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OpenTrials
Completed

NCT Number: NCT01188746

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

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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Key information

Conditions

Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Determine if there is change in the QoL

    Time frame: 2 years

    of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.

  2. Determine if there is change in symptoms

    Time frame: 2 years

    of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.

Secondary outcomes

  1. Determine the impact ascites has on quality of life

    Time frame: 2 years

    via patient interviews and how this is affected by catheter placement.

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2010
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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