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

NCT03403855 | Unknown

• 1 other identifier: 20170753-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ease of use 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)

  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 Outcomes (1)

• Levels of Satisfaction with the device

  Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.

Study Arms (2)

Rocket® IPC- Long External Length

EXPERIMENTAL

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- Short External Length

EXPERIMENTAL

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

Interventions

Rocket® IPC- Long External Length DEVICE

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

Rocket® IPC- Long External Length

Rocket® IPC- Short External Length DEVICE

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

Rocket® IPC- Short External Length

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Kayvan Amjadi, MD

  Director Interventional Pulmonology, TOH (General Campus)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalie Labelle, MSc

CONTACT

613-737-8899; rolabelle@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: January 19, 2018
• Study Start: March 7, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)