Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12618001555246
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A trial to increase participation in the National Bowel Cancer Screening Program by eligible Indigenous clients of participating primary health care centres that receive either an intensive model of support or a low intensity model of support in offering screening.
Query!
Scientific title
Alternative Pathway for the National Bowel Cancer Screening Program for Indigenous Australians: A randomised cluster trial of implementation models
Query!
Secondary ID [1]
295994
0
Nil Known
Query!
Universal Trial Number (UTN)
U1111-1219-9537
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer
309519
0
Query!
Condition category
Condition code
Cancer
308349
308349
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Intervention Arm A (low intensity support) - Primary health care centres in this arm are offered a low intensity model of support to prepare them to offer the National Bowel Cancer Screening Program bowel screening kit to their eligible clients (aged 50-74). This support includes access to an online training module for health centre staff about bowel cancer and bowel cancer screening and other resources to assist them to deliver the program to their clients. When eligible clients attend the health centre they will be invited to screen and receive a bowel screening kit as part of the Alternative Pathway.
The on-line training module includes the following topics: About bowel cancer and bowel cancer screening; Risk factors for bowel cancer; Bowel cancer treatment; Incidence, survival and screening participation rates; About the National Bowel Cancer Screening Program; About the Alternative Pathway; Talking about bowel screening with your Indigenous clients (clinical and social aspects); Assessing suitability for screening; Understanding test results; General Practitioner assessment; Colonoscopy; Risks and benefits of screening.
The online training module will take health professionals about one hour to complete. It was designed specifically for the pilot to relate directly to the context of primary health care centres and health professionals providing services to Indigenous clients in the eligible age group. It includes the use of animations, a music video, and with voiceovers by Aboriginal and Torres Strait Islander actors (two male, one female). Short quizzes (three to six questions each) test participant knowledge and learning throughout the module. Designed primarily for Indigenous Health Workers, the resources can be used by other health professionals.
Other resources developed specifically for this project and provided as part of the low intensity support model include:
- A manual for implementation: 'The Alternative Pathway in your Health Centre' provides primary health care centre managers and staff with the information to prepare for and deliver the Alternative Pathway, such as how the Alternative pathway differs from the usual pathway for accessing the National Bowel Cancer Screening Program; what needs to be done before health centres will be able to offer the Alternative Pathway to their eligible Indigenous clients; requirements for managing test kits (both before and after samples are taken); obtaining client consent and providing client information through the secure online Participant Details (Health Centre Initiated) form; receiving client results electronically or on paper from the Program’s pathology provider; Program follow-up procedures for individuals who receive a kit but do not complete it, or who receive a positive result and do not proceed with a General Practitioner assessment and/or colonoscopy if referred; requirements for General Practitioner assessments; access to colonoscopy and supporting clients who are referred for colonoscopy. It includes A Checklist for Talking about Bowel Screening with your clients; flowcharts for the National Bowel Cancer Screening Program and the Alternative Pathway; templates to support implementation planning (based on the Consolidated Framework for Implementation Research, https://cfirguide.org); descriptions of the Alternative Pathway resources for health professionals and for clients; key contacts.
- Motivational poster (‘Bowel screening saves lives’) to prompt health professionals to talk to their clients about bowel screening
- Information sheets: one for Indigenous Health Workers and one for General Practitioners. Each sheet presents information about why bowel screening is important for Indigenous people, and addresses specific barriers that were identified in previous studies or consultations as affecting each of these two professional groups.
- A flipchart with information presented visually or in plain language on one side of the flipchart, with text for presentation by an Indigenous Health Worker on the other side. The flip chart covers key information for Indigenous adults about bowel cancer, bowel screening, and how to do the test.
- A poster for display in the health centre ‘Don’t delay, do a bowel test today’, that encourages eligible patients to talk to their doctor or health worker about screening.
- A brochure with basic information about bowel screening, ‘Bowel screening: It’s not shame, it’s a way of life’ and space for an appointment time to be written on the back.
- Access to support lines:
* The National Bowel Cancer Screening Program Information Line (part of the Program’s Business as Usual support services).
* The National Bowel Cancer Screening Program Health Provider Hotline (to the Program’s pathology provider, also part of the Program’s Business as Usual support.
* A National Pilot Support Officer within the Department of Human Services who will assist with interaction between the Program Register and participating health centres.
* Menzies School of Health Research Site Support, a helpline to Menzies Project Team staff who will provide responses to queries relating specifically to the implementation and evaluation of the Alternative Pathway, training, and any questions related to the research aspects of the Pilot, and refer questions about the national Program, Register or pathology to the other support lines as relevant.
Fidelity of training delivery is ensured by:
- all training materials have been endorsed by the Department of Health as adhering to the requirements of the National Bowel Cancer Screening Program (see also below under Comparator/Control for measures to ensure fidelity in face to face workshops and in-services)
- all participating health centres will have access to the same online training module, implementation manual and other resources provided for health centres in Arm A.
Fidelity and adherence in the delivery of the Alternative Pathway at health centre level is ensured through:
- all participating primary health care centres must complete a Quality and Safety Checklist to a satisfactory standard before the health centre will be provided with National Bowel Cancer Screening Program kits. The Quality and Safety Checklist covers potential risks identified by the National Bowel Cancer Screening Program, and during previous research, that health centres will need to manage, such as safe storage of screening kits, staff skill levels, timely access to colonoscopy, privacy and confidentiality issues. Health centres complete the Checklist to demonstrate how they will manage the risks. Once the Quality and Safety Checklist is submitted, it will be assessed by members of the Menzies Project Team and Department of Health representatives for the National Bowel Cancer Screening Program. As a quality and safety measure, health centres may resubmit if initial efforts are not satisfactory. Once completed to a satisfactory level, health centres will be able to invite eligible patients to screen, assess their screening suitability, and offer screening kits as part of the Alternative Pathway.
- use of a secure Online Form for all participating health centre staff to report standardised details about their assessment of health centre clients for screening.
Additional support components offered to Arm B will be offered to Arm A at the end of the Pilot: Health centres in Arm B (intensive model of support) will receive additional support components (described in detail below) prior to beginning to offer the Alternative Pathway to their eligible Indigenous clients. If effective, these additional components of support will be made available to health centres in Arm A following the end of the 12 month period in which health centres give out kits to their clients.
Query!
Intervention code [1]
312327
0
Early detection / Screening
Query!
Comparator / control treatment
Intervention Arm B (intensive support) - Primary health care centres in this arm are offered an intense model of support in preparing to offer the Alternative Pathway to eligible clients (aged 50-74). This Arm will receive the same resources as Arm A but the health centre staff will also receive one face to face visit from the project team to conduct training and facilitate the health centre's preparation to offer the Alternative Pathway. Team members conducting training will hold a minimum qualification of Cert IV training and assessment or equivalent experience. Eligible clients attending the health service will be invited to screen and receive a bowel screening kit from their Indigenous Health Centre as part of the Alternative Pathway.
The additional components of support offered to health centres in Arm B will include:
- staff attendance at one of three face to face training workshops held at regional centres: Regional workshops will be offered to Indigenous Health Workers before their respective health centres begin to give out screening kits. Workshop content includes the same topics as the Online Module included in the package of resources and support materials, but provides opportunities for tailoring and reinforcement of learning through question and answer sessions; workshop discussions; role playing; learning from peers and networking with colleagues from other health centres. In particular, the workshops allow greater focus on techniques for raising the topic of bowel screening with clients, practicing these techniques, and demonstrating how to do the test. Travel and accommodation assistance with be available for up to ten Indigenous Health Worker participants at each workshop. Each regional workshop will be delivered by at least two facilitators with a minimum qualification of Cert IV Training and Assessment or equivalent experience. They will also have combined expertise that includes cancer knowledge, familiarity with the National Bowel Cancer Screening Program and the requirements of the Alternative Pathway; familiarity with the contexts of Indigenous Primary Health Care Centres; and relevant Indigenous cultural knowledge and community standing. Where possible, workshops will include a co-facilitator from the local area. A fourth workshop will be offered five months into the Pilot to provide the training opportunity for any new staff members starting work after the start of the pilot at participating health centres in Arm B.
Facilitation of implementation planning and in-service training sessions: Each health centre in Arm B will receive a site visit from Menzies Project Team members prior to health centres offering the Alternative Pathway. Health centres will be offered a selection of brief training or facilitated discussion sessions, including: Introduction to the Alternative Pathway; Understanding Bowel Cancer and Screening In-service; Assessing Suitability, Offering Screening and the Online Form; Completing the Test; Facilitated Discussion of implementation issues.
Monthly contact with each centre will be from the Menzies Project Team Site Support Officer: This contact will be made by phone (or by email if phone contact is unsuccessful). The contact will be initiated by the project team as a prompt for the health centre to stay focused on the Alternative Pathway and provide an opportunity to troubleshoot or problem solve.
