Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000027213
Ethics application status
Approved
Date submitted
27/06/2008
Date registered
16/01/2009
Date last updated
27/11/2015
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
Nil
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
Breast

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
No
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
28/11/2008
Date of last participant enrolment
Anticipated
Actual
26/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
111
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3967 0
Government body
Name [1] 3967 0
Victorian Cancer Agency: Supportive Care Scholarships
Country [1] 3967 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne, Victoria, 3000
Country
Australia
Secondary sponsor category [1] 3557 0
University
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 6042 0
Approval date [1] 6042 0
02/10/2008
Ethics approval number [1] 6042 0
08-36

Summary
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
Nil
Public notes

Contacts
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
Australia
Phone 28705 0
+61 3 9656 1111
Fax 28705 0
Email 28705 0
[email protected]
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
Australia
Phone 11862 0
03 96561003
Fax 11862 0
03 96561095
Email 11862 0
[email protected]
Contact person for scientific queries
Name 2790 0
Dr [email protected]
Address 2790 0
Dept Clinical Psychology
Peter MacCallum Cancer Centre
Locked Bag 1 A Becket Street GPO
Melbourne Victoria 3000
Country 2790 0
Australia
Phone 2790 0
03 96561003
Fax 2790 0
03 96561095
Email 2790 0
[email protected]

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.