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NCT06541990NARecruiting

Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

Massachusetts General Hospital

Start Date

10/28/2024

Completion Date

9/30/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

HARMONY

OTHER

Enhanced usual care

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Conditions

Hepatocellular Carcinoma

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States