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Behavioral Intervention
Psychoeducational Therapy for Liver Cancer (HARMONY Trial)
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Age ≥18 years
* Clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new therapy called HARMONY for patients who have been recently diagnosed with liver cancer.
Who is the study for?
This trial is for adults over 18 who have been newly diagnosed with hepatocellular carcinoma (HCC), a type of liver cancer, within the last three months. They must also have cirrhosis (liver damage) and be able to complete study procedures in English.
What is being tested?
The trial is testing HARMONY, a new psychoeducational program designed to support patients with HCC. It will be compared against enhanced usual care to see if it offers additional benefits.
What are the potential side effects?
Since this is a psychoeducational intervention rather than a drug treatment, there may not be physical side effects like those associated with medication. However, participants might experience emotional or psychological responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with cirrhosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility: enrollment rate
Feasibility: retention rate
Secondary study objectives
Acceptability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HARMONYExperimental Treatment1 Intervention
HARMONY is a psychoeducational intervention that consists of five one-on-one coaching sessions and a structured session workbook.
Group II: Enhanced usual careActive Control1 Intervention
The enhanced usual care condition consists of a curated list of supportive care services for patients with HCC.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,020 Previous Clinical Trials
13,316,465 Total Patients Enrolled
10 Trials studying Liver Cirrhosis
720 Patients Enrolled for Liver Cirrhosis
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