MY-IPC: Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05372055
Collaborator
(none)
20
12
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)
Anticipated Study Start Date
:
Jun 1, 2022
Anticipated Primary Completion Date
:
Jun 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Indwelling Pleural Catheter Patients with malignant pleural effusions managed by IPC insertion as per standard of care |
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
|
Outcome Measures
Primary Outcome Measures
- The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions [2 weeks]
Qualitative data
- The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions [6-8 weeks]
Qualitative data
Secondary Outcome Measures
- Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics [2 weeks and 6-8 weeks]
Qualitative data
- Links between psychosocial impact experienced by patients and their IPC care characteristics [2 weeks and 6-8 weeks]
Qualitative data
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
Investigators
- Principal Investigator: Parthipan Sivakumar, BM,BSc, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
- American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001.
- 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. Review.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- Maslow AH. Motivation and personality. New York: Harper & Row; 1970.
- Michálková H. PSYCHOSOCIAL PROBLEMS OF STOMA CLIENTS. :9.
- Møller 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05372055
Other Study ID Numbers:
- 313971
First Posted:
May 12, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust
Additional relevant MeSH terms: