HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
Massachusetts General Hospital
Summary
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
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 reflec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy 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
Interventions
- BehavioralHARMONY
A psychoeducational intervention for patients with HCC
- OtherEnhanced usual care
A supportive care resource guide
Location
- Massachusetts General HospitalBoston, Massachusetts