COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000781943
Ethics application status
Approved
Date submitted
1/05/2020
Date registered
3/08/2020
Date last updated
3/08/2020
Date data sharing statement initially provided
3/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COSMIC Study - Colorectal cancer Outcomes in people with Severe Mental Illness
Scientific title
What is the impact of the National Bowel Cancer Screening Program on colorectal cancer
outcomes for people over the age of 50 with severe mental illness?
Secondary ID [1] 300629 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COSMIC Study (Colorectal Outcomes in people with Severe Mental Illness)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Mental Illness 316399 0
Colorectal Cancer 316400 0
Mental Health 317464 0
Condition category
Condition code
Mental Health 314772 314772 0 0
Schizophrenia
Cancer 314773 314773 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Mental Health 315563 315563 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are assessing the impact of the National Bowel Cancer Screening Program (NBCSP) by comparing participation rates of people with and without Severe Mental Illness (SMI) and looking at health outcomes. We will be using data collected from Aug 2006 - latest available.
We are linking data using Commonwealth data (NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database & the National Death Index) to compare bowel cancer screening participation in people with SMI to those from the general population. We will additionally link these to the NSW cancer registry and hospital data to examine care pathways from diagnosis through treatment and end-of-life care.

We will also conduct a consultation with people with experience of SMI and Colorectal cancer and people with SMI in peer support roles who can provide their perspective on the barriers faced by people with SMI to gaining timely screening, diagnosis and optimal care.
These participants will be recruited from New South Wales consumer organisations and organisations with a strong focus on provision of peer support and advocacy. We will use a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5). We will use this qualitative arm of the study to further develop our understanding of the quantitative findings. The consultation will also develop ideas on how to improve access to care.
Intervention code [1] 317033 0
Early Detection / Screening
Comparator / control treatment
AIHW will randomly select a sample of people on the Medicare Enrolments File selecting 1 in 4 people from the entire population aged 50-74 years at 01/01/2006 or who turn 50 after this date or become Medicare eligible (and were 50 years or over) after this date. This group will consist of people who have not been dispensed a prescription for one of the specified PBS medicines between 1/7/2002 to latest available. We will also use control data collected from the beginning of the National Bowel Cancer Screening Programme: Aug 2006 to the lastest available.
Control group
Historical

