Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients

Titre officiel

Evaluation of Short and Long External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions

Sommaire:

Cette étude aura lieu à Ottawa (Ontario) et comptera 100 patients dont les symptômes d’épanchement pleural malin sont traités à l’aide d’un cathéter pleural tunnellisé. L’objectif de cette étude est d’évaluer l’efficacité du cathéter pleural Rocket® court par rapport au modèle long en ce qui a trait à l’auto-évaluation de la qualité de vie des patients, sa facilité d’utilisation, l’incidence des complications et le degré de satisfaction à l’égard du fournisseur de soins de santé.

Description de l'essai

Primary Outcome:

• Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
• Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.

Secondary Outcome:

• Ease of use of the short versus long Rocket® pleural catheter.
• Feasibility: measured by incidence of complications (adverse events reports)

Pleural effusion is a medical condition, which occurs when too much fluid collects in the space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath), cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the body) are now commonly used to treat the symptoms of malignant pleural effusions by draining this extra fluid on a daily basis. This drainage can be done and home and need not be performed at a hospital.

The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food and Drug Administration (FDA) and Health Canada for the management of malignant pleural effusions.

This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. All information required to evaluate the Rocket® catheter will be collected from routine medical follow-up visits. The period of time for the study is approximately 4 weeks (28 days).

The Rocket® catheter will be provided to patients who wish to participate in this study. If patients do not wish to participate, they will receive the current standard of care (the PleurX catheter) and will undergo the same standard medical assessments that will be performed in this study.

All patients eligible for the study will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm.

Voir cet essai sur ClinicalTrials.gov