266 Participants Needed

Disease Management Education for Liver Cancer Prevention

KB
Overseen ByKaren Basen-Engquist, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23678

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.1691011

Research Team

KB

Karen Basen-Engquist, MD

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

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

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
  • Control Group
Trial Overview 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.
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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials
55
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.
Informal education and health promoting approaches in adult cancer survivors.Argyriou, AA., Ifanti, AA., Kalofonos, H.[2012]
Behavioral risk factors like tobacco use, diet, physical activity, and obesity are linked to cancer, but effective interventions can significantly reduce cancer incidence, as seen in the recent decline in lung cancer rates.
Successful cancer prevention strategies incorporate multiple components, such as individual and family activities, community involvement, and are guided by behavioral theories that emphasize self-efficacy and social support.
Behavior and cancer prevention.Gotay, CC.[2022]
Behavioral interventions, such as breathing exercises that focus on diaphragm use and altering breathing rhythms, can significantly help lung cancer patients manage feelings of breathlessness and improve their quality of life.
Oncology professionals should incorporate these psychosocially oriented strategies alongside medical treatments to effectively address the debilitating symptom of breathlessness in lung cancer patients.
Behavioral interventions for lung cancer-related breathlessness.Gallo-Silver, L., Pollack, B.[2019]

References

Informal education and health promoting approaches in adult cancer survivors. [2012]
Behavior and cancer prevention. [2022]
Behavioral interventions for lung cancer-related breathlessness. [2019]
Critical review of psychosocial interventions in cancer care. [2022]
'Weighing' Losses and Gains: Evaluation of the Healthy Lifestyle Modification After Breast Cancer Pilot Program. [2023]
Impact of a primary care intervention on smoking, drinking, diet, weight, sun exposure, and work risk in families with cancer experience. [2015]
Feasibility Study to Assess the Impact of a Lifestyle Intervention during Colorectal Cancer Screening in France. [2021]
Advances in behavioral intervention in comprehensive cancer treatment. [2019]
[Therapeutic education in oncology: involving patient in the management of cancer]. [2011]
Psychoeducation for breast cancer: A systematic review and meta-analysis. [2022]
Patient education at a distance. [2021]