Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000872033
Ethics application status
Not yet submitted
Date submitted
5/10/2010
Date registered
18/10/2010
Date last updated
18/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving rural cancer outcomes
Scientific title
A new multi-level complex intervention to redress delays in symptoms appraisal, general practitioner (GP) diagnosis and referral and access to optimal treatments for rural patients with cancer - development phase
Secondary ID [1] 252649 0
N/A
Universal Trial Number (UTN)
Trial acronym
IRCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 258369 0
Condition category
Condition code
Cancer 258322 258322 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 258323 258323 0 0
Breast
Cancer 258324 258324 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a multi-level complex 'best prospects' intervention will be designed based on a review of the available literature (from all periods) as well as qualitative assessments. The intervention will be designed to redress health system, doctor and patient factors that affect outcomes in rural patients with cancer of the prostate, breast, colorectum or lung. It is expected that the development phase will take approx. 2 years.
Intervention code [1] 257158 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259176 0
The initial development phase will measure the different components of delay to treatment that could impact on poorer outcomes in rural cancer patients and gather knowledge of patient decision-making about symptom appraisal and the type and location of treatment of their cancer.
Timepoint [1] 259176 0
In the development phase of the study
Secondary outcome [1] 265521 0
Delay times in rural patients newly presenting with cancer using surveys and questionnaires
Timepoint [1] 265521 0
In the intervention phase of the study
Secondary outcome [2] 265908 0
Clinical endpoints (including stage at diagnosis, optimal Initial treatment, inactive disease after initial treatment, time to recurrence and time to death) using information from medical records
Timepoint [2] 265908 0
In the intervention phase of the study
Secondary outcome [3] 265909 0
Patient confidence in providers and satisfaction with care using questionnaires and interviews.
Timepoint [3] 265909 0
In the intervention phase of the study

Eligibility
Key inclusion criteria
eligible and consenting patients living in selected rural areas with newly diagnosed
cancers of the prostate, breast, colorectum or lung
Minimum age
0 Years
Maximum age
0 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257613 0
Government body
Name [1] 257613 0
National Health & Medical Research Council (NHMRC)
Country [1] 257613 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Population Health & School of Primary, Aboriginal and Rural Health Care, University of Western Australia
35 Stirling Highway, CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 256835 0
Other Collaborative groups
Name [1] 256835 0
Primary Care Collaborative Cancer Clinical Trials Group (PC4)
Address [1] 256835 0
The University of Western Australia
M706, 328 Stirling Highway
Claremont WA 6010
Country [1] 256835 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259632 0
Ethics committee address [1] 259632 0
Ethics committee country [1] 259632 0
Date submitted for ethics approval [1] 259632 0
01/01/2011
Approval date [1] 259632 0
Ethics approval number [1] 259632 0

Summary
Brief summary
The project will consist of two intimately-linked phases over a five-year term: a development phase, which will identify health system, doctor and patient factors that affect outcomes in rural patients with cancer of the prostate, breast, colorectum or lung and assess their potential to be modified by a complex intervention; and an implementation/evaluation phase, in which the ‘best prospects’ intervention will be rigorously evaluated by an experimental trial.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31616 0
Address 31616 0
Country 31616 0
Phone 31616 0
Fax 31616 0
Email 31616 0
Contact person for public queries
Name 14863 0
Victoria Gray
Address 14863 0
M431 School of Population Health, The University of Western Australia, 35 Stirling Highway, CRAWLEY WA 6009
Country 14863 0
Australia
Phone 14863 0
+61 8 6488 7379
Fax 14863 0
Email 14863 0
[email protected]
Contact person for scientific queries
Name 5791 0
Professor Jon Emery
Address 5791 0
M431 School of Population Health, The University of Western Australia, 35 Stirling Highway, CRAWLEY WA 6009
Country 5791 0
Australia
Phone 5791 0
+61 8 9449 5140
Fax 5791 0
Email 5791 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Improving Rural Cancer Outcomes Trial: A cluster-randomised controlled trial of a complex intervention to reduce time to diagnosis in rural cancer patients in Western Australia.2017https://dx.doi.org/10.1038/bjc.2017.310
EmbaseThe Improving Rural Cancer Outcomes (IRCO) Trial: A factorial clusterrandomised controlled trial of a complex intervention to reduce time to diagnosis in rural patients with cancer in Western Australia: A study protocol.2014https://dx.doi.org/10.1136/bmjopen-2014-006156
N.B. These documents automatically identified may not have been verified by the study sponsor.