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

NCT01188746 | Completed

• 1 other identifier: 10-059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascites

Keywords

catheter; palliative; quality of life; 10-059

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Determine the impact ascites has on quality of life

  2 years

• Monitor and describe post-catheter placement morbidity and mortality.

  2 years

Study Arms (1)

Questionnaire or interview

EXPERIMENTAL

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

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

Interventions

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

Questionnaire or interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Piera Robson, RN

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

US (1)