Interventions for Malignant Pleural Effusions Impact on Fatigue Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Detailed Description
The aim of the study is to assess if the interventions for MPEs have an impact on fatigue levels. There are multiple different possible interventions to treat a pleural effusion and the most appropriate is decided on a case-by-case basis after discussion between the patient and doctor. The study will have no impact on which intervention the participant receives.
Fatigue is extreme tiredness unrelieved by rest. It is how the patient feels and so there is no specific test for it. However there are a number of tools that help record a patients self-reported fatigue levels and how this changes over time. The FACIT-fatigue tool has been studied in patients with cancer-related fatigue and has the strongest evidence base and validation in this patient group. It involves the patient answering 13 questions related to fatigue and its impact on their activities of daily living.
There are multiple contributing factors associated with malignancy-related fatigue and so consent will be gained to gather data on potential confounding factors. This will include
- Patient age
- Sex
- Patient diagnosis (site/type of cancer and whether metastatic)
- Comorbidities (esp. lung disease)
- Time since cancer diagnosis
- Time since last anti-cancer therapy/if currently having chemotherapy or radiotherapy
- BEDS&GADS score for anxiety/depression
- Patient Outcome Score (POS) indicating whether high symptom burden
- Size of pleural effusion & if unilateral/bilateral
- Performance status
- Blood markers- Haemoglobin level & Creatinine
The study will involve a single pleural service in Northumbria Healthcare NHS Foundation Trust.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients referred to the Northumbria specialist pleural service to have an intervention for a malignant pleural effusion
- •Age 18+ years
Exclusion Criteria
- •° Patients who lack capacity to give consent.
Outcomes
Primary Outcomes
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.
Time Frame: Up to 1 month
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
Secondary Outcomes
No secondary outcomes reported