Only 25 spots left

~25 spots leftby Aug 2025

Disease Management Education for Liver Cancer Prevention

Recruiting in Palo Alto (17 mi)

Karen M. Basen-Engquist | MD Anderson ...

Overseen byKaren M. Basen-Engquist

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Liver cancer, Recent surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants can be on specific drug treatments for conditions like high blood pressure, high triglycerides, or low HDL-cholesterol, so it seems likely that some medications may be continued.

What data supports the effectiveness of this treatment for liver cancer prevention?

Research shows that behavioral interventions, like those used in this study, can effectively reduce cancer risk by addressing lifestyle factors such as diet, exercise, and smoking. These interventions have been successful in promoting healthier lifestyles and improving quality of life in cancer survivors, which may help in preventing liver cancer.¹ ² ³ ⁴ ⁵

Is the Disease Management Education for Liver Cancer Prevention generally safe for humans?

Behavioral interventions, like those used in cancer prevention and management, are generally considered safe for humans. They focus on lifestyle changes such as diet, physical activity, and smoking cessation, which have been shown to be effective and safe in reducing cancer risk and managing symptoms.² ³ ⁶ ⁷ ⁸

How is the behavioral intervention treatment for liver cancer prevention different from other treatments?

The behavioral intervention for liver cancer prevention is unique because it focuses on lifestyle changes, such as diet and exercise, rather than medication. This approach aims to empower patients to manage their health through education and behavior modification, which can improve overall quality of life and potentially reduce cancer risk.¹ ⁶ ⁹ ¹⁰ ¹¹

Research Team

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

My tests show I have liver fibrosis or fat in my liver.

Exclusion Criteria

Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet

Family or household member already enrolled into study

I have or had liver cancer or cancer that has spread to my liver.

See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants receive a 6-month self-management intervention to help implement behavioral changes to manage their disease

6 months

Delayed Intervention

Participants in the wait-list control group receive the intervention after their 6-month assessment

6 months

Follow-up

Participants are monitored for changes in fibrosis and behavioral risk factors after the intervention

6 months

Treatment Details

Interventions

Behavioral Intervention (Behavioural Intervention)
Control Group (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

MD Anderson Cancer CenterHouston, TX

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Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

Patients Recruited

98,900+

Findings from Research

Many cancer survivors continue to engage in risky health behaviors after diagnosis, which can increase the risk of cancer recurrence, but there is a growing trend towards receiving better risk-based medical care.

Informal education approaches, including diet, exercise, and cessation of unhealthy habits, have shown promise in improving the well-being and quality of life of cancer survivors, although more research is needed to confirm the long-term effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informal education and health promoting approaches in adult cancer survivors.Argyriou, AA., Ifanti, AA., Kalofonos, H.[2012]

Psychoeducation significantly reduced anxiety levels and improved the quality of life (QoL) for women with breast cancer, based on a meta-analysis of 27 randomized controlled trials involving 7742 participants.

However, psychoeducation did not show a significant impact on adherence to diagnostic procedures, treatment, depression, or breast cancer knowledge, indicating its benefits may be more focused on emotional support rather than treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis.Setyowibowo, H., Yudiana, W., Hunfeld, JAM., et al.[2022]