Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
Purpose
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
Conditions
- Hepatocellular Carcinoma
- Cirrhosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years - New diagnosis of HCC within the last three months - Clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis - Ability to complete study procedures English
Exclusion Criteria
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental HARMONY |
HARMONY is a psychoeducational intervention that consists of five 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. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed 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 reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.