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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The breast cancer survivors healthy lifestyle study: A randomised controlled trial to test the effects of information and advice on increasing healthy lifestyle behaviour change in breast cancer survivors
Scientific title
A randomised controlled trial of an exercise behaviour intervention to promote adoption of, and adherence to, exercise behaviours in breast cancer survivors
Secondary ID [1] 779 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 4182 0
Condition category
Condition code
Cancer 4392 4392 0 0

Study type
Description of intervention(s) / exposure
Behaviour change theory - Theory of planned behaviour and implementation intentions.
Experimental group 1 will receive a Theory Based Information booklet plus the behavioural intervention (prompt sheets to assist formation of an implementation intention); 1 session at baseline, time = 60 minutes) plus a pedometer and walking diary.
Experimental group 2 will receive a Theory Based Information booklet plus a pedometer and a walking diary, 1 session at baseline, time = (45 minutes). Both experimental groups will complete study measures at baseline, 12 week and 12 months.
Intervention code [1] 3901 0
Comparator / control treatment
Control group is usual care - this group receives an information fact sheet about maintaining a healthy lifestyle. Participants attend a baseline session (45 minutes) and complete study measures and will complete follow up sessions at 12 weeks and 12 months.
Control group

Primary outcome [1] 5270 0
Physical Activity: Self reported minutes of moderate to strenuous physical activity per week
Timepoint [1] 5270 0
Baseline, twelve weeks, twelve months
Secondary outcome [1] 8204 0
Mood: Beck Depression Inventory
Timepoint [1] 8204 0
Baseline, 12 weeks, 12 months
Secondary outcome [2] 8206 0
Quality of life - FACT- B
Timepoint [2] 8206 0
Baseline, 12 weeks and 12 months
Secondary outcome [3] 8882 0
Quality of Life FACT-B
Timepoint [3] 8882 0
Baseline, twelve weeks, twelve months

Key inclusion criteria
Diagnosis of breast cancer (Stage I – IIIa including Ductal carcinoma in situ);
completion of primary treatment (surgery radiation and or chemotherapy) within past one to twelve months
Health status - assessed by self and /or medical oncologist as eligible to participate
Minimum age
18 Years
Maximum age
75 Years
Can healthy volunteers participate?
Key exclusion criteria
Known contraindications for exercise (assessed by patient)
Physical/Psychiatric impairments that would impair mobility
Women already meeting exercise guidelines (defined for this study as greater than 150 minutes per week {Australian Government, Accessed March 2008 #225}

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistical package for Social Sciences (SPSS v15) uniform random number generator will be used to create a random ordered list of numbers from 1-120.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3967 0
Government body
Name [1] 3967 0
Victorian Cancer Agency: Supportive Care Scholarships
Address [1] 3967 0
Victorian Cancer Agency
Department of Human Services
Drummond Dtreet
Carlton VIC 3065
Country [1] 3967 0
Primary sponsor type
Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne, Victoria, 3000
Secondary sponsor category [1] 3557 0
Name [1] 3557 0
School of Behavioural Sciences
Address [1] 3557 0
School of Behavioural Sciences
Faculty of Medicine Dentistry and Heath Sciences University of Melbourne
Grattan Street Parkville VIC 3065
Country [1] 3557 0

Ethics approval
Ethics application status
Ethics committee name [1] 6042 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 6042 0
Ethics Secretariat
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne Victoria 3000
Ethics committee country [1] 6042 0
Date submitted for ethics approval [1] 6042 0
Approval date [1] 6042 0
Ethics approval number [1] 6042 0

Brief summary
The proposed study is a randomized controlled trial which aims to investigate how best to facilitate behaviour change regarding physical activity (defined as recreational exercise behaviours) in women who have completed primary treatment for early stage breast cancer.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28705 0
Dr Annabel Pollard
Address 28705 0
Dept Clinical Psychology
Locked bag 1
A'Beckett St GPO
Melbourne VIC 3000
Country 28705 0
Phone 28705 0
+61 3 9656 1111
Fax 28705 0
Email 28705 0
Contact person for public queries
Name 11862 0
Dr Annabel Pollard
Address 11862 0
Dept Clinical Psychology
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne Victoria 3000
Country 11862 0
Phone 11862 0
03 96561003
Fax 11862 0
03 96561095
Email 11862 0
Contact person for scientific queries
Name 2790 0
Address 2790 0
Dept Clinical Psychology
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne Victoria 3000
Country 2790 0
Phone 2790 0
03 96561003
Fax 2790 0
03 96561095
Email 2790 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary