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. ? ? ?
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