Liver Cancer Prevention Randomized Control Trial

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    266
  • sponsor
    M.D. Anderson Cancer Center
Updated on 22 March 2022
cancer
liver disease
hbsag
fibrosis
fibroscan

Summary

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

Description

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.

Details
Condition Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver
Treatment Control group, Intervention group
Clinical Study IdentifierNCT05196867
SponsorM.D. Anderson Cancer Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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])
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
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