ACTIVE_NOT_RECRUITING

Liver Cancer Prevention Randomized Control Trial

Conditions

Liver Diseases Fibrosis, Liver Cirrhosis, Liver

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease

Quick Facts

Study Start:2022-02-11

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05196867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Waist circumference ≥90/80 cm 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 or specific drug treatment 4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15 1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or 2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy)	1. Pregnant or planning to become pregnant in next 12 months (by self-report) 2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet 3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet 4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver 5. AUDIT-10 score \>15 6. Family or household member already enrolled into study

Inclusion Criteria

Exclusion Criteria

1. Waist circumference ≥90/80 cm 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 or specific drug treatment
4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or
2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy)

1. Pregnant or planning to become pregnant in next 12 months (by self-report)
2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver
5. AUDIT-10 score \>15
6. Family or household member already enrolled into study

Contacts and Locations

Principal Investigator

Karen Basen-Engquist, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Karen Basen-Engquist, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-11

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2022-02-11

Study Completion Date2025-08-30

Terms related to this study

Additional Relevant MeSH Terms

Liver Diseases
Fibrosis, Liver
Cirrhosis, Liver