, PCORI has funded 47 cancer projects totaling $125 million. Cancer studies account for 17% of PCORI’s dollar investment in CER research. These studies have focused on breast, lung, prostate, colorectal, cervical, ovarian, and pancreatic cancers as well as leukemia. A majority of PCORI-funded cancer studies are randomized trials (60% of studies, 72% of dollar investment). One-in-four studies address post-treatment survivorship (n = 12, $23 million). The 12 CER studies on post-treatment survivorship address a range of patient-centered issues. Four studies are evaluating different post-treatment surveillance approaches for breast (2 studies), colorectal, and lung cancer survivors respectively. Three studies are focusing on optimizing the care planning process for cancer survivors while another is evaluating the impact of an oncology medical home model on patient-centered outcomes. Four studies are addressing quality of life (QOL) issues, one is evaluating approaches for incorporating patient reported outcomes data in the clinical encounter, a second is evaluating a multi-component intervention to improve the QOL of cancer survivors, a third study is evaluating the comparative effectiveness of complementary therapies to treat symptoms, and another is addressing distress among caregivers of stem cell transplant survivors. Conclusions: PCORI-funded CER studies are rigorously evaluating the real world impact of a range of interventions aimed at optimizing the quality of care delivered to and outcomes experienced by cancer survivors. Our analysis of the cancer portfolio will inform future funding priorities aimed at improving patient-centered outcomes for cancer survivors.

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.

To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit.Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006).Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

If the central business of cancer outcomes research is the pursuit of information relevant to a range of decision makers (1), i.e., patients, families, providers, payers, regulators, standards setters, and researchers, several questions quickly arise. What is the nature and scientific quality of the information currently being produced? How do we enhance the rigor and relevance of cancer outcomes research, with a concern not only for the methodological and empirical foundations but also its potential and actual contributions to decision making? What is the research agenda to carry us forward? The preceding 10 papers of this Monograph sought to address the first question above—the quality of the information— through empirically grounded reviews and evaluations of the published literature. This final paper, authored by staff at the National Cancer Institute (NCI), examines aspects of the remaining questions. It identifies the elements of a research agenda intended to generate better scientific products and information to enhance the quality of cancer care decision making and ultimately the quality of cancer care. We have said that the purpose of cancer outcomes research is to describe, interpret, and predict the impact of interventions and also other influences on “final” outcomes that matter to decision makers (1). Such outcomes include not only survival and disease-free survival but also important nonbiomedical, patientreported outcomes such as health-related quality of life (HRQOL), patient perceptions of and satisfaction with health care, and the economic burden attributable to cancer and its interventions. Final outcomes are distinguished from both intermediate outcomes (e.g., appropriate cancer screening) and clinical outcomes (e.g., delay in tumor progression), which are frequently the direct targets of, and indicators of success for, cancer interventions. However, the importance of intermediate and clinical outcomes for cancer decision making rests ultimately on the extent to which they can be convincingly linked to improvement in final outcomes such as a reduction in mortality. In order for outcomes research to achieve its potential to improve cancer care delivery, three prerequisites apply: 1) technically sound and decision-relevant final outcome measures; 2) persuasive evidence about the effect of interventions on those outcomes, with due attention to the causal linkages among intermediate, clinical, and final outcomes; and 3) the willingness and ability to translate findings into information that decision makers find understandable and compelling. This Monograph has employed a tripartite framework for categorizing and characterizing the arenas of application for cancer outcome measures; see Table 1 here and its more expansive counterpart in the paper that introduces the Monograph (1). Macro-level studies chart population trends in cancer-related outcomes and progress against the cancer burden. Meso-level studies investigate the impact of cancer and cancer-related interventions on outcomes, with a focus (depending on the study’s specific purpose) on determining the efficacy of candidate interventions under controlled circumstances or in the community; describing patterns of cancer care, including the extent to which quality-enhancing services are embraced; or identifying effective or cost-effective interventions in the context of program evaluations or priority-setting analyses. Interventions include not only specific cancer prevention, detection, or treatment services or programs but also changes in the organization, financing, or delivery of cancer care that may influence outcomes. Micro-level studies examine the use of cancer outcome measures and measurement tools to enhance the quality of information available for patient–clinician decision making. There is no intent here to imply that the topic areas in Table 1 are to be regarded as subsets or components of some larger, all-encompassing enterprise called “cancer outcomes research.” Rather, we seek to show how the latter can contribute substantially to a variety of analyses within each of these arenas, especially regarding the measurement of outcomes that matter to decision makers. Because this paper attempts to identify not only the major opportunities and challenges confronting cancer outcomes research but also specific pathways forward in a number of domains, it takes the form of an extended, multipart essay rather than a summary document that only highlights the tasks ahead. While the sections and subsections below proceed in a sequence that we believe is natural and cumulative, they can be pursued in any order or even selectively, depending on reader interest. That said, the remaining sections focus in turn on

