Liver Cancer Prevention Randomized Control Trial

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Fibrosis, Liver; Cirrhosis, Liver
• Intervention / Treatment: Behavioral: Intervention Group; Behavioral: Control Group

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
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Basen-Engquist, MD; Phone Number: 713) 745-3123; Email: kbasenen@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Karen Basen-Engquist, MD; Phone Number: 713-745-3123; Email: kbasenen@mdanderson.org
      • Principal Investigator: Karen Basen-Engquist, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Immediate Intervention; participants will receive the 6 months intervention immediately	Behavioral: Intervention Group; 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.
Experimental: Arm 2: Delayed Intervention; participants will receive the intervention after the 6-month follow-up visit	Behavioral: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Karen Basen-Engquist, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 2021-1015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No