Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-14391 | Other Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Prevention Research Institute of Texas | OTHER |
Not provided
Not provided
Not provided
Not provided
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Immediate Intervention | Experimental | participants will receive the 6 months intervention immediately |
|
| Arm 2: Delayed Intervention | Experimental | participants will receive the intervention after the 6-month follow-up visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FIB-4 score | a serum-based biomarker of fibrosis | up to 6 months |
Not provided
Not provided
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:
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:
chronic HBV (HBsAg+ or taking anti-HBV therapy), or
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Basen-Engquist, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control Group | Behavioral | 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. |
|
| D008722 | Methods |