182 Background: The NCI Community Cancer Center Program (NCCCP) pilot launched in 2007 to improve quality and reduce disparities in patients receiving care in community hospital-based cancer centers. This study assessed the percent improvement in guideline-concordant cancer care since NCCCP initiation, overall and for disparate patient populations. Methods: We conducted a retrospective analysis of patients diagnosed and receiving treatment at one of 12 NCCCP sites. We compared percent improvement in concordance for NQF-approved quality measures: 3 breast (BCS-radiation following breast conserving surgery; HT-hormonal therapy; and MAC-multi-agent chemotherapy) and 2 colon (12RLN-12 regional lymph nodes examined during surgery; and ACT-adjuvant chemotherapy). Sample included patients diagnosed 2006 to 2007 (baseline, or pre-NCCCP) and 2008 to 2013 (NCCCP). Percent improvement was defined as the difference in concordance between baseline and NCCCP periods divided by baseline concordance. Results: Between baseline and NCCCP periods, improvement was noted for all 5 measures. The HT concordance rate improved by 55.1% (from 58.2% to 90.3%). For all breast measures, Black patients showed significantly larger than average percent improvement (p

180 Background: Symptom management is critical to quality cancer care, affecting treatment completion, functioning and quality of life. We describe the use of the Commission on Cancer’s Rapid Quality Reporting System (RQRS) to ascertain cases for PRO collection, identify key PRO quality indicators, and provide actionable symptom management quality improvement (QI) reports to community cancer centers (CCC). Methods: The Patient Reported Outcomes Symptoms & Side Effects Study used RQRS to sample patients (pt) 4-12 months from diagnosis with locoregional breast/colon from 17 National Cancer Institute Community Cancer Centers Program centers. Surveys were mailed with web option. Pts were asked if they talked to a health professional about pain (Talk about) and, separately, if the health professional gave advice about what to do if pain started, got worse, or came back (Advice). Similar questions were asked about fatigue and emotional distress (ED). QI reports were designed with CCC staff feedback and produced for each CCC providing crude and case-mix adjusted CCC-specific rates, and study-wide rates. Direct standardization methods were used to adjust CCC-specific rates for cancer type and education. Results: 2,487 eligible participants responded (RR=61%). This table shows overall study-wide estimates and the range of adjusted CCC-specific estimates for six key indicators. (See Table.) Conclusions: This pilot study shows the registry-based method for PRO collection was successful and has potential for wider dissemination. Study-wide, 20-45% of pts did not report discussing or getting advice about three common symptoms from their healthcare team. CCCs varied significantly on these indicators, suggesting room for improvement. Quality reports were well received by hospital staff, who report sharing them with clinicians, navigators and cancer committees. CCC-specific reports may promote efforts to improve care through professional/patient education and applying standards of care. [Table: see text]

6509 Background: Clinical trials are essential for evaluating new cancer therapies, but less than 5% of adults with cancer enroll in trials. Barriers to enrollment may include patient-provider communication factors, such as lack of patient awareness or understanding about the option of participation. Methods: We surveyed a population- and practice-based sample of patients (or their surrogates) 3 to 6 months after diagnoses of lung or colorectal cancer. We assessed whether respondents learned that clinical trial participation might be an option, and if so, with whom they first discussed this possibility. We used multivariable logistic regression to assess the association of patient characteristics with clinical trial discussions and enrollment. Results: Of 7,887 respondents, 1,114 (14.1%) reported discussing clinical trial participation. Most (92.7% of participants, 75.8% of nonparticipants) learned about trials from their physicians. 287 patients (3.6% of all patients, 25.8% of trial discussants) enrolled...

