- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495530
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?
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, NW1 2BU
- University College London Hospitals Nhs Foundation Trust
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital NHS Foundation Trust
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London, United Kingdom, HA1 3UJ
- St Mark's Hospital
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London, United Kingdom, SW17 0QT
- St George's NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient
Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition
|
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
|
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
Time Frame: Through completion of study; expected 1 year
|
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
Time Frame: Through completion of study; expected 1 year
|
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
Collaborators
Investigators
- Principal Investigator: Clare Shaw, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR 5217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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