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Completed

NCT Number: NCT05372055

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

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.

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Key information

Conditions

Malignant Pleural Effusion Indwelling Pleural Catheter Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structure interviews

Other

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

Primary outcomes

  1. The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions

    Time frame: 2 weeks

    Qualitative data

  2. The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions

    Time frame: 6-8 weeks

    Qualitative data

Secondary outcomes

  1. 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. Links between psychosocial impact experienced by patients and their IPC care characteristics

    Time frame: 2 weeks and 6-8 weeks

    Qualitative data

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: MY-IPC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 12, 2022
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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