Malignant Pleural EffusionMY-IPCNCT05372055
Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
An observational study of Malignant Pleural Effusion and Indwelling Pleural Catheter, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Indwelling Pleural Catheter
- What is being tested?
- Semi-structure interviews
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2022to 8 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with symptomatic malignant pleural effusions treated with indwelling pleural catheter insertion
Who may be able to join
- 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
Who cannot join
- Inability to consent
- Estimated life expectancy of <4 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)
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.
Read the 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.
- Being tested
- Semi-structure interviews
- Keywords
- Malignant Pleural Effusion, Indwelling Pleural Catheter, Psychosocial
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Indwelling Pleural Catheter | Patients with malignant pleural effusions managed by IPC insertion as per standard of care Receives: Other: Semi-structure interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Qualitative data
Measured: 2 weeks
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Qualitative data
Measured: 6-8 weeks
Secondary outcomes (2)
Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics
Qualitative data
Measured: 2 weeks and 6-8 weeks
Links between psychosocial impact experienced by patients and their IPC care characteristics
Qualitative data
Measured: 2 weeks and 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start9 May 2022
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parthipan Sivakumar, BM,BSc, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372055
- Sponsor's protocol ID
- 313971
- Acronym
- MY-IPC
- Status last verified
- Mar 2023
- First submitted
- 9 May 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11069845Roberts 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.
PubMed 20696691Feller-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.
PubMed 30272503Bibby 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.
PubMed 30060030Ayaz-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.
PubMed 30392194Michálková H. PSYCHOSOCIAL PROBLEMS OF STOMA CLIENTS. :9.
Di Gesaro A. The psychological aspects of having a stoma: a literature review. Gastrointestinal Nursing. 2016 Mar 2;14(2):38-44.
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.
PubMed 20562617Stern 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.
PubMed 18284646Davies 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.
PubMed 22610520Thomas 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.
PubMed 29164255Muruganandan 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.
PubMed 30037711Bhatnagar 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.
PubMed 29617585Prieto 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.
PubMed 16219109Maslow AH. Motivation and personality. New York: Harper & Row; 1970.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients (MY-IPC)
- ClinicalTrials.gov ID
- NCT05372055
- Acronym / sponsor ID
- MY-IPC / 313971
- Keywords
- Malignant Pleural Effusion, Indwelling Pleural Catheter, Psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indwelling Pleural Catheter | – | Other: Semi-structure interviewsPatients with malignant pleural effusions managed by IPC insertion as per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with symptomatic malignant pleural effusions treated with indwelling pleural catheter insertion
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to consent
- Estimated life expectancy of <4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structure interviewsSemi-structured interview focusing on psychosocial impact of living with an IPC to be performed at 2 weeks and 6-8 weeks post IPC insertion | Other | Indwelling Pleural Catheter |
Primary outcome
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Time frame: 2 weeks
Qualitative data
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions
Time frame: 6-8 weeks
Qualitative data
2 secondary outcomes
Links between psychosocial impact experienced by patients and their baseline, disease or social characteristics
Time frame: 2 weeks and 6-8 weeks
Links between psychosocial impact experienced by patients and their IPC care characteristics
Time frame: 2 weeks and 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 11069845American 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.
- Background: PubMed 20696691Roberts 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.
- Background: PubMed 30272503Feller-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.
- Background: PubMed 30060030Bibby 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.
- Background: PubMed 30392194Ayaz-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.
- BackgroundMichálková H. PSYCHOSOCIAL PROBLEMS OF STOMA CLIENTS. :9.
- BackgroundDi Gesaro A. The psychological aspects of having a stoma: a literature review. Gastrointestinal Nursing. 2016 Mar 2;14(2):38-44.
- Background: PubMed 20562617Moller 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.
- Background: PubMed 18284646Stern 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.
- Background: PubMed 22610520Davies 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.
- Background: PubMed 29164255Thomas 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.
- Background: PubMed 30037711Muruganandan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parthipan Sivakumar, BM,BSc principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Effusion and Indwelling Pleural Catheter, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The psychosocial impact of living with an indwelling pleural catheter in patients with malignant pleural effusions (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05372055, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.