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

Primary Purpose

Malignant Pleural Effusion

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rocket® IPC- Long External Length
Rocket® IPC- Short External Length
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Hospital, General CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rocket® IPC- Long External Length

Rocket® IPC- Short External Length

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 31, 2017
Last Updated
September 23, 2020
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03403855
Brief Title
Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocket® IPC- Long External Length
Arm Type
Experimental
Arm Description
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.
Arm Title
Rocket® IPC- Short External Length
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rocket® IPC- Long External Length
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Rocket® IPC- Short External Length
Intervention Description
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 Measure Information:
Title
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
Description
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.
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.
Title
Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Ease of use of the short versus long Rocket® pleural catheter.
Description
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.
Time Frame
Questionnaire will be administered at routine medical visits on day O, 14, and 28.
Title
Feasibility: measured by incidence of complications (adverse events reports)
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Levels of Satisfaction with the device
Description
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.
Time Frame
Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE Persistent malignant pleural effusion that is free flowing Life expectancy of at least 2 months (approximate duration of follow-up for the study) Age greater than 18 Consent to undergoing TPC treatment for recurrent MPE Exclusion Criteria: Prior attempted chemical pleurodesis on ipsilateral side Active pleural or pulmonary infection Currently hospitalized for reasons other than MPE or in hospice care Life expectancy estimated at less than 2 months Inability to complete questionnaires (English or French) Refusal to give informed consent Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalie Labelle, MSc
Phone
613-737-8899
Ext
75256
Email
rolabelle@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayvan Amjadi, MD
Organizational Affiliation
Director Interventional Pulmonology, TOH (General Campus)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalie Labelle, MSc
Phone
613-737-8899
Ext
75256
Email
rolabelle@toh.ca
First Name & Middle Initial & Last Name & Degree
Kayvan Amjadi, MD
First Name & Middle Initial & Last Name & Degree
Pen Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers.

Learn more about this trial

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

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