Liver Cancer Prevention Randomized Control Trial

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Fibrosis, Liver; Cirrhosis, Liver; Liver Diseases

Treatments: Behavioral: Control Group; Behavioral: Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05196867

2021-1015

NCI-2021-14391 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Arm 1: Immediate Intervention

Experimental group

Description:

participants will receive the 6 months intervention immediately

Treatment:

Behavioral: Intervention Group

Arm 2: Delayed Intervention

Experimental group

Description:

participants will receive the intervention after the 6-month follow-up visit

Treatment:

Behavioral: Control Group