Clinical trial NCT05372055: Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Official title: Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Effusion
Indwelling Pleural Catheter
Keywords: Malignant Pleural Effusion
Indwelling Pleural Catheter
Psychosocial
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with symptomatic malignant pleural effusions treated with indwelling pleural catheter insertion

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.

Eligibility criteria: 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

Primary outcomes:
measure: The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
timeFrame: 2 weeks
measure: The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics
timeFrame: 2 weeks and 6-8 weeks
measure: Links between psychosocial impact experienced by patients and their IPC care characteristics
timeFrame: 2 weeks and 6-8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Parthipan Sivakumar, BM,BSc
role: PRINCIPAL_INVESTIGATOR
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