Hepatocellular Carcinoma
Conditions
Brief summary
This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).
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.
Interventions
BEHAVIORALHARMONY
A psychoeducational intervention for patients with HCC
OTHEREnhanced usual care
A supportive care resource guide
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: study enrollment rate | 10 weeks | ≥40% enrollment among consecutive eligible patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: intervention completion rate | 10 weeks | ≥50% completion of 2/3 intervention sessions in the HARMONY arm |
| Acceptability | 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 |
Countries
United States
Contacts
Primary ContactKelsey Lau-Min
Outcome results
None listed