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

Malignant Pleural Effusion Clinical Trial

— MY-IPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372055
• Other study ID #: 313971
• Status: Completed
• Start date: May 9, 2022
• Est. completion date: May 8, 2023

Study information

• Verified date: March 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions	Qualitative data	2 weeks
Primary	The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions	Qualitative data	6-8 weeks
Secondary	Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics	Qualitative data	2 weeks and 6-8 weeks
Secondary	Links between psychosocial impact experienced by patients and their IPC care characteristics	Qualitative data	2 weeks and 6-8 weeks