Information Needs Around Parenteral nUTrition in Cancer (INPUT)

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Cancer; Tumor; Malignant Neoplasm; End Stage Cancer; Malignancy; Terminal Cancer
• Intervention / Treatment: Other: Non-interventional study

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital NHS Foundation Trust
  • London, United Kingdom, HA1 3UJ
    • St Mark's Hospital
  • London, United Kingdom, SW17 0QT
    • St George's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition	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
Carer; Carers will be those caring for a patient with advanced cancer who is considering commencing or discontinuing parenteral nutrition, or already receiving parenteral nutrition. Carers will also be recruited if they previously cared for a person with advanced cancer receiving parenteral nutrition in the last 12 months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: University College London Hospitals; University of Southampton; St George's University Hospitals NHS Foundation Trust; London North West Healthcare NHS Trust
• Investigators: Principal Investigator: Clare Shaw, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CCR 5217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No