Can coaching and walking ease pain in liver disease?
NCT ID NCT07792850
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests two drug-free programs to help adults with cirrhosis manage everyday pain. One group gets a self-guided digital platform with automated messages, while the other adds personalized coaching, group sessions, and a structured walking or meditation plan. Researchers compare the programs over 48 weeks to see if they lower pain and improve quality of life. Participants receive a free Fitbit to track activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A high-touch self-management program with personalized coaching, walking or meditation, and digital tools, compared to a low-touch self-guided program.
- What this could lead to
- If it works, this could offer a drug-free way to reduce pain and improve daily life for people with cirrhosis, potentially reducing reliance on pain medications.
- What could go wrong
- The trial is early and compares two behavioral programs, so the high-touch version may not prove more effective than the simpler one. Results depend on participants sticking with the program.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 625 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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., sorafenib, atezolizumab/bevacizumab, durvalumab/tremelimumab, regorafenib, cabozantinib). 6. \> 2 paracenteses within 56 days prior to consent. 7. Fontan-associated liver disease without cirrhosis on biopsy. 8. Inpatient hospital admission lasting \> 24 hours within 28 days prior to consent. 9. Active metastatic solid malignancy or acute leukemia within 3 years prior to consent. 10. Estimated life expectancy \< 1 year, as determined by the study investigator. 11. Planned living donor liver transplantation within 12 weeks of enrollment. 12. Routine meditation practice, defined as meditation occurring weekly or more frequently. 13. 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. 14. Concurrent enrollment in another nonpharmacologic pain management study or formal pain management program utilizing nonpharmacologic approaches. 15. Deemed unsuitable for participation by the study investigator. 16. Prisoners. Care Partner Inclusion Criteria 1. Age \> 18 years of age. 2. Informal caregiver of a participant enrolled in ALLEVIATE-C 3. Ability to speak and read English or Spanish. Care Partner Exclusion Criteria 1. 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. 2. Deemed unsuitable for participation by the study investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University
New York, New York, 10032, United States
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John Hopkins University
Baltimore, Maryland, 21205, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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University of California San Francisco
San Francisco, California, 94143, United States
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University of Miami
Miami, Florida, 33136, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Vanderbilt University
Nashville, Tennessee, 37232, United States
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