Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients

Completed

• Conditions: Malignant Pleural Effusion; Indwelling Pleural Catheter
• Interventions: Other: Semi-structure interviews

• Registration Number: NCT05372055
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Status Verified: 2023-03
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indwelling Pleural Catheter	Semi-structure interviews	Patients with malignant pleural effusions managed by IPC insertion as per standard of care

Primary Outcome Measures

Name	Time	Method
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions	6-8 weeks	Qualitative data

Secondary Outcome Measures

Name	Time	Method
Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics	2 weeks and 6-8 weeks	Qualitative data
Links between psychosocial impact experienced by patients and their IPC care characteristics	2 weeks and 6-8 weeks	Qualitative data

Trial Locations

Locations (1)

Guy's & St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom