NCT06117592

Brief Summary

People with cancer, treated for cancer, or have been recently treated for cancer are at a higher risk of becoming rapidly unwell. This is referred to as an oncological emergency and can be life-threatening. The investigators want to see if a new, standardised assessment of acute oncology knowledge and skills of all health care staff (The Acute Oncology Passport) following education and training, has an effect on the diagnosis and treatment of two relatively-common oncological emergencies: sepsis and MSCC? Sepsis is blood poisoning, which causes serious injuries if it is not diagnosed and treated as an emergency and may result in death if not treated quickly enough. MSCC is metastatic spinal cord compression, where the cancer presses on the spinal cord and can cause permanent paralysis. The investigators have chosen these two conditions, not only because of how serious and relatively common they are for people living with cancer, but also because all NHS Trusts in the UK routinely collect and report standardised data about patients who are admitted with suspected sepsis or MSCC. The investigators plan to compare data that is routinely collected about the diagnosis and treatment of patients with suspected sepsis and MSCC before and after education, training and assessment of staff about acute oncology. The investigators will conduct 'secondary analysis' on the data, as it was originally collected for another purpose. The routinely data collected at five hospital Trusts across the UK from 1st April 2023 to 30th June 2023 and 1st October to 31st December 2023 will be included in this study. This research is part of a larger UK-wide project, funded until March 2024 by NHS England Workforce, Training and Education Directorate. If acute oncology education, training and assessment of staff is shown to make a difference to patient diagnosis and treatment, the Acute Oncology Passports will be rolled-out nationally.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

28 days

First QC Date

October 31, 2023

Last Update Submit

February 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute Oncology Key Performance Indicators (KPIs)

    These are routinely collected metrics by acute oncology teams for patients presenting with suspected neutropenic sepsis or metastatic spinal cord compression.

    1st April 2023- 31st December 2023

Study Arms (2)

Pre-Intervention

Retrospective data collection for pre-education intervention period: 1st April 2023- 1st June 2023

Other: Education, training and assessment intervention

Post-Intervention

Retrospective data collection for post-education intervention period: 1st October 2023- 31st December 2023

Other: Education, training and assessment intervention

Interventions

Staff competence assessment documents for acute oncology knowledge and skills

Post-InterventionPre-Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients with suspected neutropenic sepsis or MSCC

You may qualify if:

  • All patient KPI's of interest that occur in the study time frame will be collected.

You may not qualify if:

  • KPI data collected from people under the age of 18 KPI data other than items stated in this application, i.e. data that is not reporting neutropenic sepsis nor MSCC outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Clare Griffin, PhD

    The Christie NHS Foundation Trust

    STUDY DIRECTOR

Central Study Contacts

Verna TC Lavender, PhD

CONTACT

Gina R Madera, BSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

March 1, 2024

Primary Completion

March 29, 2024

Study Completion

March 29, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share