6536 Background: In 2007, the NCCCP pilot program launched with 16 sites and a goal to improve quality of care, reduce cancer disparities and increase participation in clinical trials. In 2008, NCC...

In recent years, there has been a growing interest in incorporating patients’ perspectives when measuring and interpreting the clinical benefit of cancer therapies. Patient-reported outcomes (PROs) are used in a variety of cancer clinical trials. These studies range from using PROs to better understand the burden of cancer and the adverse effects of cancer therapy (such as pain), to studies that use PROs as the primary end point of the clinical trial, such as reducing symptoms like nausea or fatigue that can be caused by certain cancer therapies. The evolution of PROs in cancer trials has been recently documented by the National Cancer Institute (NCI)–supported Cancer Outcomes Measurement Working Group and by the US Food and Drug Administration’s recent guidance for the use of PROs in product labeling. PRO research also has been recognized as an important element in the NCI strategic planning process. A major NCI goal is to support research that enhances our understanding of the burden of disease among patients with cancer and cancer survivors, and reduces the sequellae of cancer throughout the continuum of care. NCI has taken an important role in developing new ways to measure patient-reported symptoms such as pain and fatigue, and aspects of health-related quality of life across a wide range of cancers and other diseases, through the Patient Reported Outcomes Measurement Information System (PROMIS). As a National Institutes of Health Roadmap initiative, PROMIS will provide clinical research communities with a reliable, valid, and standardized approach to capture these clinically relevant, but subjective and difficult-to-measure outcomes in clinical trials. Standardization of these data will provide additional benefits to the cancer clinical trial enterprise because it will eventually facilitate their incorporation into the cancer bioinformatics grid (ca-BIG), thereby making PROs available to all researchers who participate in and use the grid to support correlative research studies in connection with clinical trials. Through the NCI Clinical Trials Working Group (CTWG), NCI also has undertaken a major reassessment of the design, review, funding, and implementation of cancer clinical treatment trials and symptom management trials. Among the many recommendations contained in the CTWG report are ones to establish a new funding mechanism and prioritization process for supporting correlative science and quality-of-life studies using PROs, that can be initiated in association with clinical trials. As part of the CTWG process, NCI recently created a Symptom Management and Health-Related Quality of Life (SxQOL) Steering Committee to prioritize and review studies that include PROs as primary end points in symptom management clinical trials, and PROs as secondary end points in phase III Cooperative Group cancer treatment trials sponsored by the NCI. In addition, the SxQOL committee will provide guidance on how to improve the utility of PROs in cancer treatment trials and in symptom management trials. Although PRO data have potential utility for a variety of analyses in cancer clinical trials, the issues surrounding their appropriate and effective application are complex. In September 2006, the NCI convened a 2-day conference entitled “PatientReported Outcomes Assessment in Cancer Trials (PROACT): Evaluating and Enhancing the Payoff to Decision-Making.” This conference was cosponsored by the American Cancer Society and represented a collaborative effort among the leadership from all major NCI extramural divisions involved with clinical trials—the Division of Cancer Treatment and Diagnosis, the Division of Cancer Prevention, and the Division of Cancer Control and Population Sciences. The goal of the PROACT conference was to bring together scientists working in this area to inform NCI and the broader cancer research and policy community on how the NCI clinical trial infrastructure is currently organized to support PRO research in clinical trials, and to identify the issues and lessons learned from the experiences of NCI-sponsored cooperative groups and Community Cancer Oncology Programs; other national and international researchers; and US pharmaceutical industry experts in using PROs in phase II and III cancer treatment trials, as well as in symptom management trials. Before the conference, NCI charged a multidisciplinary Scientific Program Committee of internationally recognized experts to identify key determinants of the successful application of PROs in JOURNAL OF CLINICAL ONCOLOGY O V E R V I E W VOLUME 25 NUMBER 32 NOVEMBER 1

