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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients receiving chemotherapy for B cell lymphoma or early breast cancer 983 0
Condition category
Condition code
Cancer 1058 1058 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 778 0
None
Comparator / control treatment
This is 6 months for the breast cancer patients and 3 months for the Lymphoma
Control group
Active

Outcomes
Primary outcome [1] 1415 0
Measurement of patient mental state.
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)
Secondary outcome [1] 2501 0
1. Number of non treatment visits to tertiary setting.
Timepoint [1] 2501 0
Secondary outcome [2] 2502 0
2. Cost benefit to the tertiary setting
Timepoint [2] 2502 0
Secondary outcome [3] 2503 0
3 GP confidence
Timepoint [3] 2503 0

Eligibility
Key inclusion criteria
Newly diagnosed B cell lymphoma or early breast cancer patients receiving adjuvant chemotherapy.- Patient consent-GP consent.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand or complete trial documentation-Patient's GP is already participating in the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)

Funding & Sponsors
Funding source category [1] 1158 0
Government body
Name [1] 1158 0
NHMRC
Address [1] 1158 0
Country [1] 1158 0
Australia
Funding source category [2] 1159 0
Hospital
Name [2] 1159 0
SCGH Leukaemia Fund
Address [2] 1159 0
Country [2] 1159 0
Australia
Primary sponsor type
Individual
Name
Dr David Joske (Chief Investigator)
Address
Country
Secondary sponsor category [1] 1017 0
Individual
Name [1] 1017 0
Principal Investigators: Assoc Prof Alison Ward
Address [1] 1017 0
Country [1] 1017 0
Secondary sponsor category [2] 1018 0
Individual
Name [2] 1018 0
Prof Christobel Saunders
Address [2] 1018 0
Country [2] 1018 0
Secondary sponsor category [3] 1019 0
Individual
Name [3] 1019 0
Prof Jon Emery
Address [3] 1019 0
Country [3] 1019 0
Secondary sponsor category [4] 1020 0
Individual
Name [4] 1020 0
Dr Anna Nowak
Address [4] 1020 0
Country [4] 1020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2477 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 2477 0
Ethics committee country [1] 2477 0
Australia
Date submitted for ethics approval [1] 2477 0
Approval date [1] 2477 0
Ethics approval number [1] 2477 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36206 0
Address 36206 0
Country 36206 0
Phone 36206 0
Fax 36206 0
Email 36206 0
Contact person for public queries
Name 9967 0
Kate Overheu
Address 9967 0
c/- School of Surgery and Pathology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 9967 0
Australia
Phone 9967 0
+61 8 93464596
Fax 9967 0
+61 8 93462416
Email 9967 0
kate.overheu@health.wa.gov.au
Contact person for scientific queries
Name 895 0
Dr David Joske
Address 895 0
Haematology Care Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 895 0
Australia
Phone 895 0
+61 8 93467600
Fax 895 0
+61 8 93467607
Email 895 0
david.joske@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results