This clinical trial develops and tests a new coaching program that aims to provide education and support for reducing psychological distress (depressive and anxiety symptoms) and improving quality of life (QOL) for patients with newly diagnosed liver (hepatocellular) cancer. Despite different treatment approaches, patients diagnosed with all stages of hepatocellular cancer (HCC) face substantial challenges as they navigate the complex interplay between two associated life-altering illnesses – cancer and cirrhosis (severe scarring of the liver). HARMONY is a psychoeducational intervention which focuses on disease education to enhance self-efficacy for managing comorbid (presence of two or more diseases or conditions at the same time) serious illnesses, psychosocial skills to reduce prognostic distress, and self-compassion to reduce internalized stigma. Using the HARMONY intervention may help reduce psychological distress and improve QOL for patients with newly diagnosed liver cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06541990.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Kelsey See Wai Lau-Min
Danvers
Mass General/North Shore Cancer CenterStatus: Approved
Contact: Kelsey See Wai Lau-Min
Newton
Newton-Wellesley HospitalStatus: Approved
Contact: Kelsey See Wai Lau-Min
PRIMARY OBJECTIVES:
I. To refine HARMONY for patients with newly diagnosed HCC.
II. To assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care among patients with newly diagnosed HCC.
OUTLINE:
PART 1: Patients complete surveys and participate in interviews to provide feedback to modify and refine the HARMONY program on study.
PART 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in the HARMONY program virtually consisting of three coaching sessions weekly over 1 hour with an optional fourth booster session at week 4. Sessions consist of maintaining health, strengthening support system, and coping with uncertainty. Patients also receive a structured session workbook on study.
ARM II: Patients receive a curated list of supportive care services on study.
After completion of study intervention, patients are followed up to 24 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorKelsey See Wai Lau-Min