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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