Psychoeducational Intervention for Patients With Hepatocellular Carcinoma (HARMONY)

Mass General Brigham

Status: Enrolling

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Behavioral: HARMONY; Other: Enhanced usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06541990

24-371

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

HARMONY

Experimental group

Description:

HARMONY is a psychoeducational intervention that consists of five one-on-one coaching sessions and a structured session workbook.

Treatment:

Behavioral: HARMONY

Enhanced usual care

Active Comparator group

Description:

The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.

Treatment:

Other: Enhanced usual care