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NCT Number: NCT06541990

Psychoeducational Intervention for Patients With Hepatocellular Carcinoma

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Kelsey Lau-Min, MD, MSCE

CONTACT

[email protected]

857-367-1486

Kelsey Lau-Min, MD, MSCE

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HARMONY

Behavioral

A psychoeducational intervention for patients with HCC

Enhanced usual care

Other

A supportive care resource guide

Primary outcomes

  1. Feasibility: study enrollment rate

    Time frame: 10 weeks

    ≥40% enrollment among consecutive eligible patients

Secondary outcomes

  1. Feasibility: intervention completion rate

    Time frame: 10 weeks

    ≥50% completion of 2/3 intervention sessions in the HARMONY arm

  2. Acceptability

    Time frame: 10 weeks

    ≥70% of patients in the HARMONY arm reporting Client Satisfaction Questionnaire-8 (CSQ-8) scores at or above the midpoint score of 20 on a scale from 8-32

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Lau-Min

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: HARMONY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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