CancerCASCADENCT06117592
The CASCADE Project
An observational study of Cancer, run by The Christie NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Education, training and assessment intervention
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 29 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with suspected neutropenic sepsis or MSCC
Who may be able to join
- All patient KPI's of interest that occur in the study time frame will be collected.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Co-design of Acute Oncology Standardised Assessment Documents and Their Evaluation
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.
Read more
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.
- Conditions
- Cancer
- Being tested
- Education, training and assessment intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, training and assessment interventionOther
Staff competence assessment documents for acute oncology knowledge and skills
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | Retrospective data collection for pre-education intervention period: 1st April 2023- 1st June 2023 Receives: Other: Education, training and assessment intervention | |
| Post-Intervention | Retrospective data collection for post-education intervention period: 1st October 2023- 31st December 2023 Receives: Other: Education, training and assessment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st April 2023- 31st December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion29 Mar 2024 (estimated)
- Study completion29 Mar 2024 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare Griffin, PhD, Study director, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117592
- Sponsor's protocol ID
- cftsp227
- Acronym
- CASCADE
- Status last verified
- Feb 2024
- First submitted
- 31 Oct 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design of Acute Oncology Standardised Assessment Documents and Their Evaluation
- ClinicalTrials.gov ID
- NCT06117592
- Acronym / sponsor ID
- CASCADE / cftsp227
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | – | Other: Education, training and assessment interventionRetrospective data collection for pre-education intervention period: 1st April 2023- 1st June 2023 |
| Post-Intervention | – | Other: Education, training and assessment interventionRetrospective data collection for post-education intervention period: 1st October 2023- 31st December 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with suspected neutropenic sepsis or MSCC
Key inclusion criteria (1 listed)
- All patient KPI's of interest that occur in the study time frame will be collected.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Education, training and assessment interventionStaff competence assessment documents for acute oncology knowledge and skills | Other | Post-Intervention, Pre-Intervention |
Primary outcome
Acute Oncology Key Performance Indicators (KPIs)
Time frame: 1st April 2023- 31st December 2023
These are routinely collected metrics by acute oncology teams for patients presenting with suspected neutropenic sepsis or metastatic spinal cord compression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- 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 Griffin, PhD study director
The Christie NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The Christie NHS Foundation Trust.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verna TC Lavender, PhD (07773664761, Verna.Lavender@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Oncology Key Performance Indicators (KPIs) (time frame: 1st April 2023- 31st December 2023). 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 21 Feb 2024.