The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
ALLEVIATE-C
1 other identifier
interventional
625
1 country
8
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
Study Completion
Last participant's last visit for all outcomes
June 1, 2030
August 28, 2026
August 1, 2026
3.2 years
August 14, 2026
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Interference
Change from baseline in pain interference over 48 weeks, measured by repeated assessments using the Pain, Enjoyment of life, and General activity (P.E.G.) scale at 12, 24, 36, and 48 weeks, and compared between the two groups. The PEG is a three-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
48 weeks
Secondary Outcomes (9)
Health-related quality of life
48 weeks
Average daily step count
48 weeks
Pain-related disability
48 weeks
Severity of nociplastic pain
52 weeks
Cumulative exposure to potentially risky medications
48 weeks
- +4 more secondary outcomes
Study Arms (2)
High-Touch
EXPERIMENTALParticipants receive tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. The high-touch arm also includes on-demand coaching for low-pain self-efficacy and optional group coaching sessions.
Low-Touch
EXPERIMENTALParticipants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Interventions
Tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. On-demand coaching for low-pain self-efficacy and optional group coaching sessions.
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Patient-Centered Outcomes Research Institutecollaborator
- University of Michigancollaborator
- University of Miamicollaborator
- Johns Hopkins Universitycollaborator
- Columbia Universitycollaborator
- University of California, San Franciscocollaborator
- Vanderbilt University Medical Centercollaborator
- Mayo Cliniccollaborator
Study Sites (8)
University of California San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
John Hopkins University
Baltimore, Maryland, 21205, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Columbia University
New York, New York, 10032, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2026
First Posted
August 28, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Results submitted to ClinicalTrials.gov or other applicable database: 9/1/2030 Contract term date: 3/31/2032
- Access Criteria
- Results submitted to ClinicalTrials.gov or other applicable database
Dissemination of results from this trial will be conducted in accordance with policies and procedures established by the Executive Committee. All abstracts, presentations, and manuscripts arising from this study will be reported to the Patient-Centered Outcomes Research Institute (PCOR)I in compliance with contractual requirements. Fundamentally, PCORI's Policy for Data Management and Data Sharing articulates PCORI's expectation that Awardees make data and data documentation (Full Data Package) from their PCORI-funded research projects available to third-party requestors. The deposition is centered around the Full Data Package, which is comprised of the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from a PCORI-funded research project.