Joseph A. Greer, Ph.D. - US grants

[unreadable] DESCRIPTION (provided by applicant): Title: Brief CBT for Anxiety and Advanced NSCLC Project Summary/Abstract Overview: This is an application to develop and preliminarily test cognitive-behavioral therapy (CBT) for the treatment of anxiety in individuals with advanced non-small cell lung cancer (NSCLC). The overall goal is to lay the necessary groundwork for a full-scale randomized controlled trial of this treatment. Background: CBT for anxiety is an evidence-based, validated psychosocial intervention for anxiety which has not been examined in oncology patients in general or advanced lung cancer in particular. Lung cancer is the second most frequently diagnosed cancer and one of the leading causes of death in the U.S. Coping with this diagnosis can cause clinically significant, distressing, and interfering anxiety associated with impaired quality of life and worse medical outcomes. Research Plan: This study will follow NIH-defined guidelines for behavioral therapies development. Accordingly, there will be two phases. The first phase is to adapt state-of-the-art CBT for anxiety to the specific population of patients with advanced NSCLC. This will involve conducting qualitative interviews to obtain feedback from patients with advanced lung cancer on the components of CBT for anxiety, developing an outline of a treatment manual, and piloting the intervention openly. The second phase is a pilot randomized controlled trial of the psychosocial intervention following the treatment manual outline to examine patient acceptability, feasibility of delivery, and an estimation of the effect size for anxiety reduction and improvement in quality of life. Environment: The study will take place at Massachusetts General Hospital, drawing on the clinical and research expertise of the Centers for Cancer Care (the Thoracic Oncology Service) and the Department of Psychiatry's Behavioral Medicine Service which has considerable expertise in cognitive behavioral therapy development and testing. The timely opportunity for study recruitment is facilitated by ongoing research in the Thoracic Oncology Service that will be screening for psychiatric distress in individuals with lung cancer. Mentorship will be provided by Steven Safren, PhD and Holly Prigerson, PhD, nationally-recognized experts in the development and testing of CBT protocols for diverse medical populations and the assessment and epidemiology of psychological disorders among patients with advanced cancer, respectively. Relevance of Research: The study will further understanding of the impact of anxiety on advanced cancer patients. Novel interventions for alleviating distress and improving quality of life will be developed. Approximately 30% of patients with advanced lung cancer experience debilitating anxiety symptoms that are associated with worse medical and psychosocial outcomes. The purpose of the present investigation is to develop and pilot test a behavioral intervention that can be delivered to oncology patients in a timely and accessible manner. Through this study, we will gain a deeper understanding of the psychosocial needs of patients with advanced lung cancer as well as create a state-of-the-art behavioral intervention that addresses these concerns and improves patients' overall quality of life. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): With the increasing requirements for assuming prominent disease management and preventive screening activities, primary care physicians find themselves lacking cost-effective resources to improve the quality of medical care they provide to patients with chronic medical conditions. For example, the National Committee for Quality Assurance (NCQA) has begun promoting a model of comprehensive patient care referred to as Patient-Centered Medical Home (PCMH). To meet the disease management requirements for becoming a PCMH in an era of scarce resources, physicians need cost-effective tools to automate functions including contact with patients, accurate assessment of disease status, feedback to patients regarding results, and efficient documentation of those results in the health record. The purpose of the proposed SBIR award is to develop a web based asthma management module that can be integrated seamlessly into the office workflow of community primary care practices that employ either electronic health records or paper charts. We will design an online tool that will be used to contact patients via email inviting them to complete the Asthma Control Test (ACT), a brief self-report measure of asthma control, at the study website. Patients whose ACT scores reveal poor asthma control will receive more intensive care, while those with scores indicating adequate control will receive less frequent contact, thus helping practices prioritize according to patient needs. Along with the online ACT, we will co-administer validated measures to assess salient behavioral and psychological comorbities that have been associated with poor asthma outcomes, including medication adherence, smoking status, and level of psychological distress. Patients and clinicians will receive results of the online assessments along with brief interpretation of those findings. Patients will also have access to online self management tools including a daily peak flow recording module and an electronic Asthma Action Plan. In the proposed pilot study of single group design, we will use mixed qualitative and quantitative methodology by conducting focus groups with clinicians and patients as well as recruiting 50 adult patients with asthma to participate in a six-month longitudinal assessment of their use of the web-based disease management module. The aims of this pilot study are: 1) to examine the acceptability and feasibility of use of the web-base application, and 2) to establish the effect size of the intervention in improving objective measures of lung function (office spirometry), with the ultimate goal of powering a large-scale, randomized controlled trial of the product. We believe this product has strong potential for clinical and commercial success as reimbursement structures evolve to include more incentives for primary care physicians to provide quality, comprehensive, and patient-centered medical care. PUBLIC HEALTH RELEVANCE: With a growing shortage of primary care physicians, new tools are needed to help improve the quality of care for the more than 20 million Americans with asthma without adding additional time burden or costs for these doctors. Developing an efficient, low-cost, online disease management system that integrates with the established workflow and charting in primary care offices may indeed represent a sustainable new method for improving patient asthma care.

Project Summary Background: Dyspnea is a common and debilitating symptom of advanced lung cancer, with approximately 50% of patients reporting marked breathlessness. Dyspnea is associated with impaired quality of life, decreased participation in social activities, symptoms of depression and anxiety, and even desire for death in patients with lung cancer. Unfortunately, limited data support efficacious treatments for dyspnea. Our multidisciplinary team recently conducted a pilot study examining the delivery of a brief, two-session behavioral intervention for dyspnea management in patients with advanced lung cancer. Trained nurse practitioners administered the intervention to patients in the infusion clinic to facilitate greater access and participation. We observed statistically and clinically significant effects on patient-reported breathlessness, quality of life, and depression symptoms, as well as high patient satisfaction with the intervention components and delivery. Study Aims: For the proposed project, we seek to build on our prior positive findings by conducting a randomized controlled trial (RCT) of the intervention in a larger sample of patients with advanced lung cancers. We will first train oncology nurses to deliver the brief behavioral intervention for dyspnea management, again at the point of care within the infusion clinic as this approach was central to the feasibility and acceptability of the intervention in our pilot study. The specific aims of this study are to demonstrate the efficacy of the brief behavioral intervention for improving self-reported dyspnea (primary outcome) as well as quality of life, mood, and activity level (secondary outcomes) in patients with advanced lung cancer. Study Design & Methods: We will enroll and randomly assign up to 200 patients diagnosed with advanced lung cancer (100 per study group) to receive either the brief behavioral intervention for dyspnea or usual care. The trial will take place at the Massachusetts General Hospital Cancer Center and the Dana-Farber Cancer Institute. Oncology nurses will deliver two, 45 minute interventions sessions for each participant within the infusion clinic. All participants will complete measures of dyspnea, quality of life, anxiety and depression symptoms, as well as activity level at baseline after completion of the intervention phase at 8, 16, and 24 weeks. Conclusions: Other than opioid medications, which offer little clinical benefit, data are lacking to support the efficacy of treatments for dyspnea, a highly impairing symptom in patients with advanced lung cancer. We plan to train oncology nurses in delivering a dyspnea management intervention that incorporates behavioral techniques shown to be effective for improving breathlessness and reducing stress in patients with cancer. By training medical clinicians to administer the behavioral intervention in the oncology care setting, we hope to maximize broad dissemination and patient access to essential symptom management. Data from this R01 will ultimately serve as the basis to apply for funding for a large-scale, multisite effectiveness and dissemination study of the intervention.