Disease Management Education for Liver Cancer Prevention

Overseen By Karen Basen-Engquist, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Liver cancer, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new educational program to help individuals manage liver conditions like fibrosis (scarring) or steatosis (fatty liver) to prevent liver cancer. Participants will receive information on lifestyle changes, such as diet and exercise, through a series of text messages. The trial includes two groups: one will begin the Behavioral Intervention program immediately, while the other will start after six months. Individuals with liver issues who are overweight, have diabetes, or exhibit certain metabolic risks may be suitable candidates if they have a smartphone and can receive text messages. As an unphased trial, this study provides a unique opportunity to contribute to innovative educational approaches for liver health management.

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 prior data suggests that this behavioral intervention is safe?

Research shows that the types of behavioral programs used in this trial are usually easy for people to handle. Studies on lifestyle changes indicate that these programs can lead to positive short-term health benefits without major safety issues. Reports have not indicated negative effects from these programs, as they mainly involve changes in diet, exercise, and health education.

Although these programs might not always result in permanent lifestyle changes, they are considered safe for participants. Evidence suggests that participants should not expect harmful side effects from taking part in these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on a behavioral intervention for liver cancer prevention, offering a new angle compared to traditional methods like surgery, chemotherapy, or targeted therapy. This intervention emphasizes disease management education, aiming to empower participants with knowledge and strategies to prevent liver cancer through lifestyle changes. Unlike conventional treatments that address liver cancer after it develops, this approach seeks to reduce the risk proactively, which could lead to fewer cases and better outcomes in the long run. The trial's unique feature of offering both immediate and delayed interventions allows researchers to compare and understand the timing's impact on effectiveness, potentially refining future prevention strategies.

What evidence suggests that this trial's treatments could be effective for liver cancer prevention?

Research has shown that staying physically active can greatly reduce the risk of hepatocellular carcinoma (HCC), a common type of liver cancer. Regular exercise can lower the risk of HCC by about 30%. Programs that help people change their habits have demonstrated positive short-term results in reducing risk factors for liver diseases. This trial will compare two approaches: an immediate behavioral intervention and a delayed intervention. Although the long-term effects remain unclear, these programs are still important for maintaining liver health. Additionally, mobile health (mHealth) tools effectively share crucial information about preventing liver cancer. These findings suggest that changing behaviors can powerfully manage liver health and prevent cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen Basen-Engquist, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm 2: Delayed Intervention Experimental Treatment 1 Intervention

participants will receive the intervention after the 6-month follow-up visit

Group II: Arm 1: Immediate Intervention Experimental Treatment 1 Intervention

participants will receive the 6 months intervention immediately

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+

Published Research Related to This Trial

A randomized clinical trial involving 3,031 relatives of cancer patients showed that an educational intervention significantly reduced five cancer risk behaviors, including smoking, drinking, poor diet, unhealthy weight, and sun exposure, compared to a control group.

The intervention, based on social cognitive theories, led to a notable decrease in the Total Cancer Behavioral Risk (TCBR) indicator, suggesting that targeted educational efforts in primary care can effectively motivate families to adopt healthier behaviors and reduce cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a primary care intervention on smoking, drinking, diet, weight, sun exposure, and work risk in families with cancer experience. López, ML., Iglesias, JM., del Valle, MO., et al.[2015]

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]

Behavioral interventions play a crucial role in managing side effects of cancer treatments, particularly in reducing nausea and vomiting caused by chemotherapy, which is a primary focus of current research.

These interventions are also being applied to alleviate other distressing symptoms such as anxiety and pain in both adult and pediatric cancer patients, highlighting their importance in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. Redd, WH.[2019]

Therapeutic education in cancer aims to actively involve patients in their treatment decisions and disease management, which can enhance their adjustment to living with cancer as a chronic disease.

Pilot studies suggest that educational programs can improve the quality of life for cancer patients and reduce treatment side effects, highlighting the need for further research to develop and evaluate cancer-specific education programs in France.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education in oncology: involving patient in the management of cancer]. Pérol, D., Toutenu, P., Lefranc, A., et al.[2011]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. Gallo-Silver, L., Pollack, B.[2019]

A feasibility study involving 49 patients undergoing colorectal cancer screening showed that 88% were willing to change their lifestyle to lower cancer risk, indicating a strong interest in lifestyle advice during screening.

Patients found the educational materials easy to understand, and 50% reported adopting at least one healthy behavior within two weeks, suggesting that providing lifestyle recommendations at the time of screening is both acceptable and potentially effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study to Assess the Impact of a Lifestyle Intervention during Colorectal Cancer Screening in France. Huybrechts, I., Kliemann, N., Perol, O., et al.[2021]

In a pilot study involving 14 overweight breast cancer survivors, participants completed a 10-week online intervention that led to an average weight loss of 2.83% and significant improvements in physical activity, intuitive eating habits, and self-efficacy regarding healthy choices.

Despite modest weight loss, the intervention resulted in meaningful psychosocial benefits, including improved body image, increased self-compassion, and empowerment, highlighting the importance of addressing both physical and emotional health in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Weighing' Losses and Gains: Evaluation of the Healthy Lifestyle Modification After Breast Cancer Pilot Program. Male, D., Fergus, K., Yufe, S.[2023]

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]

The study highlights the shift from traditional paternalistic patient education to a more informed approach, emphasizing the importance of educating cancer patients about their treatment options, particularly for those with gynaecological cancers treated with brachytherapy.

It suggests that transitioning from face-to-face education to distance learning can be effective if adult learning principles are applied and communication channels are maintained, ensuring patients receive the support they need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education at a distance. Mitchell, F.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior and cancer prevention. Gotay, CC.[2022]

Patients with cancer are living longer, highlighting the need for diverse psychosocial interventions to support their mental and emotional well-being.

The review identifies four common types of interventions—education, behavioral training, individual psychotherapy, and group interventions—each offering potential psychological and physical health benefits for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of psychosocial interventions in cancer care. Fawzy, FI., Fawzy, NW., Arndt, LA., et al.[2022]

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