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Trial registered on ANZCTR
Registration number
ACTRN12606000022561
Ethics application status
Approved
Date submitted
30/11/2005
Date registered
13/01/2006
Date last updated
13/01/2006
Type of registration
Retrospectively registered
Titles & IDs
Public title
Cancer Shared Care Project Study
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Scientific title
Randomised Controlled Trial of a Shared Care Model of Care for patients receiving chemotherapy in a tertiary setting and their General Practitioners, to ascertain benefits to the patient's wellbeing, GP confidence and cost benefit to the tertiary health provider
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients receiving chemotherapy for B cell lymphoma or early breast cancer
983
0
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Condition category
Condition code
Cancer
1058
1058
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Shared Care model - comprised of
1. Patient Held Record
2. GP education
3. Increased GP involvement
4. Shared Care coordinator
The duration of the intervention/control will be for the length of time that the patient is receiving chemotherapy. patients.
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Intervention code [1]
778
0
None
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Comparator / control treatment
This is 6 months for the breast cancer patients and 3 months for the Lymphoma
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Control group
Active
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Outcomes
Primary outcome [1]
1415
0
Measurement of patient mental state.
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Assessment method [1]
1415
0
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Timepoint [1]
1415
0
Measured at commencement of the study, half way through the study (ie 6 weeks for lymphoma patients, 3 months for Breast Cancer patients and at the end of the study ie cessation of chemotherapy)
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Secondary outcome [1]
2501
0
1. Number of non treatment visits to tertiary setting.
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Assessment method [1]
2501
0
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Timepoint [1]
2501
0
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Secondary outcome [2]
2502
0
2. Cost benefit to the tertiary setting
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Assessment method [2]
2502
0
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Timepoint [2]
2502
0
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Secondary outcome [3]
2503
0
3 GP confidence
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Assessment method [3]
2503
0
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Timepoint [3]
2503
0
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Eligibility
Key inclusion criteria
Newly diagnosed B cell lymphoma or early breast cancer patients receiving adjuvant chemotherapy.- Patient consent-GP consent.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to understand or complete trial documentation-Patient's GP is already participating in the trial.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Envelopes containing randomisation are generated externally, then opened in front of patient by study coordinator after baseline surveys
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was done separately within each of the 4 main stata which are rural/metro and lymphoma/breast cancer. Permuted block randomisation used.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
11/11/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1158
0
Government body
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Name [1]
1158
0
NHMRC
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Address [1]
1158
0
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Country [1]
1158
0
Australia
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Funding source category [2]
1159
0
Hospital
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Name [2]
1159
0
SCGH Leukaemia Fund
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Address [2]
1159
0
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Country [2]
1159
0
Australia
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Primary sponsor type
Individual
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Name
Dr David Joske (Chief Investigator)
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Address
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Country
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Secondary sponsor category [1]
1017
0
Individual
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Name [1]
1017
0
Principal Investigators: Assoc Prof Alison Ward
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Address [1]
1017
0
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Country [1]
1017
0
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Secondary sponsor category [2]
1018
0
Individual
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Name [2]
1018
0
Prof Christobel Saunders
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Address [2]
1018
0
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Country [2]
1018
0
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Secondary sponsor category [3]
1019
0
Individual
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Name [3]
1019
0
Prof Jon Emery
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Address [3]
1019
0
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Country [3]
1019
0
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Secondary sponsor category [4]
1020
0
Individual
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Name [4]
1020
0
Dr Anna Nowak
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Address [4]
1020
0
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Country [4]
1020
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2477
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Sir Charles Gairdner Hospital
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Ethics committee address [1]
2477
0
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Ethics committee country [1]
2477
0
Australia
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Date submitted for ethics approval [1]
2477
0
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Approval date [1]
2477
0
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Ethics approval number [1]
2477
0
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Summary
Brief summary
A trial to determine the efficacy of a shared care model of care for patients receiving chemotherapy for lymphoma or breast cancer at Sir Charles Gairdner Hospital, WA.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
36206
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Address
36206
0
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Country
36206
0
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Phone
36206
0
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Fax
36206
0
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Email
36206
0
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Contact person for public queries
Name
9967
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Kate Overheu
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Address
9967
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c/- School of Surgery and Pathology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
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Country
9967
0
Australia
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Phone
9967
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+61 8 93464596
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Fax
9967
0
+61 8 93462416
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Email
9967
0
[email protected]
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Contact person for scientific queries
Name
895
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Dr David Joske
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Address
895
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Haematology Care Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
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Country
895
0
Australia
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Phone
895
0
+61 8 93467600
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Fax
895
0
+61 8 93467607
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Email
895
0
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Randomized controlled trial of shared care for patients with cancer involving general practitioners and cancer specialists.
2015
https://dx.doi.org/10.1200/JOP.2014.001569
N.B. These documents automatically identified may not have been verified by the study sponsor.
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