The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Not yet recruitingNot applicableNCT07792850
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The goal of this clinical trial is to test a low-touch vs high-touch drug-free pain self-management program that may help lower pain and improve quality of life for adults with cirrhosis and pain. Participants are assigned by chance to one of two study groups. The groups receive different levels of support. The main questions it aims to answer are: * Do the programs help lower pain? * Do the programs improve quality of life? * Is one program more effective than the other? Researchers will compare a low-touch self management program to a high-touch self-management program to see if the programs help manage pain. Participants in the low-touch arm will: * Learn new ways to manage pain without medication * Receive access to the self-guided digital self-management platform * Receive general behavioral text message nudges * Receive a free Fitbit to keep Participants in the high-touch arm will: * Learn new ways to manage pain without medication * Receive tailored access to the self-guided digital self-management platform * Received individualized pain coaching and optional group coaching sessions * Participate in a structured walking or meditation curriculum * Receive a free Fitbit to keep
Study details
- Official title
- The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
- Conditions
- Cirrhoses, Liver
- Interventions
- Behavioral: High-touch self-management program
- Behavioral: Low-touch self-management program
- Sponsor
- University of Pennsylvania
- Collaborators
- Patient-Centered Outcomes Research Institute; University of Michigan; University of Miami; Johns Hopkins University; Columbia University; University of California, San Francisco; Vanderbilt University Medical Center; Mayo Clinic
- Start date
- 2027-01-01
- Primary completion
- 2030-03-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Patient Inclusion Criteria: 1. Age \> 18 years of age. 2. Clinical diagnosis of cirrhosis established by any one of the following: 1. Liver biopsy consistent with cirrhosis. 2. 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 3. History of at least one cirrhosis complication, including variceal hemorrhage, hepatocellular carcinoma (HCC), ascites, or hepatic encephalopathy. 3. Liver transplant recipients are eligible if the transplanted cirrhotic allograft meets the above criteria. 4. Chronic pain, defined as a Pain, Enjoyment of Life, and General Activity (PEG) scale score \> 4, assessed during screening prior to consent. 5. Ability to ambulate (walk), either independently or with the use of assistive devices. 6. Reliable access to Wi-Fi or cellular data. 7. Ownership of, or reliable access to, a smartphone with the ability and willingness to receive study-related text messages. 8. Ability to speak and read English or Spanish. Patient Exclusion Criteria: 1. Acute pain due to injury (e.g., surgery, fracture, trauma, burn) within 28 days. 2. Diagnosed or suspected noncirrhotic portal hypertension. 3. Episode of overt hepatic encephalopathy (HE) within 28 days prior to consent. a. 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. 4. Model for End-Stage Liver Disease - Na (MELD-Na) score \> 25 calculated using the UNOS algorithm. a. Participants with MELD-Na \> 25 due to clinically stable end-stage renal disease (ESRD) may be eligible if total bilirubin \< 5 mg/dL. 5. Advanced hepatocellular carcinoma (HCC) defined as Barcelona Clinic Liver Cancer (BCLC) stage \> C, or current treatment with systemic therapy for HCC (e.g.…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07792850