DESCRIPTION (provided by applicant): This application proposes to develop and evaluate Anxiety with Cancer in the Elderly (ACE), a cognitive-behavioral therapy-based (CBT) intervention for anxiety designed to meet the unique needs of older adults (OAs; ≥65 years) with advanced cancer and their informal caregivers (spouse/partner, adult children). This study will develop ACE (Phase I); obtain feedback on ACE from cancer patients, their caregivers, and healthcare providers (Phase II); and examine the acceptability, feasibility, and efficacy of ACE (Phase III). Significance. Anxiety is prevalent in OA cancer patients and their informal caregivers and is associated with more severe physical side-effects, poor quality of life and treatment adherence, poor communication with the healthcare team, and a weaker patient-oncologist alliance. In addition, over half of advanced cancer patients who meet diagnostic criteria for a psychiatric disorder do not receive treatment. CBT is a well-validated treatment for anxiety. However, traditional CBT has not been tailored to meet the unique needs of OAs with advanced cancer and their caregivers. Specific Aims. This study will develop and evaluate the feasibility and acceptability of a CBT-based intervention for anxiety in OAs with advanced cancer and their informal caregivers. This study will also examine the impact of the intervention on anxiety, depression, quality of life, coping, and patient-oncologist communication and alliance. Long-Term Objectives. This study will support a more extensive examination of this intervention with larger more diverse samples, leading to a widely validated and disseminable intervention tailored to OAs with advanced cancer and their caregivers. Research Plan. For Phase I, ACE, a CBT intervention for OAs with advanced cancer will be developed. In Phase II, ten patients, age 65 years or older and their primary caregiver and ten healthcare providers with experience in geriatric care will be asked to review ACE and provide feedback. In Phase III, forty OA cancer patients with advanced cancer and clinically significant anxiety and their caregivers will be randomly assigned to ACE or usual care control condition. Patients will complete assessments at baseline, during the intervention, and post intervention. Environment. Participants will be recruited from the New York Presbyterian Cancer Center, one of the largest cancer care centers in NYC with ample patient availability. The PI will receive mentorship from internationally recognized clinical researchers and leaders in aging, psychooncology, and palliative care and will leverage the rich and diverse resources from the Weill Cornell Medical College (WCMC) Center for End-of- Life Research and the Division of Geriatrics and Palliative Care. Relevance to Aging. This study will provide a non-pharmacologic treatment that will reduce anxiety and improve quality of life in OAs with advanced cancer and their caregivers and will support future research on interventions for OAs of minority groups and with other life-limiting illnesses.

PUBLIC HEALTH RELEVANCE: People over the age of 65 years comprise 13% of the U.S. population and 56% of cancer patients, percentages that are likely to increase as the population ages. Anxiety in patients with advanced cancer and their caregivers is associated with poor physical and psychological health and can interfere with treatment; yet, psychological interventions that address the unique needs of this understudied population have not been developed. The purpose of this study is to improve comprehensive cancer care by developing a CBT-based intervention for anxiety in older adults with advanced cancer and their caregivers and examining the feasibility and efficacy of the intervention to reduce patient and caregiver anxiety, promote quality of life, and enhance patient-oncologist communication and alliance in this population.