PROJECT SUMMARY These is a growing population of lung cancer survivors (LCS) in the United States, estimated at nearly 655,000, many of whom experience disproportionate symptom burden compared to other cancer survivors. Among LCS, bothersome symptoms such as insomnia, fatigue, pain, anxiety, depression, and respiratory issues (e.g., dyspnea, cough) frequently co-occur. Insomnia is a top patient-rated concern and a leading risk factor for impaired quality of life endorsed by 50-80% of LCS. Cognitive Behavioral Therapy for Insomnia (CBT-I), the gold standard insomnia treatment, is safe and highly effective for cancer survivors in a variety of formats, and it has a high potential to improve insomnia and co-occurring symptoms among LCS. Despite the promise of CBT-I, it has not been adequately tested for LCS, a high need population that is often difficult to reach with supportive care interventions due to numerous barriers (e.g., diminished physical health, respiratory comorbidities, stigma). Attention to the unique needs of LCS through stakeholder engagement to refine CBT-I content and delivery will enhance its potential impact and facilitate implementation of CBT-I across care settings and clinically complex populations. Through multidisciplinary stakeholder engagement, the goal of this NCI Early K99/R00 is to refine (Aim 1) and test (Aims 2 & 3) CBT-I delivery and components for insomnia and related symptoms in LCS. The K99 phase of this project aims to: 1) conduct stakeholder interviews (N=20 LCS, N=10 clinicians) and convene an Intervention Development Advisory Board to refine CBT-I for the specific needs of LCS to enhance its feasibility and acceptability. The R00 phase aims to: 2) conduct a 2-arm pilot feasibility trial with N=30 LCS to determine the feasibility and acceptability of refined CBT-I for LCS with insomnia; and 3) measure key patient-reported outcomes (e.g., insomnia, fatigue, pain, anxiety, depression, dyspnea, cough) and objective measures (e.g., circadian and sleep health, pulmonary function) for a future randomized efficacy trial. To complete these research aims, the candidate (Dr. Sarah Price) requires mentored didactic and experiential training in 4 key areas: 1) psychosocial intervention development and optimization; 2) community and stakeholder engagement; 3) subjective and objective assessment of cancer-related symptoms; and 4) professional development. Dr. Price will receive training in these areas from her excellent mentoring team with the requisite expertise (Drs. Kathryn Weaver, W. Jeffrey Petty, Oxana Palesh, and Emily Dressler). This K99/R00 award will provide Dr. Price with essential training and pilot data to support a subsequent R01 grant proposal to conduct a large-scale multiphase optimization strategy (MOST) trial to identify an optimized treatment package to address insomnia and related symptoms. She will be well-equipped to reach her long- term goal to become an independent cancer control investigator with expertise in developing efficient symptom management interventions.

PROJECT NARRATIVE Despite its promise for treating insomnia and co-occurring symptoms, Cognitive Behavioral Therapy for Insomnia (CBT-I) has not been adequately tested for lung cancer survivors (LCS), a high need population that is often difficult to reach with supportive care interventions due to numerous barriers (e.g., diminished physical health, respiratory comorbidities, stigma). Attention to the unique needs of LCS through stakeholder engagement to refine CBT-I content and delivery will enhance its potential impact and facilitate implementation of CBT-I across care settings and clinically complex populations. Through multidisciplinary stakeholder engagement, the goal of this NCI Early K99/R00 is to refine CBT-I delivery and components for insomnia and related symptoms in LCS (Aim 1) and test the feasibility and acceptability (Aim 2) and future efficacy outcomes (Aim 3) of the refined intervention.