Outcomes
Primary outcome [1] 323406 0
Participation rates in the National Bowel Cancer Screening Program assessed using data from the NBCSP.
Timepoint [1] 323406 0
Person-years will be calculated from entry into the study (2006) (the date of commencement of the NBCSP) or from the year that people become eligible for screening (i.e. age 50), whichever occurs later.. This is a retrospective cohort study, so all of the outcomes have already occurred and were recorded in the administrative data. This will be assessed when we receive the data.
Primary outcome [2] 323831 0
Colonoscopy rates assessed using data from the NBCSP
Timepoint [2] 323831 0
Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until colonoscopy. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Primary outcome [3] 323832 0
Cancer diagnosis using data from the Australian Cancer Database
Timepoint [3] 323832 0
Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until cancer diagnosis. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [1] 381844 0
Amongst the NSW cohort of those diagnosed with colorectal cancer (CRC) we will ascertain stage at initial presentation using data provided by the NSW Cancer Registry. They define four stage categories: localised (Localised to tissue of origin); regional spread (spread to adjacent organs and/or regional lymph nodes); distant (distant metastases); and unknown.
Timepoint [1] 381844 0
Diagnosis date may occur anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [2] 383005 0
Number of hospital admissions in each year after diagnosis with colorectal cancer in NSW until death or the end of the study. Number of hospital admissions per year will be calculated using the separations data from the NSW Admitted Patient Data Collection
Timepoint [2] 383005 0
Diagnosis of CRC may occur anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever is latest. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [3] 383006 0
Proportion of those diagnosed with colorectal cancer in NSW who have surgical resection of their cancer. These data will be ascertained using procedure codes from the NSW Admitted Patient Data Collection.
Timepoint [3] 383006 0
Surgery for cancer may occur anytime from entry into the study (2006, the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [4] 383007 0
Proportion of those with and without SMI who required a hemicolectomy.
Timepoint [4] 383007 0
Hemicolectomy for cancer may occur anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [5] 383008 0
Proportion of those with a diagnosis of colorectal cancer in NSW who received any chemotherapy, when indicated, within six months of diagnosis of their cancer. This information will be ascertained through linked PBS records for the participants.,
Timepoint [5] 383008 0
Chemotherapy for cancer may occur anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [6] 383335 0
Proportion of those diagnosed with colorectal cancer in NSW who received any radiotherapy from date of diagnosis through to death or end of study (whichever occurs first).
Timepoint [6] 383335 0
Radiotherapy for cancer may occur anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [7] 383894 0
Time from diagnosis to date of first onset of chemotherapy treatment using data from the NSW Admitted Patient Data Collection and PBS records.
Timepoint [7] 383894 0
The date of first onset of chemotherapy treatment may occur anytime from entry into the study and diagnosis with CRC (from 2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50)), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [8] 383895 0
Time from diagnosis with colorectal cancer in NSW to first delivery of radiotherapy.. We will ascertain this using date of diagnosis from the NSW Cancer Registry and data of first radiotherapy treatment ascertained from the NSW Admitted Patient Data Collection.
Timepoint [8] 383895 0
First radiotherapy treatment may occur anytime from cancer diagnosis (after entry into the study - (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50)), through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [9] 383896 0
Number of chemotherapy treatments administered, when indicated, after diagnosis of CRC in NSW in six month periods from diagnosis until the end of the study using admission diagnosis data from the NSW Admitted Patient Data Collection and PBS records.
Timepoint [9] 383896 0
Anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), at annual intervals through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [10] 383897 0
Number of radiotherapy treatments after diagnosis of CRC in NSW in six month periods from diagnosis until the end of the study using data from the NSW Admitted Patient Data Collection.
Timepoint [10] 383897 0
Anytime from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), at annual intervals through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [11] 383898 0
Time from first colorectal cancer surgery until first dose of chemotherapy, when indicated, using data from the NSW Admitted Patient Data Collection and data from the PBS.
Timepoint [11] 383898 0
First onset of chemotherapy delivery may occur anytime from surgery through to the end of the latest available data. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [12] 383899 0
Mortality using data from the National Death Index.
Timepoint [12] 383899 0
Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), until death. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.
Secondary outcome [13] 383900 0
Qualitative data on the views & experiences of people with experience of mental illness and bowel cancer (directly or in support roles) as a composite outcome using a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer, as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles. Participants will be asked about their experience with cancer screening, diagnosis and being in receipt of care. Barriers (for example delays in returning kits) and enablers (for example having a support person) to getting timely and optimal treatment will be discussed, as well as how these barriers may be overcome or enablers enhanced. A semi structured group interview schedule will be used to facilitate discussion at the focus group. No tests or structured outcome measures will be included.
Timepoint [13] 383900 0
One-off focus group conducted 2021-2022

Eligibility
Key inclusion criteria
National cohort
People with SMI: We will define people as having SMI using PBS data. Those who have been dispensed at least two prescriptions for authority-only medications used specifically for SMI since 01/07/2002 (the commencement of the PBS dataset). We will include only people aged 50-74 years at 01/01/2006 or who turn 50 after this date or become Medicare eligible (and were 50-74 years) after this date.
NSW cohort
All men and women aged 50-74 years, registered in the NSW Cancer Registry with a new diagnosis of cancer of the colon or rectum diagnosed after 01/01/2006 to the latest available.
Comparator group
The AIHW will randomly select a sample of people on the Medicare Enrolments File selecting 1 in 4 people from the entire population aged 50-74 years at 01/01/2006 or who turn 50 after this date or become Medicare eligible (and were 50 years or over) after this date. This group will consist of people who have not been dispensed a prescription for one of the specified PBS medicines between 1/7/2002 to latest available.
Focus group
The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5).
Minimum age
50 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People under the age of 50 and over the age of 74 at the time of their colonoscopy.
People who have not been diagnosed with SMI ie: who have not been dispensed at least two prescriptions for authority-only medications used specifically for SMI since 01/07/2002.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis
Incidence analyses:

