Clinical trial NCT04495530: Information Needs Around Parenteral nUTrition in Cancer
Official title: What Information do Patients and Carers Need to Make an Informed Decision to Commence and Discontinue Parenteral Nutrition, in Advanced Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
End Stage Cancer
Terminal Cancer
Neoplasms
Tumor
Malignancy
Malignant Neoplasm
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: St George's University Hospitals NHS Foundation Trust
name: University College London Hospitals
name: University of Southampton
name: London North West Healthcare NHS Trust
First posted: 2020-08-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the inpatient and outpatient setting (intestinal failure clinic). Carers may be recruited from participating hospitals if they are caring for a patient under the care of that centre. Carers will also be recruited via social media, and online support networks.

Brief summary: This study will explore the information needs of patient's with advanced cancer, and their carers, when making a decision to commence or discontinue parenteral nutrition. Interviews will be conducted with both patients with advanced cancer, and their carers to determine the information they need to make a shared decision with the healthcare team.

Detailed description: Parenteral nutrition (PN) is a type of nutritional liquid that is given directly into a vein, and is usually given when a person does not have a working gut. This type of nutrition is managed by a team of healthcare professionals and requires regular monitoring, such as bloods tests, to allow the team to provide the right balance of nutrients to the individual patient. This is an important decision, and the benefits, risks and consequences of having this type of nutrition should be fully explained to the patient and carer, to make sure they can make an informed decision. The aim of this study is to find out what information both patients and carers feel they need to be able to make a decision to start, and a later date stop, parenteral nutrition, with a diagnosis of advanced (incurable) cancer.

It is not clear if patients and carers get all the information they need before making this decision, and often the decision is made by a doctor and other healthcare professionals. However, patients and carers have a right to make decisions about their care. We will therefore interview patients and carers who have experience of making this decision, or in the process of making this decision, to find out what information is important to them. Our aim is to use the results from this research to improve the experience that patients and carers have in the future.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and over
* Fluent English speaker
* Is aware of diagnosis of advanced cancer
* Patient considering starting PN, is currently receiving PN or has previously received PN OR
* Carer of a patient considering, receiving or who has received PN
* NHS patient
* Assessed as having capacity to give consent and participate
* Current patient at one of the recruiting hospital sites

Exclusion Criteria:

* Private patients

Primary outcomes:
measure: The type of information that patients and carers need to make an informed decision to commence or discontinue parenteral nutrition
timeFrame: Through completion of study; expected 1 year
Secondary outcomes:
measure: How healthcare professionals should deliver information to patients and carers in order for them to make an informed decision to commence or discontinue parenteral nutrition
timeFrame: Through completion of study; expected 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mark's Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Clare Shaw
role: PRINCIPAL_INVESTIGATOR
References: