| Program Leader: J. Von Roenn, MD |
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Program Co-Leader: TBD |
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The Cancer Control Program of the Robert H. Lurie Comprehensive Cancer Center is focused on three thematic areas: costs and patterns of oncology-related treatment; measuring, analyzing, and interpreting quality of life; and palliative and rehabilitation oncology. The Program leader is David Cella, PhD, a distinguished psychologist who is an internationally recognized leader in outcomes measurement, and co-leader Charles Bennett, MD, PhD, MPP, clinical oncologist and highly regarded investigator in health services research. The research programs and expertise of these two leaders are complementary, which allows for the development and enhancement of successful research programs in each of the three thematic areas. Moreover, the Cancer Control program has grown considerably over the past five years, with subsequent expansion of the existing outcomes research program. The Cancer Control Program is comprised of 26 members from 13 departments and 2 schools. Between January, 2001 and September, 2006 there have been 389 cancer-relevant publications from the current program members. Eighty (20.6%) of these publications represent intra-programmatic collaborations and 86 (22.1%) represent inter-programmatic collaborations. Total current cancer-relevant peer-reviewed funding is $5,399,241 (direct) with $2,195,107 (direct) from NCI, and $3,204,134 (direct) from other peer-reviewed sources. Specific areas of research include: basic measurement science; behavioral science; supportive care; palliative medicine; clinical trial design, statistical analysis and interpretation of clinical trial data; cost-effectiveness analysis; patterns of care research; pharmacovigilance; and health policy. There are significant interactions with the programs in Cancer Prevention, Breast Cancer, Prostate Cancer, Hematologic Malignancies, Tumor Invasion, Metastasis and Angiogenesis, and Cancer Genes and Molecular Targeting. The Cancer Control Program of the RHLCCC has established itself as a national and international leader in research focusing on pharmacovigilance, outcomes measurement, and end-of-life care.
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The major research focus of this thematic area is to improve cancer-related care, and research studies address costs, quality, access, and public policy considerations. The group has an extensive focus on pharmacovigilance of new cancer therapeutics and supportive care agents, clinical trial participation, and improving access. Under the direction of Dr. Bennett, the Research on Adverse Drug Events and Reports (RADAR) project team includes formal collaborations with the University of Utah School of Medicine, the Oregon Health Sciences Center, the University of New Mexico, and the Department of Veterans Affairs. Dr. Wolf is a leading investigator in the area of communication of pharmaceutical safety messages to low literate individuals. The Northwestern University Feinberg School of Medicine has dedicated seed funds to support Dr. Wolf's effort to create a center that specializes in health communication for persons with poor health literacy skills. Dr. McKoy is a recipient of an NCI minority supplement (linked to the RHLCCC core grant) with a specific focus in geriatric oncology. With this core support, she studies health care fraud in the provision of prostate cancer pharmaceuticals and pharmacovigilance related to leukemia treatment. With support from the RHLCCC, Dr. Lacouture has created a novel clinic (the SERIES clinic) that rapidly evaluates dermatologic toxicities of novel cancer agents with a focus on the anti-VEGF, tyrosine kinase inhibitors, and EGFR inhibitors. Dissemination of information through meta-analyses is also a focus with the most recent effort (led by Dr. Bennett) on erythropoietin and granulocyte colony stimulating factor therapies. This work is targeted to be policy relevant and is being disseminated through the Cochrane Collaboration, the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).
Other research areas address the patterns and quality of cancer-related care for racial/ethnic minorities and the medically underserved, with the majority representing work that is funded by peer-reviewed granting agencies, and the remainder funded either by medical societies or philanthropic funds. Drs. Bennett and Chang conduct research on improving decision making for low literacy individuals with prostate cancer. In collaboration with decision scientists and clinicians, they are leading efforts to improve both the patient's and the physician's efforts (VA and American Cancer Society funded). Other grant supported studies include a U01 grant from the NCI to improve navigation through the health care system among racial/ethnic minorities with positive screening tests for cancers of the colon/rectum, prostate, cervix, and breast. This study represents a formal collaboration with the RHLCCC, the University of Illinois-Chicago School of Public Health, the Jesse Brown VA, and the Access Healthcare System (the largest federally-qualified health center in the country). Importantly, philanthropic funds support three college student interns to the Chicago Navigator Project annually (the Pattis Family Foundation). The Chicago Cancer Navigation Project is evaluating clinical and immunologic findings for racial/ethnic minority women who are at high risk for development of cervical cancer.