We will use Poisson regression to calculate incidence rates and rate ratios (IRRs) or Cox regression to calculate hazard ratios, as appropriate, for each outcome (FOBT, colonoscopy, cancer diagnosis, surgery, chemo/radiotherapy and mortality), comparing those with and without SMI and the effects of the NBCSP on these outcomes. Person-years will be calculated from 2006 (the year of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later. If an individual becomes eligible for screening before they are dispensed a medicine for an SMI then the years prior to the first prescription will be considered ‘unexposed’. For NSW residents we will also assess for cancer stage at diagnosis.
We will undertake sensitivity analyses of whether NBCSP participation by people with SMI reduces any disparity in mortality or cancer care outcomes (e.g. colonoscopy Australia-wide following a +ve FOBT a in the NBCSP and surgery in NSW) compared to those 50-74 years who participated in the program (Australia-wide), or everyone who was 50-74 years old (NSW).
Adjusting for confounders: The models using only the national data will be adjusted for age, area-level socio-economic status and state.
We will also explore the possibility of adjusting for concessional status (holding a health care card or similar to receive further subsidisation on costs of medicines or health services) as a further marker of socio-economic status. Data on the number and type of medical consultations for each person during the study period, (from Medicare) will be considered as mediators in the model. For analyses using NSW data we will also adjust for comorbidities by constructing a Charlson comorbidity score using principal and additional diagnosis codes from hospital morbidity data.

Other quantitative analyses:

We will use multiple regression for continuous data and logistic regression for dichotomous data, adjusting for the same variables as above to measure differences in the number of secondary outcomes such as number of chemo-/ radio-therapy sessions between those with, & without, SMI. This will be done at annual intervals from entry to the study to the end of the latest available data.

Qualitative analyses:

NVivo software will be used to analyse the data from the focus group using a general inductive approach to data analysis – this includes identifying responses to our research questions about enablers and barriers, as well as identifying emerging themes that will be integrated into a final presentation of the thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305052 0
Government body
Name [1] 305052 0
Cancer Australia
Address [1] 305052 0
Level 14, 300 Elizabeth St, Surry Hills NSW 2010
Locked Bag 3, Strawberry Hills NSW 2012

canceraustralia.gov.au
Country [1] 305052 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Medicine
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road,
Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 305417 0
None
Name [1] 305417 0
Address [1] 305417 0
Country [1] 305417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305440 0
Australian Institute of Health & Welfare (AIHW)
Ethics committee address [1] 305440 0
1 Thynne St, Bruce ACT. 2617

GPO Box 570 Canberra ACT.2061
Ethics committee country [1] 305440 0
Australia
Date submitted for ethics approval [1] 305440 0
30/10/2019
Approval date [1] 305440 0
10/12/2019
Ethics approval number [1] 305440 0
EO2019-5-1108
Ethics committee name [2] 305855 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 305855 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [2] 305855 0
Australia
Date submitted for ethics approval [2] 305855 0
13/03/2019
Approval date [2] 305855 0
30/04/2019
Ethics approval number [2] 305855 0
2019000260
Ethics committee name [3] 305857 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [3] 305857 0
Office of Research Services Private Bag 1
Hobart TAS 7001

301 Sandy Bay Road, Sandy Bay TAS 7005
Ethics committee country [3] 305857 0
Australia
Date submitted for ethics approval [3] 305857 0
30/01/2020
Approval date [3] 305857 0
19/02/2020
Ethics approval number [3] 305857 0
H0018672
Ethics committee name [4] 305858 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [4] 305858 0
PO Box 8172 Perth Business Centre
Perth WA 6849 Australia
Ethics committee country [4] 305858 0
Australia
Date submitted for ethics approval [4] 305858 0
19/03/2020
Approval date [4] 305858 0
16/04/2020
Ethics approval number [4] 305858 0
RGS0000003836
Ethics committee name [5] 306086 0
NSW Population and Health Service Research Ethics Committee
Ethics committee address [5] 306086 0
Cancer Institute NSW
Level 9, 8 Central Avenue,
Australian Technology Park,
Eveleigh NSW 2015

