NCT06541990

Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).

Detailed description

There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2. Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	HARMONY	A psychoeducational intervention for patients with HCC
OTHER	Enhanced usual care	A supportive care resource guide

Timeline

• Start date: 2024-10-28
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2024-08-07
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States