Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites

Ascites Clinical Trial

Official title:

Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188746
• Other study ID #: 10-059
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.

All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:

Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with a stage IV malignancy or end-stage disease documented in patient's chart.

• Patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a Tenckhoff catheter, a PleurX catheter, or a Denver Shunt.

• Fluency in English to enable instrument and interview completion.

• Patients must be at least 18 years of age.

• Patients must be physically capable of completing instruments and/or interview.

• Patients must be able to comprehend and execute informed consent.

Exclusion Criteria:

• Unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional.

• Proxy completion is not accepted

• Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument

Related Conditions & MeSH terms

• Ascites

Intervention

Behavioral:
• McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
Participants will be interviewed twice (if they chose to participate in the qualitative portion) and complete instruments at three time points: 1) immediately prior to the procedure, 2)within seven days after the procedure, preferably prior to discharge, and 3) three weeks after their catheter placement.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if there is change in the QoL	of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.	2 years
Primary	Determine if there is change in symptoms	of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.	2 years
Secondary	Determine the impact ascites has on quality of life	via patient interviews and how this is affected by catheter placement.	2 years
Secondary	Monitor and describe post-catheter placement morbidity and mortality.		2 years

External Links

•   Memorial Sloan-Kettering Cancer Center