178 Background: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) was initiated to expand cancer research and deliver quality cancer care in communities. A program goal was support of quality care initiatives. Twenty-one community sites in 16 states participated in the network providing care to approximately 40,000 cancer patients/year. We describe strategies for implementation of a structured quality program within our network. Methods: Four components served as the foundation for quality efforts: 1) increasing multidisciplinary care (MDC) programs; 2) ASCO QOPI participation; 3) Commission on Cancer Rapid Quality Reporting System (RQRS) participation; and 4) expansion of genetic counseling/services. A Quality of Care subcommittee formed to guide quality efforts within the network. Clinicians from the network served as subcommittee leadership and each site designated a quality of care lead. The subcommittee met by teleconference monthly, developed goals, shared best practices, developed processes to accomplish goals and documented improvements in priority areas. Results: Strategies employed to improve quality included: assessment tool development, participation in national quality reporting initiatives, review and monitoring of network data, and network performance improvement projects. Conclusions: The NCCCP identified areas of needed quality improvement. In addition, the network developed implementation strategies and created benchmarks that measure program quality. Participants benefitted from the opportunity to interface with one another and set network goals, while adopting strategies to best fit their own practices and community sites. [Table: see text]

103 Background: According to a landmark study by the Institute of Medicine, patients with cancer often receive poorly coordinated care in multiple settings from many providers. Lack of coordination is associated with poor symptom control, medical errors, and higher costs. The aims of this presentation are to: (1) describe the state-of-the science on cancer care coordination measures and intervention outcomes from a systematic review and meta-analysis of empirical papers published between 1980-2013; (2) explore the implications of these findings from the patient, provider, healthcare system, and national policy perspectives. No similar review has yet been published. Methods: Of 1,241 abstracts collected from a systematic search of PubMed, MeEMBASE, Medline, CINAHL, and Cochrane Library, 50 studies met the inclusion criteria. Each study had US or Canadian participants; comparison or control groups, measures, times, samples, and/or interventions. Two raters independently applied a standardized search strategy and coding scheme. Eight studies (14 outcomes) met the additional criteria for the meta-analysis. We used the Care Coordination Atlas (McDonald, 2010) definition of care coordination. Results: Overall, coordination improved cancer care across 83% (44) of the measured outcomes. Interventions led to more appropriate healthcare use (g = 0.37 [95% CI = 0.29 – 0.46]; I2= 0.00) across screening (patient navigation), treatment (home telehealth, nurse case management and education), and end-of-life care (early palliation). Measures varied considerably in psychometric quality and were limited in focus. They included; rates of guideline compliance (screening), timeliness of care (diagnosis), health-related quality of life (treatment), cancer-related distress (survivorship), and home death (end-of-life). Conclusions: The findings revealed effective interventions across the cancer continuum from screening to end-of-life. More, and better measures are needed across the cancer continuum. We discuss the implications of these findings for more and better measures, approaches to implement effective interventions in clinical settings, and to develop supportive policy (and reimbursement) contexts.

6536 Background: To our knowledge, no systematic review of empirical papers describing cancer care coordination interventions has yet been conducted. The aim of this presentation is to describe the methods and findings from a systematic review and meta-analysis of all empirical papers describing cancer care coordination published between 1990-2012. Methods: Of 1241 abstracts collected from a search of PubMed and EMBASE, 108 studies were retrieved and reviewed; 49 were included in the systematic review. Each study had US or Canadian adult or child participants; each paper had comparison or control groups, measures, samples, and/or interventions. Two researchers independently applied a standardized search strategy, coding scheme, and on-line coding program to each study. Eight RCT’s met additional criteria for meta-analysis; a random effects estimation model was used for data analysis. Results: Among the 49 articles included in our systematic review, those that included implicit or explicit definitions of cancer care coordination described four components: (1) roles and models for communication and transfer of care between primary care physicians and oncologists during active treatment and survivorship; (2) care navigation through designated personnel or telecommunication processes among care team members; (3) treatment summaries and survivorship care plans; and (4) multidisciplinary communication accompanying patient and practice management within the framework of the Chronic Care Model (N=14). We found a medium-sized effect of cancer care coordination on care usage outcomes among the randomized clinical trials (e.g., reduced Emergency Department visits; g = 0.37 [95% CI = 0.29 - 0.44], I2= .000. Fail-safe N = 86). Conclusions: The findings from this current systematic review and meta-analysis will contribute to the evidence base on strategies that can improve the coordination of cancer care, particularly for patients with multiple chronic conditions, and thereby advance the goals of health care reform in the US.

