Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
HARMONY
HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Oct 2024
Shorter than P25 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
August 29, 2025
August 1, 2025
1.7 years
August 3, 2024
August 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility: study enrollment rate
≥40% enrollment among consecutive eligible patients
10 weeks
Secondary Outcomes (2)
Feasibility: intervention completion rate
10 weeks
Acceptability
10 weeks
Study Arms (2)
HARMONY
EXPERIMENTALHARMONY is a psychoeducational intervention that consists of three one-on-one coaching sessions and a structured session workbook.
Enhanced usual care
ACTIVE COMPARATORThe enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- New diagnosis of HCC within the last six months
- Ability to complete study procedures English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2024
First Posted
August 7, 2024
Study Start
October 28, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share