Fidelity of training delivery is ensured by:
- all training materials have been endorsed by the Department of Health as adhering to the requirements of the National Bowel Cancer Screening Program
- all participating health centres will have access to the same online training module, implementation manual and other resources provided for health centres in Arm A - same package of resources provided to Arm B.
- for face to face training and inservices, a standardised Powerpoint presentation has been endorsed by the Department of Health as adhering to the requirements of the National Bowel Cancer Screening Program, and facilitators will use a standardised Facilitator Handbook to guide delivery.
Fidelity and adherence in the delivery of the Alternative Pathway at health centre level is ensured as described above in the Description of Intervention.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
307336
0
Outcome: Screening participation by client population
The primary outcome is the screening participation rate in the National Bowel Cancer Screening Program by Indigenous people aged 50 to 74, who are clients of participating primary health care centres that have received low intensity (Arm A) or intensive support (Arm B) in offering screening to their clients.
The client population screening participation rate is calculated as the total number of eligible (aged 50 to 74) Indigenous clients of a participating primary health care centre, who return for testing a National Bowel Cancer Screening Program kit received from the health centre during the 12 months following commencement of the trial; as a proportion of the total number of active eligible (aged 50 to 74) Indigenous clients of that health centre. (An active client is defined by the Royal Australian College of General Practitioners and the National Aboriginal Community Controlled Health Organisations as: A patient who has attended the practice/service three or more times in the past 2 years.)
Number of clients who returned kits for testing and total active eligible Indigenous clients for each health centre will be aggregated to compare the population screening participation rates of eligible (aged 50 to 74) Indigenous clients of health centres that are:
- in Arm A and Arm B;
- in different categories of remoteness (urban, regional, remote);
- in different jurisdictions (states/territories);
- in different Hot Zone restriction categories (Number of months by which an area is restricted by the National Bowel Cancer Screening Program from distributing kits during months in which the average monthly temperature is higher than 30 degrees Celsius.)
The outcome will also be compared with the screening participation rate of Indigenous Australians through the usual pathway of the National Bowel Cancer Screening Program, as reported by the Australian Institute of Health and Welfare in the Program’s annual monitoring report, at baseline (within two months prior to commencement of the trial) and at 12 and 18 months following commencement of the trial.
Query!
Assessment method [1]
307336
0
Query!
Timepoint [1]
307336
0
Timepoint (1):
- Screening participation measured after 12 months following commencement of trial; and at 18 months after commencement of trial. (The National Bowel Cancer Screening Program allows six months after the distribution of kits for screening participants to return the completed kits for testing.)
- Active Client population measured at commencement of trial and at 12 months following commencement of trial. (Number of active clients and other health centre characteristics will be reported by participating health centres at baseline through an online Health Centre Profile form, completed as part of the application process to take part in the trial, and updated at six and twelve months following commencement of the trial)
Query!
Secondary outcome [1]
351497
0
Outcome: Screening participation by clients invited to screen
The rate of screening participation in the National Bowel Cancer Screening Program by Indigenous people aged 50 to 74, who are invited to screen by participating primary health care centres that have received low intensity (Arm A) or intensive support (Arm B) in offering screening to their clients.
The screening participation rate of clients invited to screen is calculated as the total number of eligible (aged 50 to 74) Indigenous clients of a participating primary health care centre, who return for testing a National Bowel Cancer Screening Program kit received from the health centre during the 12 months following commencement of the trial; as a proportion of the total number of eligible (aged 50 to 74) Indigenous clients who are assessed for screening by a participating primary health care centre over the 12 months following commencement of the trial.
Number of clients who returned kits for testing and total number of eligible (aged 50 to 74) Indigenous clients for each health centre will be aggregated to compare the population screening participation rates of eligible (aged 50 to 74) Indigenous clients of health centres that are:
- in Arm A and Arm B;
- in different categories of remoteness (urban, regional, remote);
- in different jurisdictions (states/territories);
- in different Hot Zone restriction categories (Definition of Hot Zone Restriction: Number of months by which an area is restricted by the National Bowel Cancer Screening Program from distributing kits during months in which the average monthly temperature is higher than 30 degrees Celsius.)
And compared with the screening participation rate of Indigenous Australians through the usual pathway of the National Bowel Cancer Screening Program, reported by the Australian Institute of Health and Welfare in the Program’s annual monitoring report, at baseline (within two months prior to commencement of the trial) and at 12 and 18 months following commencement of the trial.
Query!
Assessment method [1]
351497
0
Query!
