Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Interventions: Behavioral: HARMONY; Other: Enhanced usual care

• 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: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• 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 three months
• Clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis
• Ability to complete study procedures English

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
HARMONY	HARMONY	HARMONY is a psychoeducational intervention that consists of five one-on-one coaching sessions and a structured session workbook.
Enhanced usual care	Enhanced usual care	The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.

Primary Outcome Measures

Name	Time	Method
Feasibility: retention rate	12 weeks	≥50% retention over the 12-week study
Feasibility: enrollment rate	12 weeks	≥50% enrollment among consecutive eligible patients

Secondary Outcome Measures

Name	Time	Method
Acceptability	12 weeks	≥75% of patients reporting Client Satisfaction Questionnaire-8 scores above the midpoint score of 20 on a scale from 8-32 (higher scores indicate higher satisfaction)

Trial Locations

Locations (1)

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