NCT04495530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

July 21, 2020

Last Update Submit

July 14, 2022

Conditions

CancerEnd Stage CancerTerminal CancerNeoplasmsTumorMalignancyMalignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 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

    Through completion of study; expected 1 year

Study Arms (2)

Patient

Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition

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

Other: Non-interventional study

Interventions

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

CarerPatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Private patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Mark's Hospital

London, HA1 3UJ, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

St George's NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Clare Shaw

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

August 3, 2020

Study Start

January 19, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)