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The research focus of this thematic area is to understand and place in appropriate context the QOL of people affected by cancer, from diagnosis and treatment through survivorship. This includes identifying salient physical and psychosocial issues associated with all points on the trajectory of the illness of cancer, including initial diagnosis and treatment, disease-free survival, coping with recurrent disease and death and dying. Additional research includes measurement and improving measurement models to create more precise, practical and interpretable QOL and treatment outcome data. Other research activities are also in the area of clinical trial design, including analysis and interpretation of QOL data collected in national and international clinical trials. The members of this thematic group spend the majority of their time focusing on cancer, and this focus is rewarded by the RHLCCC provision of fellow and junior faculty small grant awards to stimulate pilot activity directed toward cancer. Specific examples are Drs. Yost, Lai, and Yount, each of whom has received direct or indirect RHLCCC support for pilot research over the past 5 years. While they could focus their efforts in any number of areas, these formally trained social and measurement scientists have opted to place their primary research emphasis on cancer. This is because the RHLCCC has proactively provided incentives to these scientists to apply for cancer-targeted research questions that require their unique expertise. Drs. Chang and Lai, trained in educational measurement techniques, have brought new perspective and methods to the health status measurement field. Working with Dr. Cella, they are among the pioneers introducing item response theory techniques and applications to health-care measurement. Dr. Cella's R01 award (CA60068) was the first NCI award to bring item response modeling to oncology application. As mentioned, this has now grown into a subsequent competing continuation R01 and the Roadmap PROMIS Coordinating Center responsibility. The NIH Roadmap initiative was designed to provide a framework for optimizing NIH-funded research across the NIH institutes. One of its objectives was to establish a more efficient infrastructure for conducting clinical research. Toward this goal, the NIH funded an initiative in dynamic assessment of patient-reported chronic disease outcomes known as the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS aims to build and validate a set of item banks to measure key symptoms and health concepts generalizable to a range of chronic health conditions, which will enable efficient and interpretable clinical trial research and clinical practice application of patient-reported outcomes. Dr. Cella directs the Statistical Coordinating Center for PROMIS and is also directing a funded expansion into cancer to enhance the cancer-relevance of existing banks and to identify potential new cancer-relevant bank domains. Drs. Lai, Yount, Wagner, and Yost, and Ms. Hahn, are RHLCCC member collaborators.
Dr. Cella also directs a national, multiple-industry-sponsored project with the National Comprehensive Cancer Network (NCCN) and local community organizations investigating patient-based priorities for symptoms and concerns to be monitored while treating advanced cancer. Ms. Hahn, a medical sociologist and biostatistician who came from the cardiovascular clinical trials area, has become a valued independent investigator for the RHLCCC, and has embarked on R01 research funded by AHRQ, NCI, and NHLBI to develop and test multimedia computer-based programs to facilitate QOL and health literacy assessment of English- and Spanish-speaking patients with low literacy skills. In an American Cancer Society-funded project, Drs. Cella and Bennett collaborated to assess QOL among low literacy individuals with prostate cancer. This work continues with national funding from the Health Services Research and Development program of the Department of Veterans Affairs and the American Cancer Society supporting a study of QOL and patterns of care for prostate cancer patients who experience PSA failure and who receive care at the VA Medical Centers, the University of Illinois, and the Cook County Medical Center. By formally bringing together and providing shared resource and small grant incentives to Dr. Cella's and Bennett's groups, the RHLCCC promotes these intra-programmatic interactions. These examples illustrate the many opportunities for cancer focus among the multidisciplinary group of investigators in this thematic area.
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The three major areas of research focus for this group are: symptom control for patients with cancer, acute and long-term rehabilitation issues for cancer patients, and design and implementation of educational programs for health-care providers in the area of palliative care. The work on symptom control in cancer has included efforts by Dr. Von Roenn to evaluate the impact of various interventions on cancer-related weight loss (Bristol-Myers Squibb Oncology funded) and by Dr. Paice to investigate the prevalence and characteristics of chemotherapy-induced peripheral neuropathy (along with Drs. Von Roenn and Apkarian). In addition, Drs. Von Roenn, Paice, Cella, and Wagner continue to refine and evaluate an outpatient Supportive Oncology (symptom management) clinic (Coleman Foundation funded). Drs. Apkarian, Paice, Mantyh, and Von Roenn are working to develop a comprehensive translational research program of chemotherapy-induced peripheral neuropathy (CIPN) that includes correlating findings from rodent models of CIPN with the human experience using quantitative sensory testing, skin-punch biopsies to evaluate anatomic changes, and fMRI/MR to evaluate neuroanatomic changes. Aspects of these studies were included in the application for the Breast SPORE; proposals have also been submitted to the American Cancer Society and the Oncology Nursing Society. Additionally, an R01 is planned for Winter, 2007. In the area of rehabilitation oncology, Drs. Mittal and Logemann have been working on speech and swallowing dysfunction in head and neck cancer. Dr. Logemann has significant support (NCI funded) for work on site- and treatment-specific long-term sequelae and quality of life for patients with head and neck malignancies. She not only obtained support (NCI) for evaluation of long-term survivors of head and neck cancer, but she also developed the Performance Status Scale for Head and Neck Cancer (PSS-HNC). Dr. McVary has support (NIDDK funded) for his research on the neural underpinnings of sexual dysfunction after neural injury in the setting of prostate cancer after prostatectomy. Dr. Jim Sliwa is involved in the development of a comprehensive rehabilitation program for patients with cancer by developing a link between the RHLCC and the Rehabilitation Institute of Chicago (RIC). In the area of educational research in palliative oncology, Dr. Von Roenn developed some of the original curricula for medical students, residents and oncology fellows in the area of symptom control and palliative care. In conjunction with these efforts, a cancer pain education program was developed with NCI funding (R25 CA57818-04A1) which has been a model nationally. In addition, Dr. Emanuel coordinated the development of a national curriculum for the training of physicians in palliative care (Robert Wood Johnson funded) as well as a train-the-trainer program and educational outcomes assessment (Robert Wood Johnson funded). Furthermore, Drs. Von Roenn and Emanuel developed an oncology version of this train-the-trainer program, called EPEC-Oncology.
