Information Needs Around Parenteral nUTrition in Cancer

Cancer Clinical Trial

— INPUT  

Official title:

What Information do Patients and Carers Need to Make an Informed Decision to Commence and Discontinue Parenteral Nutrition, in Advanced Cancer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495530
• Other study ID #: CCR 5217
• Status: Completed
• Start date: January 19, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• End Stage Cancer
• Malignancy
• Malignant Neoplasm
• Neoplasms
• Terminal Cancer
• Tumor

Intervention

Other:
• Non-interventional study
semi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	London
United Kingdom	St George's NHS Foundation Trust	London
United Kingdom	St Mark's Hospital	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (5)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	London North West Healthcare NHS Trust, St George's University Hospitals NHS Foundation Trust, University College London Hospitals, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The type of information that patients and carers need to make an informed decision to commence or discontinue parenteral nutrition	This exploratory study will provide insight into the information that patients with advanced cancer, and their carers need to make an informed decision to commence and discontinue parenteral nutrition	Through completion of study; expected 1 year
Secondary	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	Patients and carers will provide insight into how they would like to receive information regarding parenteral nutrition from the clinical team. This may be through verbal or written communication.	Through completion of study; expected 1 year