Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
Study NCT ID:
NCT05196867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Cancer Prevention Randomized Control Trial
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-14391 | OTHER | CTRP (Clinical Trial Reporting Program) | View |