This revised competing renewal application seeks to extend our previous work among patients with end stage lung disease to evaluate the effectiveness of a novel, enhanced coping skills training (CST) protocol for patients with chronic obstructive pulmonary disease (COPD). COPD is an obstructive airway disease marked by symptoms of dyspnea, paroxysmal coughing, pain, fatigue, and insomnia. Approximately 12.1 million Americans have been diagnosed with COPD and 70 percent of these cases represent individuals under the age of 65. COPD patients who are at an early stage of their disease often experience a progressive worsening of symptoms, while the advanced stages of the disease may be marked by frequent visits to the emergency department or inpatient hospitalizations for acute COPD exacerbations. Importantly, COPD also is a fatal condition for many patients, and is the fourth leading cause of preventable death for both men and women in the United States, with over 120,000 deaths reported in 2002. Although COPD is preventable (i.e., by not smoking), there is no cure for the disease and therefore the symptoms must be managed effectively. It has been well-established that brief, focused cognitive-behavioral therapy can significantly improve psychological function in medically ill persons, the wide geographic distribution of patients with COPD, along with their chronic exacerbations of illness, make face-to-face delivery of such therapy extremely difficult. Our previous work demonstrated that a telephone-based coping skills intervention (CST) with patients awaiting lung transplantation was effective in improving quality of life but did not improve physical functioning or survival. In that study, patients with COPD at an earlier stage of their disease process appeared to benefit most from CST. Thus, the present application proposes a larger, dual-site (Duke and Ohio State University), randomized trial among patients with COPD, using a comprehensive set of outcome measures over an extended follow-up period. Six hundred COPD patients will be randomly assigned to either a telephone-based enhanced, caregiver-assisted CST intervention or to a Usual care plus education and symptom monitoring Control group. Patients and their self-identified caregivers will undergo comprehensive assessments of physical and psychosocial functioning before and after a 16-week intervention. The study will examine the short- and longer- term impact of CST on psychological distress and quality of life as well as the effects of the intervention on morbidity, mortality, and medical costs over a follow-up period of up to 4 years. The ultimate goal of this research program is to develop more effective ways to help patients with chronic lung disease and their caregivers cope more effectively with problematic symptoms, reduce distress, improve quality of life, enhance physical functioning, and increase survival. Public Health Relevance: Chronic Obstructive Pulmonary Disease (COPD) is a significant health problem in the United States and throughout the world, and is considered the fourth leading cause of death in the US. This study will examine the effects of an enhanced coping skills training program for COPD patients and their caregivers, delivered by telephone, on patients'psychosocial and physical functioning and long-term survival.
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