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

Not Applicable

Completed

• Conditions: Ascites
• Interventions: Behavioral: McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire

• Registration Number: NCT01188746
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Questionnaire or interview	McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire	A pre-experimental design was chosen to examine changes in QoL following a palliative intervention.

Primary Outcome Measures

Name	Time	Method
Determine if there is change in the QoL	2 years	of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Determine if there is change in symptoms	2 years	of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.

Secondary Outcome Measures

Name	Time	Method
Determine the impact ascites has on quality of life	2 years	via patient interviews and how this is affected by catheter placement.
Monitor and describe post-catheter placement morbidity and mortality.	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States