208 Background: The NCCCP is a network of community based institutions from New England to Hawaii funded by the NCI. Quality of care is a priority of the NCCCP with participation in ASCO’s Quality Oncology Practice Initiative (QOPI) playing a fundamental role. QOPI provides a process for quality assessment but we have also used it as a measure of quality improvement (QI) network-wide. Using QOPI methodology, we have analyzed our performance twice a year in an effort to enhance our implementation of quality indicators relevant to program aims. Methods: A data sharing agreement allows individual practice QOPI data to be electronically sent to the NCI where it is aggregated with the other NCCCP QOPI participants. Data are presented via webinar within the network using a variety of QI strategies. For example, blinded site performance distributions are benchmarked against NCCCP national averages on specific indicators. High performing practices voluntarily present their QI initiatives and best practices to the network. The NCCCP Quality of Care Subcommittee then selects QI projects and areas to focus quality improvement efforts. Results: In Spring 2012, 44 practices affiliated with 25 NCCCP sites participated in QOPI, a consistent pattern since Fall 2010. The table below describes the percent compliance with certain QOPI measures for the NCCCP aggregate over time. Selected measures were perceived as having had suboptimal compliance in Fall 2010. Conclusions: QOPI is an effective tool for assessing quality within a network and for measuring quality improvement efforts. Best practices from within the network can be leveraged and disseminated to enhance the quality of cancer care. This methodology facilitates quality initiatives despite the logistical challenges of working with practices across the country. [Table: see text]

67 Background: A key aim of the NCCCP is to develop and improve the quality of multidisciplinary care (MDC). An assessment tool with nine key elements relevant to MDC structure and operations was developed to assess MDC maturity and set goals for continued quality improvement at individual sites and across the network. Methods: 14 NCCCP sites self-reported MDC assessments for lung, breast, and colorectal cancer in June 2010, 2011, and 2012 using an online reporting tool. Each site evaluated their level of maturity (level 1 = no MDC, level 5 = highly integrated MDC) in nine elements integral to the MDC process. Qualitative review of sites’ responses was also conducted. Results: MDC improvement was most evident in four of nine elements; case planning (CP), physician engagement (PE), integration of care coordination (ICC), and quality improvement (QI). The number of sites at level 3 or greater is reported in the table below. Integration of primary care providers and increased organizational support contributed to improved CP. PE was related to conditions of participation, insuring involvement of appropriate physicians in the MDC. The network focus on patient navigation was demonstrated by increase of ICC. Improvement in QI was related to increased participation of sites in physician and hospital quality initiatives (i.e., QOPI and RQRS), and an NCCCP project aimed at increasing referrals to genetics for patient with breast and colon cancer. Conclusions: The maturity of MDC reflected focused work of the Quality of Care sub-committee of the NCCCP. The efforts of working groups in patient navigation, genetics and physician conditions of participation was made evident in the improved performance in MDC’s for three of the four most common malignancies seen in the United States. We hope that this work will provide a blueprint for other health systems that wish to incorporate multidisciplinary care into their cancer programs. [Table: see text]

9144 Background: NCI PRO-CTCAE is designed to enhance adverse event reporting by integrating patients’ self-report of the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic treatment toxicities. This study examined the construct validity of a subset of PRO-CTCAE items in women with metastatic breast cancer (MBC). Methods: 207 women (70% aged 45-59 years; 94% White;71% college-educated) with HER2+ MBC who had received treatment in the past month were recruited from 6 U.S. breast cancer support groups and completed a web survey that collected 18 PRO-CTCAE symptoms, and the Rotterdam Symptom Checklist (RSC). Pairwise concordance among PRO-CTCAE symptom dimensions was examined using weighted Kappa and Bowker’s test for symmetry. Results: Respondents were a median of 47 months since MBC diagnosis and 61% rated their health-related quality of life (HRQL) as good to excellent. Symptom prevalence was similar for PRO-CTCAE and RSC, with respondents more likely to endorse mood disturbance on PRO-CTCAE (Anxiety/Worry 90%; Sad/Unhappy Feelings 86%) vs. RSC (Anxiety 63%; Depressed Mood 61%). There was parallel rank-ordering of fatigue, anxiety, insomnia, depression, difficulty concentrating and neuropathy as the symptoms that were most severe, interfered most and caused the greatest bother. Within PRO-CTCAE, pairwise agreement among F, S and I was moderate for most symptoms (κw=.42 to .54). Agreement between F and S was highest for pain, nausea and arm/leg swelling (κw=.61 to .80), and lowest for anxiety/worry and sad/unhappy feelings (κw= .27-.37). Except for arm/leg swelling, endorsement patterns by the dimensions of F, S and I were distinct (Bowker’s p all

