Other Clinical Trial - Liver Cancer Prevention Randomized Control Trial

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05196867
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Karen Basen-Engquist, MD
Phone	713) 745-3123
Email	kbasenen@mdanderson.org
Status	Recruiting
Phase	N/A
Start date	February 11, 2022
Completion date	August 30, 2025

View Details

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