Timepoint [1]
351497
0
Timepoint:
- Screening participation measured after 12 months and 18 months following commencement of trial, using National Bowel Cancer Screening Register data and data provided by health professionals about clients invited to screen (assessed).
- Health centre characteristics reported by participating health centres at baseline through Health Centre Profile, completed online as part of the application process to take part in the trial, and updated at six and twelve months following commencement of the trial.
Query!
Secondary outcome [2]
351499
0
Outcome: Sample quality (Proportion of ‘No Result’ or ‘Inconclusive’ results)
National Bowel Cancer Screening Program test samples that receive a result of ‘No Result’ or ‘Inconclusive’ are an indicator of whether samples have been collected, stored or transported properly, and as such, contribute to understanding the feasibility of offering the Program through an Alternative Pathway.
The proportion of samples that receive a result of ‘No Result’ or ‘Inconclusive’ will be calculated from the number of eligible (aged 50 to 74) Indigenous clients of a participating primary health care centre, who receive ‘No Result’ or ‘Inconclusive’ results after returning for testing a National Bowel Cancer Screening Program kit received from the health centre during the 12 months following commencement of the trial; as a proportion of the total number of eligible (aged 50 to 74) Indigenous clients who return for testing a National Bowel Cancer Screening Program kit received from the health centre during the 12 months following commencement of the trial.
Number of clients who received ‘No Result’ or ‘Inconclusive’ results and total number of clients who returned a completed National Bowel Cancer Screening Program kit for testing will be aggregated to compare the proportion of ‘No Result’ and ‘Inconclusive’ results of eligible (aged 50 to 74) Indigenous clients of health centres that are:
- in Arm A and Arm B;
- in different categories of remoteness (urban, regional, remote);
- in different jurisdictions (states/territories);
- in different Hot Zone restriction categories (Number of months by which an area is restricted by the National Bowel Cancer Screening Program from distributing kits during months in which the average monthly temperature is higher than 30 degrees Celsius.)
Query!
Assessment method [2]
351499
0
Query!
Timepoint [2]
351499
0
- Test results for clients who returned kits for testing that they received from participating health centres, at 12 months after commencement of trial and at 18 months after commencement of trial, measured using National Bowel Cancer Screening Register data.
- health centre characteristics as described in secondary timepoint (1).
Query!
Secondary outcome [3]
351501
0
Outcome: Feasibility and acceptability of Alternative Pathway
The feasibility and acceptability of offering an Alternative Pathway for Indigenous Australians for the National Bowel Cancer Screening Program through primary health care centres will be assessed from:
(a) Descriptions from health centre staff and managers of how the Alternative Pathway was offered by a participating health centre, and their perspectives on the feasibility and acceptability of offering the Alternative Pathway to eligible Indigenous clients through primary health care centres, including assessment of costs and benefits;
(b) The health centre’s screening participation rates (for client population and clients invited to screen, as described in the Primary Outcome and Secondary Outcome 1);
(c) The quality of samples returned by clients of a health centre, as described in Secondary Outcome 2.
and in relation to the level of support (intensive, low intensity) received in preparing to offer screening; level of remoteness; state/territory; Hot Zone restrictions; other health centre characteristics such as health centre type, staffing and client numbers.
*Qualitative data about health centre characteristics; cancer screening promotion or related activity; and about the environment in which the health centre operates, will be used to further explore factors that may contribute to this and other outcomes.
Query!
Assessment method [3]
351501
0
Query!
Timepoint [3]
351501
0
Timepoint:
- Data gathered from health centre staff and managers using the Semi-Structured Interview Tool during a single visit to each site (Arm A and B), conducted in a period between 12 and 16 months after commencement of the trial.
- Screening participation measured after 12 months following commencement of trial, using data from the National Bowel Cancer Screening Register and data provided by health professionals about client’s assessed for screening.
- Sample quality, measured as described in Secondary Outcome 2.
- Additional qualitative data gathered through the following data collection tools:
Supporting Agency Activity Report: Completed by nominated officers of a Supporting Agency (an organisation such as a Cancer Council, Primary Health Network, state or territory health department, active in a jurisdiction in which a participating health centre is located) about cancer screening related activity that may have influenced participating primary health care centres during the 12 months following commencement of the trial; collected at three, six, nine and 12 months following commencement of the trial. The Supporting Agency Activity Report will be administered as an online survey using Qualtrics.
- inquiries from health centres to Menzies Site Support (by phone call or email), logged in the Inquiries Log.
Query!
