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

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ClinicalTrials.gov Identifier: NCT03403855
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Device: Rocket® IPC- Long External Length Device: Rocket® IPC- Short External Length Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

All patients 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. Patient satisfaction will be collected at 2 weeks prior to the modification, and 4 weeks when the patient has a shorter catheter.

The modification is easily done without any use of anesthesia as it is external to the patient. It is done with the tool kit that comes along with the catheter.

All patients will be referred to palliative home care services for assistance with drainage. Drainage catheters are usually provided by Ontario Medical Supplies. However, the drainage catheters to be used in this study will be those supplied by Rocket Medical Inc., as they will be providing Dr. Amjadi with some samples to evaluate their product.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Rocket® IPC- Long External Length

Intervention Rocket® IPC- Long External Length: a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter.

The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter.

Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate their product.

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

Experimental: Rocket® IPC- Short External Length

Intervention Rocket® IPC- Short External Length : a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter.

The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter.

Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate Rocket's product.

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




Primary Outcome Measures :
  1. Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion. [ Time Frame: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28. ]

    Self-rated QOL at baseline compared to 2 weeks and 4 weeks post catheter insertion.

    Quality of life will be assessed using the validated EORTC QLQ-C30 (European Organization of Research and Treatment of Cancer Quality of Life Evaluation) questionnaire.


  2. Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion. [ Time Frame: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28. ]

    Self-rated QOL in domains specific to lung cancer will be assessed at baseline compared to 2 weeks and 4 weeks post catheter insertion.

    Quality of life will be assessed using the validated lung cancer specific EORTC QLQ-LC13 (European Organization of Research and Treatment of Cancer (EORTC) Quality of Life QLQ-LC13 disease specific) questionnaire.



Secondary Outcome Measures :
  1. Ease of use of the short versus long Rocket® pleural catheter. [ Time Frame: Questionnaire will be administered at routine medical visits on day O, 14, and 28. ]

    Ease of use of the short versus long Rocket pleural catheter as reported by the study doctor as well as the hospital and home care nursing staff.

    Ease of use will be measured using a non-validated questionnaire, which will assess the functionality of the short versus long Rocket® pleural catheter.


  2. Feasibility: measured by incidence of complications (adverse events reports) [ Time Frame: Complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments). Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28. ]

    Feasibility will be measured by the incidence of complications found in patients using short versus long Rocket® pleural catheters to treat symptoms of MPE as well as hospital and home care nursing staffs' level of satisfaction with the Rocket® catheter.

    The time to removal of the Rocket catheter will also be followed and complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments) and ongoing reports from home care nurses. All complications will be documented, the most clinically relevant include pleural infection and cellulitis, pain, and catheter obstruction and symptomatic loculated effusion.



Other Outcome Measures:
  1. Levels of Satisfaction with the device [ Time Frame: Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28. ]
    Levels of satisfaction with the Rocket® catheter will be measured using a non-validated questionnaire which will assess comfort with the short versus long Rocket® pleural catheter.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
  2. Persistent malignant pleural effusion that is free flowing
  3. Life expectancy of at least 2 months (approximate duration of follow-up for the study)
  4. Age greater than 18
  5. Consent to undergoing TPC treatment for recurrent MPE

Exclusion Criteria:

  1. Prior attempted chemical pleurodesis on ipsilateral side
  2. Active pleural or pulmonary infection
  3. Currently hospitalized for reasons other than MPE or in hospice care
  4. Life expectancy estimated at less than 2 months
  5. Inability to complete questionnaires (English or French)
  6. Refusal to give informed consent
  7. Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403855


Contacts
Contact: Rosalie Labelle, MSc 613-737-8899 ext 75256 rolabelle@toh.ca

Locations
Canada, Ontario
Ottawa Hospital, General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Rosalie Labelle, MSc    613-737-8899 ext 75256    rolabelle@toh.ca   
Principal Investigator: Kayvan Amjadi, MD         
Sub-Investigator: Pen Li, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Kayvan Amjadi, MD Director Interventional Pulmonology, TOH (General Campus)

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03403855     History of Changes
Other Study ID Numbers: 20170753-01H
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms