RECRUITING

QOL and Sarcopenia in Patients With Ascites

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites

Quick Facts

Study Start:2023-05-23
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05726747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>/=18
  2. 2. Eastern Cooperative Oncology Group (ECOG) performance score \< 3
  3. 3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
  4. 4. Capable of giving informed consent
  1. 1. Life expectancy less than 3 months
  2. 2. Unable to participate in neuropsychological tests/questionnaires
  3. 3. Pregnant or nursing women. .

Contacts and Locations

Study Contact

Michael C Soulen, MD
CONTACT
2154218647
michael.soulen@pennmedicine.upenn.edu
Kathleen Thomas, MS
CONTACT
215-746-0352
kathleen.thomas@pennmedicine.upenn.edu

Principal Investigator

Michael Soulen, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Michael Soulen, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-05-23
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • ascites
  • sarcopenia

Additional Relevant MeSH Terms

  • Ascites Hepatic
  • Ascites, Malignant