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NCT05196867 | RECRUITING | Liver Diseases

Liver Cancer Prevention Randomized Control Trial
Sponsor:

M.D. Anderson Cancer Center

Brief Summary:

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

Condition or disease

Liver Diseases

Fibrosis, Liver

Cirrhosis, Liver

Intervention/treatment

Intervention Group

Control Group

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 266 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
Actual Study Start Date : 2022-02-11
Estimated Primary Completion Date : 2025-08-30
Estimated Study Completion Date : 2025-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography \[F2 score ≥ 8kPa\]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR
    • 1. Waist circumference ≥90/80 cm 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 or specific drug treatment
    • 4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
    • 5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
    • AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following
      • 1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or
      • 2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy)
      • 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:
      • 1. Pregnant or planning to become pregnant in next 12 months (by self-report)
      • 2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
      • 3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
      • 4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver
      • 5. AUDIT-10 score \>15
      • 6. Family or household member already enrolled into study
Liver Cancer Prevention Randomized Control Trial

Location Details

NCT05196867

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Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030