PO Box 41, Alexandria, NSW 1435
Ethics committee country [5] 306086 0
Australia
Date submitted for ethics approval [5] 306086 0
04/05/2020
Approval date [5] 306086 0
21/05/2020
Ethics approval number [5] 306086 0
2020/ETH00414

Summary
Brief summary
This study will examine the impact of the National Bowel Cancer Screening Program (NBCSP) on colorectal cancer outcomes for people over the age of 50 with severe mental illness.

Who is it for?
This retrospective study will be looking at data on people aged 50-74 and who have participated in the NBCSP, with or without severe mental illness. We will also be consulting with people with severe mental illness and their carers on barriers to screening and optimal care.

Study details
This is a data linkage study of multiple Commonwealth datasets: NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database and the National Death Index. Data linkage with NSW Cancer registry and hospital data will also be used.

This research project is directly focused on identifying where access and/or treatment disparities exist along the colorectal cancer care pathway for people with severe mental illness in order to improve access and service utilisation, and ultimately to improve cancer survival for this very disadvantaged group.
Trial website
Trial related presentations / publications
Public notes
The Cancer Registry data custodians from South Australia, Northern Territory, Victoria & Queensland did not require further ethics approval.

Contacts
Principal investigator
Name 100394 0
Prof Steve Kisely
Address 100394 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road,
Woolloongabba, QLD 4102
Country 100394 0
Australia
Phone 100394 0
+61 7 3176 5859
Fax 100394 0
Email 100394 0
s.kisely@uq.edu.au
Contact person for public queries
Name 100395 0
Prof Steve Kisely
Address 100395 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road,
Woolloongabba, QLD 4102
Country 100395 0
Australia
Phone 100395 0
+61 7 3176 5859
Fax 100395 0
Email 100395 0
s.kisely@uq.edu.au
Contact person for scientific queries
Name 100396 0
Prof Steve Kisely
Address 100396 0
Level 4, Building 1, Princess Alexandra Hospital, Ipswich Road,
Woolloongabba, QLD 4102
Country 100396 0
Australia
Phone 100396 0
+61 7 3176 5859
Fax 100396 0
Email 100396 0
s.kisely@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a Data linkage study using large datasets with de-identified data under the jusrisdiction of the Data Custodians.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7734 0
Study protocol
Citation [1] 7734 0
Link [1] 7734 0
Email [1] 7734 0
Other [1] 7734 0
Type [2] 7735 0
Statistical analysis plan
Citation [2] 7735 0
Link [2] 7735 0
Email [2] 7735 0
Other [2] 7735 0
The analysis plan can be found on pg 11 of the attached Technical Assessment Form.
Type [3] 7736 0
Ethical approval
Citation [3] 7736 0
Link [3] 7736 0
Email [3] 7736 0
Other [3] 7736 0
The University of Queensland Institutional Human Research Ethics Approval
Type [4] 7747 0
Ethical approval
Citation [4] 7747 0
Link [4] 7747 0
Email [4] 7747 0
Other [4] 7747 0
Australian Institute of Health & Welfare (AIHW) Ethics Committee approval
Type [5] 7748 0
Ethical approval
Citation [5] 7748 0
Link [5] 7748 0
Email [5] 7748 0
Other [5] 7748 0
Tasmania Health and Medical Human Research Ethics Committee approval
Type [6] 7749 0
Ethical approval
Citation [6] 7749 0
Link [6] 7749 0
Email [6] 7749 0
Other [6] 7749 0
Department of Health WA Human Research Ethics Committee approval
Type [7] 8082 0
Ethical approval
Citation [7] 8082 0
Link [7] 8082 0
Email [7] 8082 0
Other [7] 8082 0
NSW Population and Health Service Research Ethics Committee approval
Summary results
No Results