Development and refinement of a behavioral coaching intervention for patients with hepatocellular carcinoma.

331 Background: Hepatocellular carcinoma (HCC) is a common cause of cancer and cancer-related mortality and is attributable to liver cirrhosis in ~80% of cases. Patients with HCC struggle with high levels of psychological distress and quality of life (QOL) impairments due to difficulty managing cancer- and liver disease-related symptoms, uncertainty stemming from gradual tumor progression and unpredictable episodes of liver decompensation, and stigma related to liver disease’s association with substance use and sexually transmitted infections. We aimed to develop and refine a novel supportive care intervention to reduce psychological distress and improve QOL in this population. Methods: We integrated stakeholder input from 4 patients, 1 caregiver, and 7 clinicians in oncology, hepatology, and behavioral medicine with principles of chronic disease self-management, cognitive behavioral therapy, and positive psychology to develop “HARMONY.” We conducted an open pilot study of adult patients diagnosed with any stage of HCC in the last 6 months who had concomitant cirrhosis. All participants received HARMONY and were asked to rate each session on a 1-10 scale (higher scores indicated higher acceptability) and the overall intervention using the Client Satisfaction Scale-8 (CSQ-8, scores ≥20 on an 8-32 scale defined as acceptable). At study completion or withdrawal, patients were invited to participate in exit interviews to provide feedback on HARMONY, which we used to refine the intervention. Results: Our stakeholder- and theory-informed approach led to the development of a 5-session virtual coaching program focused on 1) disease education to enhance self-efficacy for managing concomitant serious illnesses, 2) psychosocial skills to reduce prognostic distress, and 3) self-compassion to reduce internalized stigma. We enrolled 10 participants (median age 70 years, 7 men, 6 non-Hispanic White), of whom 6 completed ≥3 and 4 completed all 5 sessions. Reasons for withdrawal included scheduling conflicts (n = 3) and lack of interest (n = 1); 2 participants were lost to follow-up due to hepatic decompensation. All 4 participants who completed HARMONY reported mean acceptability scores > 9 for each session and CSQ-8 scores ≥20 for the overall intervention. In qualitative interviews (n = 5), participants reported feeling well supported by the study clinician and enjoying the psychosocial skill-building exercises, but the disease education content was less relevant to those with low physical symptom burden. Conclusions: HARMONY is a novel intervention tailored to the unique needs of patients with HCC. We have since condensed HARMONY into 3 sessions to enhance engagement and modified the intervention structure to more flexibly address participants’ most salient needs. A pilot randomized controlled trial is planned to assess the feasibility and acceptability of HARMONY in a larger cohort of patients.