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Trial registered on ANZCTR


Registration number
ACTRN12624000396527
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Date results information initially provided
3/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of COVID-19 on colorectal cancer in regional Northern Queensland and changes to treatment related to distance to care
Scientific title
The impact of COVID-19 on colorectal cancer in regional Northern Queensland and changes to treatment related to distance to care
Secondary ID [1] 311312 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 332563 0
COVID-19
 332564 0
Condition category
Condition code
Surgery 329263 329263 0 0
Other surgery
Infection 329758 329758 0 0
Other infectious diseases
Cancer 329759 329759 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Respiratory 329760 329760 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients being treated with colorectal cancer will be assessed during the COVID 19 pandemic to assess if there has been increased emergency presentations and other changes to their treatment profile

There will be no direct patient contact, a retrospective review of patient charts will be undertaken
Observation would be for that current time perioud between March 2019 - July 2022
Intervention code [1] 327761 0
Diagnosis / Prognosis
Comparator / control treatment
Those patients treated during COVID will be compared to those treated prior to covid
March 2019-July 2019 (pre-COVID period) and March 2020-July 2022 (COVID period)
Data collection occurred between 17/8/22 after ethics approval and 31/1/2023 when data collection complete
Control group
Historical

Outcomes
Primary outcome [1] 337084 0
primary aim to review number of emergency presentations with more advanced disease in terms of colorectal cancer during the COVID 19 pandemic compared to the Pre-COVID time period.
Timepoint [1] 337084 0
COVID March 2020-July 2022.
Pre covid
March 2019-July 2019) March 2020-July 2022
Secondary outcome [1] 430610 0
• Compare complication rates
Timepoint [1] 430610 0
pre-covid March 2019-July 2019
during covid March 2020-July 2022
Secondary outcome [2] 432259 0
Assessing referral times during covid-19 and prior to the pandeminc lead to assess time between GP referral and definitive management of CRC
Timepoint [2] 432259 0
March 2019-July 2019 (pre-COVID period) and March 2020-July 2022 (COVID period)
Secondary outcome [3] 432260 0
Distance to care that patients had to travel from home to the hospital being managed definitively in
Timepoint [3] 432260 0

March 2019-July 2022
Secondary outcome [4] 432261 0
Open or laparoscopic resection
Timepoint [4] 432261 0
March 2019 - July 2022
Secondary outcome [5] 432262 0
Stage of cancer at time of operation or diagnosis if already metastatic
Timepoint [5] 432262 0
March 2019 - July 2022
Secondary outcome [6] 433334 0
length of stay
Timepoint [6] 433334 0
march 2019-july 2022

Eligibility
Key inclusion criteria
Inclusion criteria: all patients that were diagnosed or treated for colorectal cancer during the time periods being analysed and definitively managed at the Townsville University Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: patients treated for benign pathology and for non colonic/rectal adenocarcinoma i.e. anal scc

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
All statistics were examined using SPSS statistics for Windows; SPSS Statistics for Windows, Version 27.0 Armonk, NY: IBM Corp. and RStudio Team (2015) version 0.99.486, Integrated Development for R. RStudio, Inc., Boston, MA. A p value of <0.05 was considered to be statistically significant; Pearons Chi Squared or Fishers Exact Test were used depending upon the sample size in each group. For assessment of continuous data Mann Whitney u was used, in this study this was the days to referral and being managed as well as the distance to care

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2022
Date of last participant enrolment
Anticipated
Actual
31/01/2023
Date of last data collection
Anticipated
Actual
31/01/2023
Sample size
Target
200
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26011 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 41858 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 315566 0
Self funded/Unfunded
Name [1] 315566 0
Country [1] 315566 0
Primary sponsor type
Individual
Name
Richard Maguire
Address
48 121-125 Surf Parade Broadbeach
Country
Australia
Secondary sponsor category [1] 317657 0
None
Name [1] 317657 0
Address [1] 317657 0
48 121-125 Surf Parade Broadbeach
Country [1] 317657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314465 0
Townsville Hospital and Health Service Audit, Quality and Innovation Review (AQUIRE) Panel
Ethics committee address [1] 314465 0
100 Angus Smith Drive Douglas 4814 QLD
Ethics committee country [1] 314465 0
Australia
Date submitted for ethics approval [1] 314465 0
25/07/2022
Approval date [1] 314465 0
17/08/2022
Ethics approval number [1] 314465 0
THHSAQUIRE1492

Summary
Brief summary
The COVID-19 pandemic has created challenges in the diagnosis and management of colorectal cancer (CRC). It was proposed in regional North Queensland the distance to services could further impact cancer outcomes, leading to delayed diagnosis. We compared the outcomes of patients prior and during the pandemic; with a focus on whether patients were presenting in the emergency setting with more advanced disease (i.e.T4 tumours, locally advanced cancers or stage III/IV CRC). The distance to treatment was also analysed to see if any impact occurred to the management of patients with colorectal cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131674 0
Dr Richard Maguire
Address 131674 0
100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
Country 131674 0
Australia
Phone 131674 0
+61 0438634824
Fax 131674 0
Email 131674 0
[email protected]
Contact person for public queries
Name 131675 0
Richard Maguire
Address 131675 0
100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
Country 131675 0
Australia
Phone 131675 0
+61 0438634824
Fax 131675 0
Email 131675 0
[email protected]
Contact person for scientific queries
Name 131676 0
Richard Maguire
Address 131676 0
100 Angus Smith Drive, Douglas 4215 QLD Townsville University Hospital
Country 131676 0
Australia
Phone 131676 0
+61 0438634824
Fax 131676 0
Email 131676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data for the purpose of research not to be distributed outside the health service


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21370Study protocol  [email protected] see upload 387154-(Uploaded-12-01-2024-12-16-52)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.