QOL and Sarcopenia in Patients With Ascites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality of Life surveys.
- Who it may be relevant to
- Registry conditions: Ascites Hepatic, Ascites, Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites
Overview
Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies. Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites. Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.
Detailed description
Patients with refractory ascites defined as requiring \>1 paracentesis within a 6 week period will be prospectively enrolled. The Patient-Reported Outcomes Measurement Information System (PROMIS-10) and ascites-specific (Ascites Q and Edmonton Symptom Assessment System: Ascites Modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. Sarcopenia will be assessed by muscle area measurement from a single CT image at the L4 level at baseline, 2- and 6 months.
Interventions
- Diagnostic test Quality of Life surveys
QoL and sarcopenia assessments
Primary outcome measures
- Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire [Time frame: 6 months]
- Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas [Time frame: 6 months]
Secondary outcome measures (2)
- Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites. [Time frame: 6 months]
- Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites, [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age >/=18
- Eastern Cooperative Oncology Group (ECOG) performance score < 3
- Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
- Capable of giving informed consent
Exclusion criteria
- Life expectancy less than 3 months
- Unable to participate in neuropsychological tests/questionnaires
- Pregnant or nursing women. .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Pennsylvania Perelman School of Medicine — Philadelphia
Identifiers
NCT: NCT05726747 · UPCC 22222