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Trial registered on ANZCTR


Registration number
ACTRN12607000542493
Ethics application status
Approved
Date submitted
25/09/2007
Date registered
23/10/2007
Date last updated
16/06/2024
Date data sharing statement initially provided
23/01/2019
Date results provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Function Substudy - A substudy to the SOFT trial (ACTRN12605000416695) which evaluates the cognitive function of premenopausal women with endocrine responsive breast cancer participating in SOFT.
Scientific title
A substudy to the SOFT trial (ACTRN12605000416695). The SOFT trial evaluates the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer.

The Co-SOFT substudy investigates cognitive function of patients participating in the SOFT parent trial at selected centres.
Secondary ID [1] 471 0
ANZ 0701
Universal Trial Number (UTN)
Trial acronym
Co-SOFT
Linked study record
ACTRN12605000416695 - SOFT

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in pre-menopausal breast cancer patients 2397 0
Condition category
Condition code
Cancer 2500 2500 0 0
Breast
Mental Health 2502 2502 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to registration in the Co-SOFT substudy, all patients must be randomised to the SOFT (ACTRN12605000416695) parent trial.

The SOFT trial is a phase III trial evaluating the role of ovarian function suppression and the role of
exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer. Patients participating in the SOFT trial will be randomised to receive five years
of tamoxifen (20mg orally daily), five years of tamoxifen (20mg orally daily) plus ovarian function suppression (via either GnRH analogue, surgical oophorectomy or ovarian irradiation) or five years of exemestane (25mg orally daily) plus ovarian function suppression (via either GnRH analogue, surgical oophorectomy or ovarian irradiation). The method of ovarian function suppression may be determined by the treating clinican/patient and may be altered during the five year period, if necessary.

Patients may subsequently be registered to the Co-SOFT substudy, investigating cognitive function for patients participating in the SOFT parent trial. Cognitive function will be measured with a computerised test battery (CogState) consisting of computerised card games. Self reported cognitive function, psychological distress and fatigue will also be assessed via three multiple response based questionnaires.
Intervention code [1] 2120 0
Other interventions
Comparator / control treatment
The primary objective of the Co-SOFT substudy will be to evaluate cognitive function of those patients randomised to receive 5 years of tamoxifen vs those patients randomised to receive 5 years of tamoxifen plus ovarian function suppression.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3395 0
The primary objective is to evaluate and compare changes in cognitive function over 1 year in premenopausal breast cancer patients who receive adjuvant tamoxifen with or without ovarian function suppression.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games.
Timepoint [1] 3395 0
Cognitive function will be assessed at baseline and then 1 year after randomisation to the parent SOFT trial.
Secondary outcome [1] 5630 0
To compare the effect of tamoxifen plus ovarian function suppression versus exemestane plus ovarian function suppression on cognitive function over 1 year.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games.
Timepoint [1] 5630 0
Cognitive function will be assessed at baseline and then 1 year after randomisation to the parent SOFT trial.
Secondary outcome [2] 5632 0
To compare the effect of tamoxifen alone versus exemestane plus ovarian function suppression on cognitive function over 1 year.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games.
Timepoint [2] 5632 0
Cognitive function will be assessed at baseline and then 1 year after randomisation to the parent SOFT trial.
Secondary outcome [3] 5633 0
To evaluate and compare changes in cognitive function over 5 years and 6 years between the 3 treatment groups (pending funding becoming available for the year 5 and 6 measures).

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games.
Timepoint [3] 5633 0
Cognitive function will be assessed at baseline and at 1 year, 5 years and 6 years following randomisation to the parent SOFT trial.
Secondary outcome [4] 5634 0
To explore the impact of receiving prior chemotherapy or not on changes in cognitive function.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games.
Timepoint [4] 5634 0
Cognitive function will be assessed at baseline and at 1 year, 5 years and 6 years following randomisation to the parent SOFT trial.
Secondary outcome [5] 5635 0
To explore the relationship between subjective and objective cognitive function.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games. Subjective cognitive function will be evaluated via multiple response based questionnaires completed by trial participants.
Timepoint [5] 5635 0
Cognitive function will be assessed at baseline and at 1 year, 5 years and 6 years following randomisation to the parent SOFT trial.
Secondary outcome [6] 5636 0
To explore the relationship between cognitive function, psychological distress, fatigue, insomnia and quality of life.

Cognitive Function will be measured with a computerised test battery (CogState) consisting of computerised card games. Psychological distress, fatigue and insomnia will be evaluated via self completed multiple-response based questionnaires.

Quality of life will be assessed via self completed mulitple choice questionnaires administered as part of the parent SOFT trial.
Timepoint [6] 5636 0
Cognitive function, psychological distress, fatigue and insomnia will be assessed at baseline and at 1 year, 5 years and 6 years following randomisation to the parent SOFT trial.

Quality of life will be assessed at baseline and every 6 months during participation in the SOFT trial (until 6 years from the date of randomisation to SOFT).

Eligibility
Key inclusion criteria
All patients must be randomised to the parent SOFT trial but not yet started protocol hormonal therapy; Patients must not have received any adjuvant endocrine therapy either before or after randomisation to the SOFT trial; Patients must be able to speak and read English fluently; Informed consent must be obtained prior to registration.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who commenced adjuvant endocrine therapy prior to randomisation to the SOFT parent trial are not eligible to participate in the Co-SOFT substudy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patients will be randomised to the parent SOFT trial via computer generated stratified blocks. SOFT patients opting to participate in the Co-SOFT substudy will then be registered to participate in the trial.
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
28/10/2008
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
357
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 608 0
New Zealand
State/province [1] 608 0

Funding & Sponsors
Funding source category [1] 2649 0
Government body
Name [1] 2649 0
National Health and Medical Research Council
Country [1] 2649 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 2398 0
Other Collaborative groups
Name [1] 2398 0
International Breast Cancer Study Group
Address [1] 2398 0
IBCSG Coordinating Centre
Effingerstrasse 40
CH-3008
BERN
Country [1] 2398 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4568 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 4568 0
Ethics committee country [1] 4568 0
Australia
Date submitted for ethics approval [1] 4568 0
Approval date [1] 4568 0
19/03/2007
Ethics approval number [1] 4568 0

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

Contacts
Principal investigator
Name 28070 0
A/Prof Prue Francis
Address 28070 0
Medical Oncology Department
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
MELBOURNE VIC 8006
Country 28070 0
Australia
Phone 28070 0
+61 (03) 8559-7902
Fax 28070 0
Email 28070 0
Prue.Francis@petermac.org
Contact person for public queries
Name 11227 0
Corinna Beckmore
Address 11227 0
BCT
PO Box 283
The Junction NSW 2291
Country 11227 0
Australia
Phone 11227 0
+61 2 4925 5235
Fax 11227 0
+61 2 4925 3068
Email 11227 0
corinna.beckmore@bctrials.org.au
Contact person for scientific queries
Name 2155 0
Prue Francis
Address 2155 0
Medical Oncology Department
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
MELBOURNE VIC 8006
Country 2155 0
Australia
Phone 2155 0
+61 (03) 8559-7902
Fax 2155 0
+61 (03) 8559-7739
Email 2155 0
Prue.Francis@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an internationally-led trial and will depend on the international sponsor.


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.