Back to resultsImpact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
Primary Purpose
Ascites
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Ascites focused on measuring catheter, palliative, quality of life, 10-059
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Questionnaire or interview
Arm Description
A pre-experimental design was chosen to examine changes in QoL following a palliative intervention.
Outcomes
Primary Outcome Measures
Determine if there is change in the QoL
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Determine if there is change in symptoms
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Secondary Outcome Measures
Determine the impact ascites has on quality of life
via patient interviews and how this is affected by catheter placement.
Monitor and describe post-catheter placement morbidity and mortality.
Full Information
NCT ID
NCT01188746
First Posted
August 24, 2010
Last Updated
February 5, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01188746
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites
Keywords
catheter, palliative, quality of life, 10-059
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire or interview
Arm Type
Experimental
Arm Description
A pre-experimental design was chosen to examine changes in QoL following a palliative intervention.
Intervention Type
Behavioral
Intervention Name(s)
McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
Intervention Description
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 Outcome Measure Information:
Title
Determine if there is change in the QoL
Description
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Time Frame
2 years
Title
Determine if there is change in symptoms
Description
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine the impact ascites has on quality of life
Description
via patient interviews and how this is affected by catheter placement.
Time Frame
2 years
Title
Monitor and describe post-catheter placement morbidity and mortality.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piera Robson, RN
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
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