In other noteworthy activity under this thematic area, Dr. Yount, a clinical psychologist, is the Principal Investigator of a randomized clinical trial (R01 CA115361: "Weekly Symptom Telemanagement in Advanced Lung Cancer"), to evaluate the efficacy of a computer-assisted telephone survey system to monitor lung cancer patients' symptoms and generate a summary report in "real-time" for use by physicians in the clinical management of their patients. People with advanced lung cancer often experience multiple debilitating symptoms, many of which emerge when patients are home between clinic appointments. Unrecognized symptoms can result in reduced health-related quality of life (HRQL), decreased treatment efficacy, and emergency room visits and hospitalizations. Significant barriers to adequate symptom management include patient reluctance to communicate about symptoms with their physicians, lack of routine systematic symptom assessment by clinicians, and clinic time and resource constraints. To address these barriers, this trial will test a Symptom Monitoring and reporting system for advanced Lung cancer (SyMon-L). Symon-L employs a combination of computer and interactive voice response (IVR) technologies to allow routine, systematic symptom assessment of patients at home between office visits with minimal burden on staff and patients. Patients in the "monitoring & reporting" (MR) arm telephone the system on a weekly basis for 12 weeks to complete a brief symptom measure. A nurse monitors weekly symptom scores and contacts the patient and physician for consultation when scores reach a pre-defined threshold warranting clinical attention. SyMon-L generates longitudinal graphic displays of patients' symptom experience for review during clinic visits. Patients in the "monitoring alone" (MA) arm complete the weekly symptom surveys by phone but their scores are not reported to the clinical team. The proposed RCT seeks to demonstrate that this system identifies clinically significant problems before they are detected in routine clinical care and results in enhanced clinical management of symptoms. The primary outcome is symptom burden over 12 weeks; secondary endpoints include patient HRQL, treatment satisfaction, self-efficacy, patient-perceived barriers to symptom management, and patient and provider satisfaction with SyMon-L.
In a similar study using the same technology, but expanding the scope beyond lung cancer and adding computerized adaptive testing (CAT), Dr. Cella is conducting a second symptom management trial. This trial is funded under a continuously running R-01 in place since 1995 (i.e., through two competing renewals, R-01 CA 60068-09-13). The advent of computerized adaptive testing (CAT) using item response theory (IRT) provided a unique opportunity to integrate health-related quality of life (HRQL) and symptom management research into individual clinical practice. In our current project, we have been developing brief-yet-accurate and user-friendly assessments of symptoms and function in individual cancer patients since 1995. Now we will refine and broaden our current item banking program in fatigue (F), physical function (PF), pain (P), emotional distress (ED), illness impact (II), perceived cognitive function (PCF), social support (SS), and social role participation (SRP) to reflect the current HRQL model (Aim 1); and test the efficacy of routine and targeted symptom monitoring (SyMon) and management for advanced cancer patients (Aim 2). In this project we are refining and administering items to sufficient numbers of patients (n=2000) from clinics and via nation-wide internet testing to evaluate measurement equivalence across gender, race, and, where possible, disease type. We will then be able to fully explore the dimensionality of the items and the usefulness of 1-PL and 2-PL IRT models. We will create CAT applications, incorporating patient- and clinician-derived estimates of clinically meaningful changes in scores to be used in Aim 2. For Aim 2, we propose a 4-month efficacy study with a modified crossover design (n=140) to evaluate whether routine and targeted CAT-derived assessments of F, PF, P, and ED paired with management recommendations can improve symptom burden, patient satisfaction, communication, and HRQL outcomes among advanced cancer patients receiving chemotherapy. The intervention will consist of providing CAT-derived scores to patients, and scores with specific guideline-driven recommendations to clinicians. We will also monitor treatment/management changes, and evaluate acceptability of computer assessments and the perceived benefits of the recommendations. These projects exemplify a major new emphasis in our palliative care research program. Capitalizing on our leading edge technology for real-time data capture and presentation of clinical information to patient and provider, we aim to test and disseminate effective tools for cancer symptom management in clinical practice. These projects are highly collaborative with clinical colleagues on both the downtown and Evanston campuses and include Drs. Paice, Wagner, VonRoenn, Shevrin, Hensing, and Patel among others.
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