PROJECT SUMMARY Accurate prognostic understanding is a critical predictor of patients' engagement in advance care planning (ACP) and receipt of less futile, aggressive care at the end of life. However, approximately half of advanced cancer patients do not understand the terminal nature of their illness. Caregivers play an integral role in patients' care and decision-making at the end of life, yet few interventions include them. Drs. Shen and Trevino's pilot work, in collaboration with their Co-Investigators Drs. Prigerson and Maciejewski, suggests that improving both patient and caregiver prognostic understanding surrounding the patient's terminal status and estimated life expectancy is associated with higher rates of engagement in ACP. Based on this pilot work and the important role of caregivers in end-of life (EOL) cancer care, this study aims to develop a communication- based intervention to improve advanced cancer patients' and caregivers' prognostic understanding. The goals of this study are to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes). To meet these goals, we will collect feedback from advanced cancer patients and their caregivers (n=10 dyads) and psychosocial experts (n=10) to improve and refine the intervention. Next, we will pilot test the intervention with n=30 patient-caregiver dyads and assess outcomes at baseline, post-intervention, and three months later to determine the feasibility, acceptability, and preliminary efficacy of the intervention on improving engagement in ACP and communication, reducing distress and caregiver burden, improving rates of goal-concordant care, and reducing rates of futile aggressive care. These results will inform a future NIH R01 application to conduct a large-scale randomized clinical trial (RCT) of intervention efficacy. Grounded in established theories of inhibitory learning and social-cognitive processing, the present study takes the novel approach of integrating communication and distress management techniques to improve patients' and caregivers' ability to discuss difficult EOL topics while managing the distress associated with these topics. It is expected that these results will form a strong foundation for a program of research focused on integrating caregivers into interventions targeting advanced cancer patients as a novel and innovative way to improve engagement in ACP, increase rates of goal- concordant care, and reduce receipt of futile, aggressive EOL care.

PROJECT NARRATIVE The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the College of Surgeons Commission on Cancer and Centers for Medicare and Medicaid Services (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. The proposed study will address this public health issue by developing a communication-based intervention designed to improve advanced cancer patients' and caregivers' prognostic understanding, reduce distress and caregiver burden, and ultimately improve engagement in ACP and receipt of goal-concordant care and reduce receipt of futile aggressive care at the end-of-life. Therefore, this study is aligned with the NCI's long-term goals of improving quality of care at the end of life and the CMS's goal of improving engagement in ACP.