Liver Cancer Prevention Randomized Control Trial

Study Overview
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Brief Summary
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To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.

Detailed Description
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Hypothesis: A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD). Primary objective: To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment. Secondary objective: Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.

Official Title
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A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease

Conditions
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Fibrosis, Liver, Liver Diseases, Cirrhosis, Liver

Intervention / Treatment
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* Behavioral: Intervention Group
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Evidence of liver fibrosis (Liver fibrosis serum biomarker (FIB-4) index > 1.3 or Liver fibrosis grade > F2 by fibroscan) or hepatic steatosis (CAP score > 290) 2. Presence of at least 1 risk factor for cirrhosis: a. chronic HBV (HBsAg+ or taking anti-HBV therapy) b. chronic HCV (HCV RNA detectable or taking anti-HCV therapy) c. Meets metabolic criteria for metabolic dysfunction-associated fatty liver disease (MAFLD) i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), ii. presence of type II diabetes mellitus iii. presence of at least two metabolic risk abnormalities 1. Waist circumference >90/80cm in Asians or >102/88 cm in other racial groups) 2. Blood pressure >130/85 mmHG or specific drug treatment 3. Plasma triglycerides >150 mg/dl (>1.70 mmol/L) or specific drug treatment 4. Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl [5.6-6.9 mmol/L], or 2-hour post-load glucose levels 140-199 mg/dl [7.8-11.0 mmol] or HbA1c 5.7%-6.4% [39-47 mmol/mol]) d. AUDIT-C >4 for men and >3 for women AND AUDIT-10 = 8-15 3. At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week Exclusion Criteria: Pregnant or planning to become pregnant in next 12 months (by self-report) Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet Current or prior history of primary liver cancer or cancer that is metastatic to the liver AUDIT-10 score >15 Family or household member already enrolled into study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Immediate Intervention<br>participants will receive the 6 months intervention immediately | Behavioral: Intervention Group<br>* Participants in the intervention group will receive (1) weekly telephone or videoconference coaching; (2) health education print materials and tip sheets;(3) navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars, etc); (4) text messages related to behavioral skills; (5) a Fitbit activity tracker and Aria scale; (6) resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen); and (7) tools to manage portion sizes.<br>|
| Experimental: Arm 2: Delayed Intervention<br>participants will receive the intervention after the 6-month follow-up visit | Behavioral: Control Group<br>* Patients in the control arm will initially receive written education material about the risk factors for liver cancer and management options. They will be offered the intervention after they complete the 6-month assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FIB-4 score | a serum-based biomarker of fibrosis | up to 6 months |