Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06541990
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-03
• Study First Posted: 2024-08-07
• Study Start: 2024-10-28
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-24
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥18 years
• New diagnosis of HCC within the last six months
• Ability to complete study procedures English

Exclusion Criteria

• Incidentally diagnosed with HCC after liver transplantation
• Significant uncontrolled hepatic encephalopathy, cognitive impairment, or psychiatric disorder which will interfere with study participation
• Patients near the end of life for whom hospice is recommended

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: study enrollment rate	10 weeks	≥40% enrollment among consecutive eligible patients

Secondary Outcome Measures

Name	Time	Method
Feasibility: intervention completion rate	10 weeks	≥50% completion of 2/3 intervention sessions in the HARMONY arm
Acceptability	10 weeks	≥70% of patients in the HARMONY arm reporting Client Satisfaction Questionnaire-8 (CSQ-8) scores at or above the midpoint score of 20 on a scale from 8-32

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States