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Behavioural Intervention

Disease Management Education for Liver Cancer Prevention

N/A
Recruiting
Led By Karen Basen-Engquist
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of at least 1 risk factor for cirrhosis: a. chronic HBV (HBsAg+ or taking anti-HBV therapy) b. chronic HCV (HCV RNA detectable or taking anti-HCV therapy) c. Meets metabolic criteria for metabolic dysfunction-associated fatty liver disease (MAFLD) i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), ii. presence of type II diabetes mellitus iii. presence of at least two metabolic risk abnormalities 1. Waist circumference >90/80cm 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 (>1.70 mmol/L) or specific drug treatment 4. Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl [5.6-6.9 mmol/L], or 2-hour post-load glucose levels 140-199 mg/dl [7.8-11.0 mmol] or HbA1c 5.7%-6.4% [39-47 mmol/mol]) d. AUDIT-C >4 for men and >3 for women AND AUDIT-10 = 8-15 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
Evidence of liver fibrosis (Liver fibrosis serum biomarker (FIB-4) index > 1.3 or Liver fibrosis grade > F2 by fibroscan) or hepatic steatosis (CAP score > 290)
Must not have
Current or prior history of primary liver cancer or cancer that is metastatic to the liver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new way to help people with liver disease by teaching them how to manage their disease and risks.

Who is the study for?
Adults with liver fibrosis or steatosis and risk factors for cirrhosis, such as chronic hepatitis B or C, diabetes, high triglycerides, pre-diabetes, obesity, or metabolic abnormalities. Participants must be over 18 years old and able to communicate in English or Spanish. They need smartphone access but cannot join if pregnant, planning pregnancy soon, have exercise/diet restrictions due to medical conditions or surgery plans.
What is being tested?
The trial is testing a tailored disease management program that uses behavior modification to prevent liver cancer in patients at risk of developing cirrhosis. It involves two groups: one receiving the intervention and another serving as a control group without the special program.
What are the potential side effects?
Since this trial focuses on lifestyle interventions rather than medication, side effects may include discomfort from changes in diet and exercise routines. However specific side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tests show I have liver fibrosis or fat in my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had liver cancer or cancer that has spread to my liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in FIB-4 score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Delayed InterventionExperimental Treatment1 Intervention
participants will receive the intervention after the 6-month follow-up visit
Group II: Arm 1: Immediate InterventionExperimental Treatment1 Intervention
participants will receive the 6 months intervention immediately
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Group
2020
Completed Phase 2
~7240
Control Group
2012
Completed Phase 2
~2470

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,343 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
53 Previous Clinical Trials
98,778 Total Patients Enrolled
Karen Basen-EngquistPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Behavioral Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05196867 — N/A
Liver Disease Research Study Groups: Arm 2: Delayed Intervention, Arm 1: Immediate Intervention
Liver Disease Clinical Trial 2023: Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05196867 — N/A
Behavioral Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05196867 — N/A
~57 spots leftby Aug 2025
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