RecruitingInterventional

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

NCT ID: NCT06541990Sponsor: Massachusetts General HospitalLast updated: 2025-08-29

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.

Arms & interventions

BehavioralHARMONY
A psychoeducational intervention for patients with HCC
OtherEnhanced usual care
A supportive care resource guide

Outcome measures

Primary

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

Secondary

Feasibility: intervention completion rate
Time frame: 10 weeks
Acceptability
Time frame: 10 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Kelsey Lau-Min, MD, MSCE · Contact

857-367-1486 klau-min@mgh.harvard.edu

Kelsey Lau-Min, MD, MSCE · Principal Investigator