6086 Background: In 2007, NCI launched the NCCCP, a public-private partnership with 16 community hospital cancer centers in 14 states, to explore methods to improve patient access to advanced cancer care in the community. With 40% of its NCI funding directed to reduce disparities across the cancer continuum, the NCCCP aims to: 1) Enhance access to care; 2) Improve quality of care; and 3) Increase clinical trials accrual. This approach supports priorities in the 2009 ASCO Policy Statement: Disparities in Cancer Care. Methods: A disparities workplan was developed to support the three aims. NCI and the sites worked as a learning collaborative to develop strategies and metrics for: race and ethnicity data tracking; near real-time reporting of adherence to Commission on Cancer (CoC) treatment quality measures; community outreach and patient navigation to increase cancer screening; and improved clinical trial underserved accrual. The tools and resources supporting these efforts will be discussed. ( http://ncccp.cancer.gov/About/Progress.htm ). Results: Evaluation of the 3 year pilot shows improvement for underserved populations: Concordance with CoC treatment quality measures for radiation therapy for breast conserving surgery among Medicaid patients improved from 59.5 percent to 84.8 percent (p

e19633 Background: NCI PRO-CTCAE is a new patient-reported outcome measure designed to enhance adverse event (AE) reporting in clinical trials by integrating the patient experience. The PRO-CTCAE item bank includes items representing the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic AEs. The aim of this study was to examine the acceptability of a subset of PRO-CTCAE items to women receiving treatment for HER2+ MBC. Methods: 207 women on active treatment for HER2+ MBC (median 47 months since MBC diagnosis) were recruited from 6 U.S. breast cancer support groups and completed a web survey that included 18 PRO-CTCAE symptoms. Respondents were aged 45-64 years (71%), white (94%), college-educated (72%), with health-related quality of life rated good to excellent (61%) and median EQ5D utility score of 0.8. To explore PRO-CTCAE acceptability and data quality, we examined item level missingness, endorsement frequencies and binary and free-text responses about the comprehensibility of PRO-CTCAE items. Results: Item level missingness across all symptoms for each PRO-CTCAE dimension (F, S and I) ranged from 1.0% to 5.3%, with a median of 2.9%; interference associated with decreased appetite had the greatest missingness (5.3%). Excluding this outlier, maximum missingness was 3.9%. Endorsement frequencies of response choices for S of insomnia, constipation, fatigue, pain, anxiety/worry and sad/unhappy feelings support acceptable instrument sensitivity (all adjacent response points endorsed by >7% of respondents). Most respondents (92%) thought the items were easy to understand; a few were uncertain about how to rate symptoms such as anxiety, depression, insomnia and nausea if they were present but partially controlled with medication. Conclusions: These findings confirm and extend those of other studies demonstrating the acceptability of PRO-CTCAE. Evaluation in a more heterogeneous sample, particularly with respect to education and cancer site, is underway.

