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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2020-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Ascites

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Questionnaire or interview

A pre-experimental design was chosen to examine changes in QoL following a palliative intervention.

Group Type EXPERIMENTAL

McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No