NCT04519632

Brief Summary

To describe the the barriers and facilitators experienced by carers and healthcare professionals when managing medicines for pain relief for infants, children, and young people approaching the end of life in out of hospital settings.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

June 27, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

June 27, 2019

Last Update Submit

August 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Qualitative data obtained from semi-structured interviews

    Barriers and facilitators to managing pain in infants, children, and young people at end of life as reported by parents, caregivers, healthcare professionals and children and young people.

    Baseline

Study Arms (3)

Parents

Qualitative interviews

Other: Qualitative study

Healthcare Professionals

Qualitative interviews

Other: Qualitative study

Children

Children and young people aged 6-18 years, Qualitative interviews

Other: Qualitative study

Interventions

Qualitative interviews

ChildrenHealthcare ProfessionalsParents

Eligibility Criteria

Age6 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents and carers of infants, children and young people at the end-of-life being cared for in the community, the healthcare professionals supporting them, and the children and young people who receive this care

You may qualify if:

  • Carers of infants, children, and young people up to 18 years being cared for outside hospital at the end of life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool and/or who have a symptom management plan (including pain management) written by a specialist palliative care team.
  • Self-reported full or partial responsibility for managing the patient's medicines, in particular having to select PRN (pro re nata or 'taken as needed') for pain and being responsible for the clinical decision making and the physical process of administering medicines.
  • Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children at end-of-life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool) outside hospital, some of whom may be caring for the families taking part.
  • Children and young people aged 6-18 years who are being cared for outside hospital at the end of life defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool).

You may not qualify if:

  • Carers judged by consultants or nurses to lack capacity to consent.
  • Carers judged by nurses to be 'struggling' too much (however, these carers will still be able to approach the researcher directly if they wish to take part as posters will be used to advertise the study).
  • CYP judged by carers or nurses to lack capacity to take part in an interview, who are too unwell or those who might find it too distressing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton

Southampton, SO17 1BJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Christina Liossi, PhD

    University of Southampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Holley, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 27, 2019

First Posted

August 19, 2020

Study Start

July 15, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations