Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)

June 8, 2023 updated by: Guy's and St Thomas' NHS Foundation Trust

Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)

The purpose of this study is to better understand the impact that Indwelling Pleural Catheters have on patients with malignant pleural effusions from a psychosocial point of view.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, all patients giving written informed consent will undergo a baseline assessment including disease and social characteristics on the day of their Indwelling Pleural Catheter (IPC) insertion. At 2 weeks and 6-8 weeks post insertion, they will be contacted via telephone for a semi-structured interview focusing on the psychosocial impact that the IPC has had on their lives. Data surrounding the medical care of the IPC will also be collected.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with symptomatic malignant pleural effusions treated with indwelling pleural catheter insertion

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Aged 18 years or above
  • Diagnosis of malignant pleural effusion
  • Will be undergoing IPC insertion for management of their malignant pleural effusion
  • Have the means to be contacted and be able to conduct an interview in English via telephone within the study timeframe

Exclusion Criteria:

  • Inability to consent
  • Estimated life expectancy of <4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Indwelling Pleural Catheter
Patients with malignant pleural effusions managed by IPC insertion as per standard of care
Other: Semi-structure interviews
Semi-structured interview focusing on psychosocial impact of living with an IPC to be performed at 2 weeks and 6-8 weeks post IPC insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Time Frame: 2 weeks
Qualitative data
2 weeks
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Time Frame: 6-8 weeks
Qualitative data
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics
Time Frame: 2 weeks and 6-8 weeks
Qualitative data
2 weeks and 6-8 weeks
Links between psychosocial impact experienced by patients and their IPC care characteristics
Time Frame: 2 weeks and 6-8 weeks
Qualitative data
2 weeks and 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Parthipan Sivakumar, BM,BSc, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 313971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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