Interventions for Malignant Pleural Effusions Impact on Fatigue

NCT04793607 | Unknown

• 1 other identifier: NHCT0161
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Malignant Pleural Effusions (MPE) are a common problem with around 40,000 new cases in the UK each year. The presence of an MPE suggests a poor prognosis of on average of 3-12 months. It is therefore vital that the investigators consider how respiratory and palliative care physicians can best support patients with MPEs to have the best quality of life possible. Breathlessness is the most common presenting symptom of an MPE and so impact on this has previously been studied . Cancer-related fatigue is very common with evidence suggesting around 40% of patients experience fatigue at diagnosis and up to 90% during anti-cancer treatment such as radiotherapy or chemotherapy. Review of the literature suggests that whether interventions to manage MPEs can improve patient fatigue has not previously been studied. The aim of this study is to assess if interventions for MPEs could potentially improve patient fatigue as this information will be valuable for both patients and referring health-care professionals when making the decision of whether to have a procedure or not and build on the current evidence base around management of MPEs. The study will be part of a Masters in Clinical Research and will be within a single trust. It will be a pilot study for a potentially larger multi-center study. With this in mind, aspects of how the study runs and notes on how it could be improved upon will be carefully recorded.

Conditions

Malignant Pleural Effusion

Keywords

pleural effusion; malignancy

Outcome Measures

Primary Outcomes (1)

• Fatigue levels as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) form. Minimum score is zero and maximum score is 52. Higher scores mean high levels of fatigue.

  At the time of their pleural procedures, recruited participants will fill in, with the help of the investigator, the FACIT-F form to determine their current level of fatigue. The participant will then be contacted to record their fatigue levels using the same questionnaire at 7, 14 and 30 days

  Up to 1 month

Interventions

Pleural procedures OTHER

Any pleural procedure that removes fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient above the age of 18 with a presumed malignant pleural effusion referred to the Northumbria specialist pleural service

You may qualify if:

• Patients referred to the Northumbria specialist pleural service to have an intervention for a malignant pleural effusion
• Age 18+ years

You may not qualify if:

• ° Patients who lack capacity to give consent.

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead
• Rocket Medical plc: collaborator

Study Sites (1)

Northumbria HealthCare NHS Foundation Trust

Newcastle, United Kingdom

RECRUITING

Related Publications (4)

• 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: 30272503 RESULT

• Hofman M, Ryan JL, Figueroa-Moseley CD, Jean-Pierre P, Morrow GR. Cancer-related fatigue: the scale of the problem. Oncologist. 2007;12 Suppl 1:4-10. doi: 10.1634/theoncologist.12-S1-4.

  PMID: 17573451 RESULT

• Minton O, Stone P. A systematic review of the scales used for the measurement of cancer-related fatigue (CRF). Ann Oncol. 2009 Jan;20(1):17-25. doi: 10.1093/annonc/mdn537. Epub 2008 Aug 4.

  PMID: 18678767 RESULT

• Prue G, Rankin J, Allen J, Gracey J, Cramp F. Cancer-related fatigue: A critical appraisal. Eur J Cancer. 2006 May;42(7):846-63. doi: 10.1016/j.ejca.2005.11.026. Epub 2006 Feb 7.

  PMID: 16460928 RESULT

MeSH Terms

Conditions

Pleural Effusion, Malignant; Pleural Effusion; Neoplasms

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Donna Wakefield, MBBS

  Northumbria Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avinash Aujayeb, MBBS

CONTACT

07703343329; avinash.aujayeb@nhct.nhs.uk

Donna Wakefield, MBBS

CONTACT

donna.wakefield1@nhs.net

Study Design

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

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: March 11, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)