e16532 Background: The NCCCP is a consortium of 30 community based institutions funded by the NCI. Quality of care has been a priority of the NCCCP with participation in the Quality Oncology Practice Initiative (QOPI) serving as a fundamental element in those efforts. QOPI provides both a metric for baseline assessment and a means for measuring improvement across the network. Participation in QOPI became required with expansion of the NCCCP in 2010. Utilizing QOPI methodology, we describe our efforts to optimize adherence to fertility preservation standards of care. NCI Contract No. HHSN261200800001E Methods: A data sharing agreement allows individual practice performance to be electronically forwarded to the NCI twice a year where it is aggregated with the other NCCCP QOPI participants. This allows for ongoing evaluation of group statistics as well as comparisons between participating institutions. Those practices scoring highest on individual parameters are queried for best practices. Results: In Spring 2011, 38 practices/23 NCCCP sites participated resulting in 2653 chart reviews. 258 charts were applicable to fertile individuals as defined by QOPI. 46 charts were in compliance with suggested standards (17.8%) compared with the national rate of 26.1%. Four practices performed well above the national average and became the NCCCP's leaders for establishing best practices. The NCCCP then embarked upon a process of defining barriers to compliance with the fertility preservation recommendations, created an assessment tool by which each practice could identify the degree it integrated fertility preservation into their care models, and began the process of integrating nationally available educational materials and speakers. QOPI metrics will be used to measure the impact of these interventions. Conclusions: QOPI is a useful tool for measuring quality within a network, identifying barriers to compliance with ASCO fertility preservation recommendations and assessing quality improvement efforts. This methodology has allowed us to proceed with quality initiatives despite the logistical challenges of working with institutions and physicians from Maine to Hawaii.

6046 Background: The NCCCP pilot is an initiative designed to enhance research and improve cancer care at community hospitals. As part of a multi-method evaluation of this pilot, we assessed changes in quality of care among the 16 pilot NCCCP hospitals over time (before vs. after program initiation) and in comparison to a group of 25 similar hospitals that did not participate in the NCCCP. Methods: We compared changes in 5 NQF-approved quality of care measures (3 for breast cancer, 2 for colon cancer) from 2006/07 (before NCCCP initiation) vs. 2008/09/10 (post-initiation) for NCCCP and comparison group hospitals. Data were collected from all study hospitals using the Commission on Cancer’s Rapid Quality Reporting System, which allowed near real-time tracking of quality of care process measures. Results: Analyses included 18,608 breast cancer and 7,031 colon cancer patients. Patient-level concordance rates for all 5 quality of care measures increased significantly among both NCCCP and comparison group hospitals. The change (from baseline to post-NCCCP) in quality of care among NCCCP hospitals was significantly greater than the change among comparison group hospitals for two measures: radiation therapy following breast conserving surgery (RT-BCS) and hormonal therapy for women with hormone receptor positive breast cancer (HT). For the RT-BCS measure, NCCCP patients from underserved populations also experienced significantly greater changes in concordance than did corresponding populations from comparison group hospitals. In multivariate regression analyses controlling for patient characteristics, the change for the HT measure among NCCCP hospitals was significantly greater than that among comparison group hospitals. Conclusions: While both NCCCP and comparison group hospitals showed improved quality of care, participation in the NCCCP was associated with significantly greater improvements for a subset of measures. Including a separate comparison hospital group was critical for assessing changes associated with NCCCP participation while controlling for broader U.S. trends in improved quality of care. Future work will examine how hospital networks may have facilitated improvements in quality of care.

9047 Background: Symptomatic adverse events (AE) in cancer trials are reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective into AE reporting, NCI contracted (HHSN261201000043C) to create a patient-reported outcomes companion tool (PRO-CTCAE). We report the validity and reliability of PRO-CTCAE’s 124 items reflecting 78 symptomatic AEs. Methods: English-speaking subjects (n=869; 44% male; median [mdn] age 59; 32% racial/ethnic minority; 34% high school or less; 17% ECOG Performance Status [PS] 2-4) receiving treatment for a range of cancers at 4 NCI-designated cancer centers and 5 sites in NCI's Community Cancer Centers Program completed a web-based survey in clinic including PRO-CTCAE and EORTC QLQ-C30. Pearson correlations were computed between PRO-CTCAE items and QLQ-C30 scales. Differences in PRO-CTCAE item scores between clinician-reported ECOG PS (0-1 vs 2-4) groups were computed. Test-retest reliability of 48 prespecified items was evaluated in a subset (n=79). Results: Correlations in the expected direction were observed for 116/124 PRO-CTCAE items with the QLQ-C30 global health scale (mdn r=-.21; range .08 to -.57). Stronger correlations were seen for PRO-CTCAE items with conceptually related QLQ-C30 domains: fatigue with physical, role and social functioning (-.54 to -.66); anxiety and depression with emotional functioning (-.54 to -.70); and concentration and memory problems with cognitive functioning (-.62 to -.72) [all p