Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000893202
Ethics application status
Approved
Date submitted
14/09/2009
Date registered
13/10/2009
Date last updated
4/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Changes With Adjuvant Therapy For Breast Cancer: A Longitudinal Study
Scientific title
Longitudinal study assessing changes in cognitive function induced by adjuvant therapy in women with early stage breast cancer
Secondary ID [1] 280701 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 243823 0
Condition category
Condition code
Cancer 239996 239996 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention related to the trial - only observation of changes in cognitive function induced by adjuvant therapy over the first two years from initiation of treatment (the choice of which is not influenced by participation in this study).
Intervention code [1] 241262 0
Not applicable
Comparator / control treatment
Each patient is being assessed longitudinally and will serve as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240899 0
The incidence of deficits in cognitive function associated with adjuvant therapies for breast cancer over a 2 year period using questionnaires and tests of memory, concentration, processing skills and task completion.
Timepoint [1] 240899 0
Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)
Secondary outcome [1] 257585 0
The time course of deficits in cognitive function associated with adjuvant therapies for breast cancer over a 2 year period.
Timepoint [1] 257585 0
Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)
Secondary outcome [2] 257587 0
Changes in quality of life during adjuvant therapies for breast cancer using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 quality of life questionnaire
Timepoint [2] 257587 0
Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)
Secondary outcome [3] 257588 0
Changes in mood during adjuvant therapies for breast cancer assessed using questionnaires
Timepoint [3] 257588 0
Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)
Secondary outcome [4] 257589 0
The role played by menopausal status in cognitive functioning during adjuvant therapies for breast cancer (with menopausal status established by direct questioning of patients)
Timepoint [4] 257589 0
Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)

Eligibility
Key inclusion criteria
1.Women diagnosed with early breast cancer treated by surgery with curative intent
2. Adjuvant therapy is planned (chemotherapy, hormone therapy, radiotherapy, or any combination of the above)
3. Fluency in English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current use of hormone replacement therapy or hormonal contraception
2. Severe current mental illness
3. Not able to comply with the test requirements
4. Pre-existing significant neurological impairment

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2003
Actual
20/11/2003
Date of last participant enrolment
Anticipated
Actual
23/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2137 0
New Zealand
State/province [1] 2137 0

Funding & Sponsors
Funding source category [1] 243724 0
Charities/Societies/Foundations
Name [1] 243724 0
Waikato Medical Research Foundation
Country [1] 243724 0
New Zealand
Funding source category [2] 243725 0
Charities/Societies/Foundations
Name [2] 243725 0
Genesis Oncology Trust
Country [2] 243725 0
New Zealand
Funding source category [3] 243726 0
Charities/Societies/Foundations
Name [3] 243726 0
The Bay Cancer Research & Support Trust
Country [3] 243726 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Jameson
Address
Regional Cancer Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 237088 0
Hospital
Name [1] 237088 0
Waikato District Health Board
Address [1] 237088 0
Private Bag 3200
Hamilton 3240
Country [1] 237088 0
New Zealand
Other collaborator category [1] 859 0
Individual
Name [1] 859 0
Professor Barbara Hedge
Address [1] 859 0
Dept of Psychology
University of Waikato
Private Bag 3105
Hamilton 3240
Country [1] 859 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243853 0
Waikato Ethics Committee
Ethics committee address [1] 243853 0
Ethics committee country [1] 243853 0
New Zealand
Date submitted for ethics approval [1] 243853 0
Approval date [1] 243853 0
29/07/2003
Ethics approval number [1] 243853 0
WAI/03/05/033

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30276 0
Dr Michael Jameson
Address 30276 0
Regional Cancer Centre Waikato Hospital Private Bag 3200 Hamilton 3240
Country 30276 0
New Zealand
Phone 30276 0
+64 7 839 8604
Fax 30276 0
+64 7 839 8778
Email 30276 0
michael.jameson@waikatodhb.health.nz
Contact person for public queries
Name 13523 0
Dr Michael Jameson
Address 13523 0
Regional Cancer Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 13523 0
New Zealand
Phone 13523 0
+64 7 839 8604
Fax 13523 0
+64 7 839 8778
Email 13523 0
michael.jameson@waikatodhb.health.nz
Contact person for scientific queries
Name 4451 0
Dr Michael Jameson
Address 4451 0
Regional Cancer Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 4451 0
New Zealand
Phone 4451 0
+64 7 839 8604
Fax 4451 0
+64 7 839 8778
Email 4451 0
jameson@waikatodhb.govt.nz

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
No additional documents have been identified.