Cirrhoses, LiverALLEVIATE-CNCT07792850
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
A study testing High-touch self-management program and Low-touch self-management program in people with Cirrhoses, Liver, run by University of Pennsylvania at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhoses, Liver
- What is being tested?
- High-touch self-management program and Low-touch self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jan 2027to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Samantha Nikirk, MPH, 734-232-4182, samjwalk@med.umich.edu
Elliot Tapper, MD
John Hopkins University
Baltimore, Maryland, 21205
Lisa Datta, 443-831-1940, ldatta1@jh.edu
Alexandra Strauss, MD, PhD
University of Miami
Miami, Florida, 33136
Hanna Garcia, 305-243-9944, goldberglab@miami.edu
David Goldberg, MD
Vanderbilt University
Nashville, Tennessee, 37232
Ashley Spann, MD, MS, 615-421-6137, ashley.spann@vumc.org
Ashley Spann, MD, MS
Columbia University
New York, New York, 10032
Geena Heitmann, MPH, 212-305-3839, gg2827@cumc.columbia.edu
Elizabeth Verna, MD
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Richard Mason, PharmD, 215-349-8986, Richard.Mason@pennmedicine.upenn.edu
Jacqueline Theroux, MPH, 2156623904, Jacqueline.Theroux@pennmedicine.upenn.edu
Mayo Clinic
Rochester, Minnesota, 55905
Amy Olofson, RN, 507-538-6547, olofson.amy@mayo.edu
Douglas Simonetto, MD
University of California San Francisco
San Francisco, California, 94143
Rayshawnda Davis, MS, rayshawnda.davis@ucsf.edu
Jessica Rubin, MD, MPH
About this study
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?
Read more
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
Read the detailed description
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C) is a multicenter, individual-level, parallel-arm, 1:1 randomized superiority trial with a 4-week run-in period followed by 48 weeks of intervention and follow-up. The study will compare effectiveness of a high-touch vs low-touch self-management program to treat chronic pain among patients with cirrhosis.
Participants in the high-touch arm 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.
Participants in the low-touch arm receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Remote or in-person follow up study visits will occur at 12, 24, 36, and 48 weeks.
Endpoints include:
- Primary: Change from baseline in pain interference over 48 weeks (measured using the Pain, Enjoyment of Life, and General Activity (PEG) scale).
- Secondary: Health-related quality of life, cognitive function, average daily step count, pain-related disability, nociplastic pain, cumulative exposure to potentially risky medications, days alive and out of the hospital, pain management strategies, intervention engagement, and care partner burden.
- Implementation: Acceptability, feasibility, intervention fidelity, and barriers and facilitators to implementation.
- Conditions
- Cirrhoses, Liver
- Being tested
- High-touch self-management program, Low-touch self-management program
- Keywords
- cirrhosis, liver, pain management, chronic pain, cirrhosis pain, hepatology, interventional, meditation, walking
- Medical subject headings
- Fibrosis, Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-touch self-management programBehavioural
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.
Low-touch self-management programBehavioural
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-Touch | Experimental | Participants 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. Receives: Behavioral: High-touch self-management program |
| Low-Touch | Experimental | Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks. Receives: Behavioral: Low-touch self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (9)
Health-related quality of life
Change from baseline in health-related quality of life over 48 weeks, assessed using the PROMIS-29+2 Profile v2.1 (PROPr) domain T-scores (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as the multidomain PROPr summary score.
Most domains of the PROPr are ranked on a scale with a minimum of 1 and a maximum of 5. Scores for domains are assessed differently. For fatigue, anxiety, depression, sleep disturbance, and pain interference, a higher score indicates a worse outcome. For physical function, cognitive function, and ability to participate in social roles, a higher score indicates a better outcome. Pain intensity is separately ranked on a scale of 0 to 10, with a higher score indicating a worse outcome.
Measured: 48 weeks
Average daily step count
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
Measured: 48 weeks
Pain-related disability
Change from baseline in pain-related disability at 48 weeks, measured by the Pain Disability Index (PDI) total score. The PDI is a 7-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
Measured: 48 weeks
Severity of nociplastic pain
Change from baseline in severity of nociplastic pain over 52 weeks, assessed using the Fibromyalgia Severity Score (FSS).
Measured: 52 weeks
Cumulative exposure to potentially risky medications
Change from baseline in cumulative exposure to potentially risky medications over 48 weeks, quantified using the Opioid Total Standardized Dose (TSD) across medication classes relevant to cirrhosis.
Measured: 48 weeks
Days alive and out of the hospital
Days alive and out of the hospital (DAOH) over 48 weeks, incorporating hospitalizations, emergency room (ER) visits, and death.
Measured: 48 weeks
Animal Naming Test
Change in cognitive function, measured by the Animal Naming Test (ANT), over 48 weeks.
Measured: 48 weeks
Patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies
Change from baseline in patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies at 52 weeks, assessed using a structured study-specific pain management inventory.
Measured: 52 weeks
Caregiver burden
Change from baseline in care partner caregiver burden, measured by the 12-item Zarit Burden Interview (ZBI-12), over 48 weeks.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhoses, LiverStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792850
- Sponsor's protocol ID
- MP-2025C1-43619
- Acronym
- ALLEVIATE-C
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
- ClinicalTrials.gov ID
- NCT07792850
- Acronym / sponsor ID
- ALLEVIATE-C / MP-2025C1-43619
- Conditions
- Cirrhoses, Liver
- Keywords
- cirrhosis, liver, pain management, chronic pain, cirrhosis pain, hepatology, interventional, meditation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- 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
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C) is a multicenter, individual-level, parallel-arm, 1:1 randomized superiority trial with a 4-week run-in period followed by 48 weeks of intervention and follow-up. The study will compare effectiveness of a high-touch vs low-touch self-management program to treat chronic pain among patients with cirrhosis.
Participants in the high-touch arm 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.
Participants in the low-touch arm receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Remote or in-person follow up study visits will occur at 12, 24, 36, and 48 weeks.
Endpoints include:
- Primary: Change from baseline in pain interference over 48 weeks (measured using the Pain, Enjoyment of Life, and General Activity (PEG) scale).
- Secondary: Health-related quality of life, cognitive function, average daily step count, pain-related disability, nociplastic pain, cumulative exposure to potentially risky medications, days alive and out of the hospital, pain management strategies, intervention engagement, and care partner burden.
- Implementation: Acceptability, feasibility, intervention fidelity, and barriers and facilitators to implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Touch | Experimental | Behavioral: High-touch self-management programParticipants 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 | Experimental | Behavioral: Low-touch self-management programParticipants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-touch self-management programTailored 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. | Behavioural | High-Touch |
| Low-touch self-management programAccess to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks. | Behavioural | Low-Touch |
Primary outcome
Pain Interference
Time frame: 48 weeks
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.
9 secondary outcomes
Health-related quality of life
Time frame: 48 weeks
Average daily step count
Time frame: 48 weeks
Pain-related disability
Time frame: 48 weeks
Severity of nociplastic pain
Time frame: 52 weeks
Cumulative exposure to potentially risky medications
Time frame: 48 weeks
Days alive and out of the hospital
Time frame: 48 weeks
Animal Naming Test
Time frame: 48 weeks
Patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies
Time frame: 52 weeks
Caregiver burden
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Website to be used in study interventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-touch self-management program and Low-touch self-management program in people with Cirrhoses, Liver, run by University of Pennsylvania at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.