Overview

This trial is active, not recruiting.

Condition ascites
Treatment mcgill quality of life questionnaire and the european organization for research and treatment of cancer quality of life core questionnaire
Sponsor Memorial Sloan Kettering Cancer Center
Start date August 2010
End date August 2017
Trial size 50 participants
Trial identifier NCT01188746, 10-059

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
A pre-experimental design was chosen to examine changes in QoL following a palliative intervention.
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.

Primary Outcomes

Measure
Determine if there is change in the QoL
time frame: 2 years
Determine if there is change in symptoms
time frame: 2 years

Secondary Outcomes

Measure
Determine the impact ascites has on quality of life
time frame: 2 years
Monitor and describe post-catheter placement morbidity and mortality.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
Principal investigator Piera Robson, RN
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.