This clinical trial tests whether a behaviorally-based tailored disease management intervention works to prevent liver cancer in patients with liver fibrosis or other risk factors for liver disease. The disease management intervention may lower the risk of liver cancer through exercise, diet, and health promoting lifestyle changes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05196867.
PRIMARY OBJECTIVE:
I. To test the effect of the behavioral intervention on fibrosis in a randomized trial.
SECONDARY OBJECTIVE:
I. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive telephone or video conference coaching once a week, health education print materials and tip sheets, navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars,etc), text messages related to behavioral skills, a Fitbit activity tracker and Aria scale, resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen), and tools to manage portion sizes over 6 months. Patients also undergo blood sample collection during screening.
ARM II: Patients are alerted in 6 months to begin the same intervention described in Arm I.
After completion of study treatment, patients are followed for up to 12 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKaren M. Basen-Engquist