Interventions for Malignant Pleural Effusions Impact on Fatigue

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.

Both inpatients and outpatients are referred to the pleural service. They are assessed in clinic and a decision made on the most appropriate treatment of the Malignant Pleural Effusion. The study will have no impact on which intervention is chosen. Once the decision is made the patient will be asked by the doctor in clinic if they are potentially interested in being involved in the study. If they are interested then they will be seen by the researcher who will take them through the Participant Information Sheet (PIS) and give them the opportunity to ask questions. If they agree then they will be invited to provide written informed consent.

The researcher is a consultant with training in assessing patients capacity and so it will be ensured that all participants are able to give valid written consent. Those unable to give consent will be excluded from the study. Reasonable adjustments will be made to cater for patients with hearing or visual impairment.

It will be made clear that the decision to take part in the study or not will have no impact on the patient's care. It will also be explained that the patient is free to withdraw from the study at any time and under no obligation to give reason for doing so.

It will be made clear to the potential participants that taking part in the study will have no impact on their treatment. There will be no direct benefit to the participant other than for altruistic reasons such as knowing that their involvement is contributing to the research base which may improve care for patients of the future.

This study is fairly low burden as it is a short questionnaire about fatigue levels (13 questions) and permission to gather further data about the patient (age, sex, disease site, performance status, last Hb result- see list above). The participant will give permission for the researcher to telephone them to repeat the questions after 7,14 \& 30 days. The question takes less than 5 minutes to answer and so is of low burden.

There is no direct risk to staff or patient.

It is possible that the patient becomes more unwell or dies during the 30-day study period. It may therefore be upsetting to the patient or family to be contacted if this was the case. To try and avoid this then the patient's electronic records will be consulted prior to making contact via telephone. However, it may occasionally be possible that the death is not yet recorded in the electronic records and so all calls will be handled in a sensitive manner. The researcher is a Palliative Medicine consultant with advanced communication skills training and many years experience of having discussions with patients approaching the end of life as well as bereaved families.