CancerINPUTNCT04495530
Information Needs Around Parenteral nUTrition in Cancer
An observational study of Cancer and End Stage Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, End Stage Cancer, Terminal Cancer
- What is being tested?
- Non-interventional study
- How many people
- 12 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 19 Jan 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Private patients
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
St Mark's Hospital
London, HA1 3UJ
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
St George's NHS Foundation Trust
London, SW17 0QT
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, End Stage Cancer, Terminal Cancer, Neoplasms, Tumor, Malignancy
- Being tested
- Non-interventional study
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
semi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition Receives: Other: Non-interventional study | |
| 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 Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through completion of study; expected 1 year
Secondary outcomes (1)
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.
Measured: Through completion of study; expected 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start19 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, University College London Hospitals, University of Southampton, London North West Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Clare Shaw, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495530
- Sponsor's protocol ID
- CCR 5217
- Acronym
- INPUT
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Information do Patients and Carers Need to Make an Informed Decision to Commence and Discontinue Parenteral Nutrition, in Advanced Cancer?
- ClinicalTrials.gov ID
- NCT04495530
- Acronym / sponsor ID
- INPUT / CCR 5217
- Conditions
- Cancer, End Stage Cancer, Terminal Cancer, Neoplasms, Tumor, Malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, University College London Hospitals, University of Southampton, London North West Healthcare NHS Trust
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Non-interventional studyPatients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition |
| Carer | – | Other: Non-interventional studyCarers 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Private patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studysemi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions | Other | Carer, Patient |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Shaw principal investigator
Royal Marsden NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and End Stage Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.