Secondary outcome [4]
351780
0
Secondary outcome 4: Sustainability of Alternative Pathway
The sustainability of offering the Alternative Pathway as an ongoing option for Indigenous people to take part in the National Bowel Cancer Screening Program.
Sustainability will be assessed from:
(a) Descriptions from health centre staff and managers of how the Alternative Pathway was offered by a participating health centre, including changes over the 12 months of the trial; and their perspectives on the sustainability of offering the Alternative Pathway to eligible Indigenous clients through primary health care centres;
(b) The health centre’s screening participation rates (for client population and clients invited to screen, as described in the Primary Outcome and Secondary Outcome 1);
and in relation to the level of support (intensive, low intensity) received in preparing to offer screening; level of remoteness; state/territory; Hot Zone restrictions; health centre characteristics such as health centre type, staffing and client numbers; cancer screening promotion or other activity; and the participation rate calculated for Indigenous participation in the National Bowel Cancer Screening Program’s usual pathway (outside the trial), as reported by the Australian Institute of Health and Welfare in the Program’s annual monitoring report.
Query!
Assessment method [4]
351780
0
Query!
Timepoint [4]
351780
0
- Data gathered from health centre staff and managers using the Semi-Structured Interview Tool during a single visit to each site (Arm A and B), conducted in a period between 12 and 16 months after commencement of the trial.
- Screening participation measured after 12 months following commencement of trial, using data from the National Bowel Cancer Screening Register and data provided by health professionals about client’s assessed for screening.
Query!
Eligibility
Key inclusion criteria
1. The Indigenous Primary Health Care Centre meets the definition of:
• A Primary Health Care Centre with a majority Indigenous patient population; or,
• A Primary Health Care Centre that does not have a majority of patients who are Indigenous, but has at least 50 Indigenous patients aged 50 to 74 years and wishes to make improving Indigenous participation in bowel screening an organisational priority.
Indigenous Primary Health Care Centres may include:
• Aboriginal Community Controlled Organisations (ACCHOs)
• Primary Health Care Centres run by state or territory health services
• Private or corporate general practices
• Other types of Primary Health Care Services (for example, chronic disease teams).
2. At least fifty (50) Aboriginal and Torres Strait Islander patients in the eligible age group for the National Bowel Cancer Screening Program (aged 50 to 74) who are active patients under the National Aboriginal Community Controlled Organisations/The Royal Australians College of General Practitioners definition: A patient who has attended the practice/service three or more times in the past 2 years (Source: Glossary, Interpretive Guide to the Royal Australian College of General Practitioners Standards, for Aboriginal community controlled health services).
3. The Indigenous Primary Health Care Centre must deliver at least some primary health care services to Aboriginal and Torres Strait Islander people, have capacity to support the Alternative Pathway, and have access to a General Practitioner who can assess patients who receive a positive result and refer on to further diagnostic testing if required.
4. Internet access, a computer (or similar) that allows the Indigenous Primary Health Care Centre staff to provide information to the Register and a printer to print out the Health Centre Initiated Participant Details form.
5. Ability for cool storage of the National Bowel Cancer Screening Program screening kits (less than 30 degrees) at the Indigenous Primary Health Care Centre.
6. Ability and willingness to execute a Participation Agreement
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
74
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. Conditions in the location or region of the Indigenous Primary Health Care Centre are assessed as unsuitable for participation and unable to be managed through the Quality and Safety Checklist process; for example, barriers to timely access to colonoscopy, hot zone or postal limitations.
2. No way to establish bowel screening into routine practice.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician will provide the randomisation codes to an independent allocator not associated with the study team. The Indigenous Primary Health Care Centres at time of enrolment will be randomised 1:1 to Group A or Group B by the independent allocator.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Additional support components offered to Arm B will be offered to Arm A at end of Pilot: Health centres in Arm B (intensive model of support) will receive additional support components prior to beginning to offer the Alternative Pathway to their eligible Indigenous clients. If effective, these additional components of support will be made available to health centres in Arm A following the end of the 12 month period in which health centres give out kits to their clients.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Regression Analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/10/2018
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
5/11/2018
Query!
Actual
Query!
Date of last data collection
Anticipated
30/04/2020
Query!
Actual
Query!
Sample size
Target
900
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
300589
0
Government body
Query!
Name [1]
300589
0
Australian Government Department of Health
Query!
Address [1]
300589
0
Department of Health
GPO Box 9848,
Canberra ACT 2601, Australia
Query!
Country [1]
300589
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
Menzies School of Health Research
Query!
Address
Menzies School of Health Research
Level 1, 147 Wharf Street
Spring Hill, QLD 4000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
300097
0
None
Query!
Name [1]
300097
0
Query!
Address [1]
300097
0
Query!
Country [1]
300097
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301376
0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Query!
Ethics committee address [1]
301376
0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research Post Office Box 41096 Casuarina Northern Territory 0811
Query!
Ethics committee country [1]
301376
0
Australia
Query!
Date submitted for ethics approval [1]
301376
0
01/11/2016
Query!
Approval date [1]
301376
0
20/01/2017
Query!
Ethics approval number [1]
301376
0
2017-2717
Query!
Ethics committee name [2]
301383
0
Aboriginal Health & Medical Medical Research Council NSW
Query!
Ethics committee address [2]
301383
0
PO Box 1565 Strawberry Hills, NSW 2012
Query!
Ethics committee country [2]
301383
0
Australia
Query!
Date submitted for ethics approval [2]
301383
0
20/01/2017
Query!
Approval date [2]
301383
0
14/03/2017
Query!
Ethics approval number [2]
301383
0
1247/17
Query!
Ethics committee name [3]
301384
0
Aboriginal Health Research Ethics Committee SA
Query!
Ethics committee address [3]
301384
0
Aboriginal Health Research Ethics Committee SA 220 Franklin Street, Adelaide 5000
Query!
Ethics committee country [3]
301384
0
Australia
Query!
Date submitted for ethics approval [3]
301384
0
28/01/2017
Query!
Approval date [3]
301384
0
09/03/2017
Query!
Ethics approval number [3]
301384
0
04-17-711
Query!
Ethics committee name [4]
301385
0
Western Australian Aboriginal Health Ethics Committee
Query!
Ethics committee address [4]
301385
0
PO Box 8493 Stirling Street, Perth, Western Australia, 6849
Query!
Ethics committee country [4]
301385
0
Australia
Query!
Date submitted for ethics approval [4]
301385
0
23/01/2017
Query!
Approval date [4]
301385
0
02/03/2017
Query!
Ethics approval number [4]
301385
0
763
Query!
Summary
Brief summary
The purpose of this study is to assess whether an alternative method (called the ‘Alternative Pathway’) of offering the National Bowel Cancer Screening Program via primary health care centres can improve Indigenous participation rates. Who is it for? You may be eligible for this study if you are an Aboriginal and Torres Strait Islander person aged 50 to 74 who attends an Indigenous Primary Health Care Centre that is taking part in the study. Study details Potential screening participants will be randomised (by chance) into two groups depending on the health centre they attend. One group of centres (called Group A) will offer participants a bowel screening kit as part of the Alternative Pathway. The other group of centres (Group B) will also offer participants a bowel screening kit as part of the Alternative Pathway, however staff at these centres will have received additional training from the research team. Screening kits will be the same as those used in the usual method of offering the National Bowel Cancer Screening Program. Samples will be tested, results reported to participants and follow up of positive results will all occur within the national program as usual.. Reports from the National Bowel Cancer Screening Register and from Indigenous Health Centres will be analysed to see how many Indigenous people complete a bowel screening test offered through the Alternative Pathway, and whether extra training for health centre staff makes any difference to the screening rate. It is hoped this research will raise awareness and increase accessibility for Indigenous Australians to participate in the bowel screening program, enabling early detection of bowel cancer to improve survival outcome for Indigenous Australians.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
86802
0
Prof Gail Garvey
Query!
Address
86802
0
c/o Menzies School of Health Research
Po Box 10639
Brisbane Queensland 4000
Query!
Country
86802
0
Australia
Query!
Phone
86802
0
+617 31694200
Query!
Fax
86802
0
Query!
Email
86802
0
[email protected]
Query!
Contact person for public queries
Name
86803
0
Gail Garvey
Query!
Address
86803
0
c/o Menzies School of Health Research
Po Box 10639
Brisbane Queensland 4000
Query!
Country
86803
0
Australia
Query!
Phone
86803
0
+617 31694200
Query!
Fax
86803
0
Query!
Email
86803
0
[email protected]
Query!
Contact person for scientific queries
Name
86804
0
Gail Garvey
Query!
Address
86804
0
c/o Menzies School of Health Research
Po Box 10639
Brisbane Queensland 4000
Query!
Country
86804
0
Australia
Query!
Phone
86804
0
+617 31694200
Query!
Fax
86804
0
Query!
Email
86804
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
n/a
Documents added automatically
No additional documents have been identified.
Download to PDF