Clinical trial NCT01188746: Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
Official title: Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ascites
Keywords: catheter
palliative
quality of life
10-059
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine if there is change in the QoL
timeFrame: 2 years
measure: Determine if there is change in symptoms
timeFrame: 2 years
Secondary outcomes:
measure: Determine the impact ascites has on quality of life
timeFrame: 2 years
measure: Monitor and describe post-catheter placement morbidity and mortality.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Piera Robson, RN
role: PRINCIPAL_INVESTIGATOR
References: