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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Device: Rocket® IPC- Long External Length; Device: Rocket® IPC- Short External Length

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital, General Campus
      • Principal Investigator: Kayvan Amjadi, MD
      • Contact: Rosalie Labelle, MSc; Phone Number: 75256 613-737-8899; Email: rolabelle@toh.ca
      • Sub-Investigator: Pen Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Questionnaire will be administered at routine medical visits on day O, 14, and 28.
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Satisfaction with the device	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.	Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Kayvan Amjadi, MD, Director Interventional Pulmonology, TOH (General Campus)

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: 20170753-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No