Two drug-free pain programs for adults with cirrhosis and pain

Other criteria

• Patient Inclusion Criteria:
• Age > 18 years of age
• Clinical diagnosis of cirrhosis established by any one of the following:; Liver biopsy consistent with cirrhosis; Noninvasive evidence of cirrhosis, defined as ≥2 of the following criteria:; Imaging (Ultrasound (US), Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)) demonstrating cirrhosis liver morphology (e.g., 'cirrhosis', cirrhotic appearing', 'nodular') with supportive findings (e.g., splenomegaly or recanalized umbilical vein); Transient elastography (TE) (FibroScan) liver stiffness > 12.5 kilopascal (kPa) with IQR/Median <30% or Magnetic resonance elastography > 5.0 kPa; Laboratory evidence including AST/platelet ratio index (APRI) >2.0, FIB-4 >2.67 or Platelet count <150 x 10⁹/L; CT, MRI, or Esophagogastroduodenoscopy (EGD) showing the presence of esophageal varices; History of at least one cirrhosis complication, including variceal hemorrhage, hepatocellular carcinoma (HCC), ascites, or hepatic encephalopathy
• Liver transplant recipients are eligible if the transplanted cirrhotic allograft meets the above criteria
• Chronic pain, defined as a Pain, Enjoyment of Life, and General Activity (PEG) scale score > 4, assessed during screening prior to consent
• Ability to ambulate (walk), either independently or with the use of assistive devices
• Reliable access to Wi-Fi or cellular data
• Ownership of, or reliable access to, a smartphone with the ability and willingness to receive study-related text messages
• Ability to speak and read English or Spanish; Patient Exclusion Criteria:
• Acute pain due to injury (e.g., surgery, fracture, trauma, burn) within 28 days
• Diagnosed or suspected noncirrhotic portal hypertension
• Episode of overt hepatic encephalopathy (HE) within 28 days prior to consent; Overt HE is defined as acute disorientation requiring hospitalization or initiation of HE-directed therapy (e.g., lactulose, fluids, rifaximin) with diagnosis made by a gastroenterologist, hepatologist, or study investigator and resolution following therapy
• Model for End-Stage Liver Disease - Na (MELD-Na) score > 25 calculated using the UNOS algorithm; Participants with MELD-Na > 25 due to clinically stable end-stage renal disease (ESRD) may be eligible if total bilirubin < 5 mg/dL
• Advanced hepatocellular carcinoma (HCC) defined as Barcelona Clinic Liver Cancer (BCLC) stage > C, or current treatment with systemic therapy for HCC (e.g., sorafenib, atezolizumab/bevacizumab, durvalumab/tremelimumab, regorafenib, cabozantinib)
• > 2 paracenteses within 56 days prior to consent
• Fontan-associated liver disease without cirrhosis on biopsy
• Inpatient hospital admission lasting > 24 hours within 28 days prior to consent
• Active metastatic solid malignancy or acute leukemia within 3 years prior to consent
• Estimated life expectancy < 1 year, as determined by the study investigator
• Planned living donor liver transplantation within 12 weeks of enrollment
• Routine meditation practice, defined as meditation occurring weekly or more frequently
• Inability to participate in study procedures, including inability to read study materials, cognitive impairment, or psychiatric illness that would preclude participation in the opinion of the investigator
• Concurrent enrollment in another nonpharmacologic pain management study or formal pain management program utilizing nonpharmacologic approaches
• Deemed unsuitable for participation by the study investigator
• Prisoners; Care Partner Inclusion Criteria
• Age > 18 years of age
• Informal caregiver of a participant enrolled in ALLEVIATE-C
• Ability to speak and read English or Spanish; Care Partner Exclusion Criteria
• Inability to participate in study procedures, including inability to read study materials, cognitive impairment, or psychiatric illness that would preclude participation in the opinion of the investigator
• Deemed unsuitable for participation by the study investigator