Psychoeducational support for patients with liver cancer
HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
NA · Massachusetts General Hospital · NCT06541990
This study is testing a new support program for people recently diagnosed with liver cancer to see if it helps them feel better compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06541990 on ClinicalTrials.gov |
What this trial studies
This study aims to refine and pilot test HARMONY, a psychoeducational intervention designed for patients recently diagnosed with hepatocellular carcinoma (HCC). The study consists of two parts: the first part is an open pilot study to gather data for refining the intervention, while the second part is a pilot randomized controlled trial (RCT) that assesses the feasibility and acceptability of HARMONY compared to enhanced usual care. Participants will complete a baseline survey before being randomized to either the HARMONY intervention or a supportive care resource guide.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have received a new diagnosis of HCC within the last three months and have concomitant cirrhosis.
Not a fit: Patients with significant uncontrolled hepatic encephalopathy, cognitive impairment, or those nearing the end of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the psychological well-being and coping strategies of patients diagnosed with hepatocellular carcinoma.
How similar studies have performed: While psychoeducational interventions have been explored in various cancer settings, this specific approach for HCC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Kelsey Lau-Min
- Email: klau-min@mgh.harvard.edu
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma