NCT05372055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

June 9, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

May 9, 2022

Last Update Submit

June 8, 2023

Conditions

Malignant Pleural EffusionIndwelling Pleural Catheter

Keywords

Malignant Pleural EffusionIndwelling Pleural CatheterPsychosocial

Outcome Measures

Primary Outcomes (2)

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

    Qualitative data

    2 weeks

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

    Qualitative data

    6-8 weeks

Secondary Outcomes (2)

  • Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics

    2 weeks and 6-8 weeks

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

    2 weeks and 6-8 weeks

Study Arms (1)

Indwelling Pleural Catheter

Patients with malignant pleural effusions managed by IPC insertion as per standard of care

Other: Semi-structure interviews

Interventions

Semi-structure interviewsOTHER

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

Indwelling Pleural Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (19)

  • American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available.

    PMID: 11069845BACKGROUND

  • Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.

    PMID: 20696691BACKGROUND

  • Feller-Kopman DJ, Reddy CB, DeCamp MM, Diekemper RL, Gould MK, Henry T, Iyer NP, Lee YCG, Lewis SZ, Maskell NA, Rahman NM, Sterman DH, Wahidi MM, Balekian AA. Management of Malignant Pleural Effusions. An Official ATS/STS/STR Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Oct 1;198(7):839-849. doi: 10.1164/rccm.201807-1415ST.

    PMID: 30272503BACKGROUND

  • Bibby AC, Dorn P, Psallidas I, Porcel JM, Janssen J, Froudarakis M, Subotic D, Astoul P, Licht P, Schmid R, Scherpereel A, Rahman NM, Maskell NA, Cardillo G. ERS/EACTS statement on the management of malignant pleural effusions. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):116-132. doi: 10.1093/ejcts/ezy258.

    PMID: 30060030BACKGROUND

  • Ayaz-Alkaya S. Overview of psychosocial problems in individuals with stoma: A review of literature. Int Wound J. 2019 Feb;16(1):243-249. doi: 10.1111/iwj.13018. Epub 2018 Nov 4.

    PMID: 30392194BACKGROUND

  • Michálková H. PSYCHOSOCIAL PROBLEMS OF STOMA CLIENTS. :9.

    BACKGROUND

  • Di Gesaro A. The psychological aspects of having a stoma: a literature review. Gastrointestinal Nursing. 2016 Mar 2;14(2):38-44.

    BACKGROUND

  • Moller T, Adamsen L. Hematologic patients' clinical and psychosocial experiences with implanted long-term central venous catheter: self-management versus professionally controlled care. Cancer Nurs. 2010 Nov-Dec;33(6):426-35. doi: 10.1097/NCC.0b013e3181dc1908.

    PMID: 20562617BACKGROUND

  • Stern JM, Jacyna N, Lloyd DA. Review article: psychological aspects of home parenteral nutrition, abnormal illness behaviour and risk of self-harm in patients with central venous catheters. Aliment Pharmacol Ther. 2008 May;27(10):910-8. doi: 10.1111/j.1365-2036.2008.03646.x. Epub 2008 Feb 12.

    PMID: 18284646BACKGROUND

  • Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.

    PMID: 22610520BACKGROUND

  • Thomas R, Fysh ETH, Smith NA, Lee P, Kwan BCH, Yap E, Horwood FC, Piccolo F, Lam DCL, Garske LA, Shrestha R, Kosky C, Read CA, Murray K, Lee YCG. Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial. JAMA. 2017 Nov 21;318(19):1903-1912. doi: 10.1001/jama.2017.17426.

    PMID: 29164255BACKGROUND

  • Muruganandan S, Azzopardi M, Fitzgerald DB, Shrestha R, Kwan BCH, Lam DCL, De Chaneet CC, Rashid Ali MRS, Yap E, Tobin CL, Garske LA, Nguyen PT, Stanley C, Popowicz ND, Kosky C, Thomas R, Read CA, Budgeon CA, Feller-Kopman D, Maskell NA, Murray K, Lee YCG. Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial. Lancet Respir Med. 2018 Sep;6(9):671-680. doi: 10.1016/S2213-2600(18)30288-1. Epub 2018 Jul 20.

    PMID: 30037711BACKGROUND

  • Bhatnagar R, Keenan EK, Morley AJ, Kahan BC, Stanton AE, Haris M, Harrison RN, Mustafa RA, Bishop LJ, Ahmed L, West A, Holme J, Evison M, Munavvar M, Sivasothy P, Herre J, Cooper D, Roberts M, Guhan A, Hooper C, Walters J, Saba TS, Chakrabarti B, Gunatilake S, Psallidas I, Walker SP, Bibby AC, Smith S, Stadon LJ, Zahan-Evans NJ, Lee YCG, Harvey JE, Rahman NM, Miller RF, Maskell NA. Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion. N Engl J Med. 2018 Apr 5;378(14):1313-1322. doi: 10.1056/NEJMoa1716883.

    PMID: 29617585BACKGROUND

  • Prieto L, Thorsen H, Juul K. Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. Health Qual Life Outcomes. 2005 Oct 12;3:62. doi: 10.1186/1477-7525-3-62.

    PMID: 16219109BACKGROUND

  • Maslow AH. Motivation and personality. New York: Harper & Row; 1970.

    BACKGROUND

  • Kiger ME, Varpio L. Thematic analysis of qualitative data: AMEE Guide No. 131. Med Teach. 2020 Aug;42(8):846-854. doi: 10.1080/0142159X.2020.1755030. Epub 2020 May 1.

    PMID: 32356468BACKGROUND

  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006 Jan 1;3:77-101.

    BACKGROUND

  • Rehman KU, Liang J, Sivakumar P. P103 Provision of pleural disease care in the pandemic era: A single centre experience. Thorax. 2021 Nov 1;76(Suppl 2):A123-A123.

    BACKGROUND

  • Zhang J, Liang J, Agoramoorthy L, Montalvo S, Kadwani O, Radcliffe G, Sivakumar P. Psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions: a thematic analysis. BMJ Open Respir Res. 2025 Jul 8;12(1):e002993. doi: 10.1136/bmjresp-2024-002993.

    PMID: 40628689DERIVED

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Parthipan Sivakumar, BM,BSc

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 12, 2022

Study Start

May 9, 2022

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

June 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)