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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indwelling Pleural Catheter | Patients with malignant pleural effusions managed by IPC insertion as per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics | Qualitative data | 2 weeks and 6-8 weeks |
| Links between psychosocial impact experienced by patients and their IPC care characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with symptomatic malignant pleural effusions treated with indwelling pleural catheter insertion
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| Name | Affiliation | Role |
|---|---|---|
| Parthipan Sivakumar, BM,BSc | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11069845 | Background | 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. | |
| 20696691 | Background | 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. |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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Qualitative data
| 2 weeks and 6-8 weeks |
| 30272503 | Background | 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. |
| 30060030 | Background | 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. |
| 30392194 | Background | 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. |
| Background | 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. |
| 20562617 | 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. |
| 18284646 | Background | 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. |
| 22610520 | Background | 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. |
| 29164255 | Background | 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. |
| 30037711 | Background | 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. |
| 29617585 | Background | 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. |
| 16219109 | Background | 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. |
| Background | Maslow AH. Motivation and personality. New York: Harper & Row; 1970. |
| 32356468 | 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. |
| Background | 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. |
| 40628689 | Derived | 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. |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |