Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06541990

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HARMONY

Enhanced usual care

Study Details

Brief summary:

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

Conditions

Hepatocellular Carcinoma

Study ID

NCT06541990

Start date

Oct 28, 2024

Status verified date

Aug, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: HARMONY

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

active comparator: Enhanced usual care

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

Interventions

HARMONY

A psychoeducational intervention for patients with HCC

Enhanced usual care

A supportive care resource guide

Primary outcome measure

  • Feasibility: study enrollment rate [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Kelsey Lau-Min

617-724-4000klau-min@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kelsey Lau-Min, MD, MSCE

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

Principal Investigator:

Kelsey Lau-Min, MD, MSCE

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-08-29.