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Trial registered on ANZCTR


Registration number
ACTRN12611001061921
Ethics application status
Approved
Date submitted
11/10/2011
Date registered
11/10/2011
Date last updated
3/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Move More for Life: A tailored physical activity program for Australian breast cancer survivors
Scientific title
Move More for Life Study: Evaluating the efficacy of two theory-based print interventions promoting physical activity adoption and maintenance in Australian breast cancer survivors.
Secondary ID [1] 253040 0
Nil Known
Universal Trial Number (UTN)
U1111-1117-8005
Trial acronym
MM4L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 258603 0
Sedentary behaviour 278942 0
Physical inactivity 278943 0
Condition category
Condition code
Public Health 258747 258747 0 0
Health promotion/education
Cancer 279126 279126 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1- Theory-based Tailored-print intervention

Participants randomised into this condition will be mailed three theory-based computer-tailored newsletters over a 12 week period. Each newsletter will provide advice and feedback unique to the individual that relates to key determinants of physical activity adoption and maintenance among breast cancer survivors (as stipulated by previous research in the field and Social Cognitive Theory). The advice participants receive will be tailored using information derived from individual assessments at baseline, 4 weeks and 8 weeks post-baseline (materials will be iteratively tailored). In each case, participants will be mailed the tailored-newsletters immediately after the completed assessment is received.

Arm 2 - Theory-based Targeted-print intervention

Participants randomised into this group will receive a copy of a theory-based exercise guidebook developed specifically for promoting physical activity among breast cancer survivors. The guidebook is based on the Theory of Planned Behaviour and includes a 12 week walking program.
Intervention code [1] 257566 0
Behaviour
Intervention code [2] 257567 0
Lifestyle
Comparator / control treatment
Standard recommendation control group
Participants randomised into this condition will receive the “An active way to better health” brochure published by the Australian government, detailing the national physical activity guidelines for adults. A copy of the brochure can be downloaded free of charge from www.healthyactive.gov.au
Control group
Active

Outcomes
Primary outcome [1] 259610 0
The primary outcome variables, minutes of PA (aerobic and resistance) per week will be assessed using an adapted version (Liebreich, Plotnikoff et al. 2009) of the validated Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Godin and Shepard 1997).

The adapted version will incorporate a resistance training (RT) measure (Plotnikoff, Taylor et al. 2006; Liebreich, Plotnikoff et al. 2009) that asks participants to report the frequency (times per week) and duration (average times per session) of resistance training activities on average over the last month
Timepoint [1] 259610 0
Baseline, 4months and 10months post baseline
Secondary outcome [1] 266250 0
self-reported sitting time

Assessed using the self-reported sitting time questionnaire (Marshall et al, 2009)
Timepoint [1] 266250 0
Baseline, 4months and 10months post baseline
Secondary outcome [2] 266251 0
Steps per day

Assessed using digiwalker pedometers and diary
Timepoint [2] 266251 0
Baseline, 4months and 10months post baseline
Secondary outcome [3] 266252 0
Adherence to PA guidelines

Participants will be categorised as "inactive" (not doing any activity), "insufficiently active (not meeting the guidelines)" or "sufficiently active (meeting the guidelines)" based on wheather they meet the physical activity guidelines (outlined by Hayes, Spence et al. 2009).
Timepoint [3] 266252 0
Baseline, 4months and 10months post baseline
Secondary outcome [4] 266253 0
Adverse events due to physical activity

Assessed by 6-items asking participants to rate if they have experienced a problem due to engaging in physical activity in the last month on a five point likert scale ranging from not at all (1) to very much (5) .

An example item is
I have experienced an exercise related injury.
Timepoint [4] 266253 0
Baseline, 4months and 10months post baseline
Secondary outcome [5] 266254 0
Health-related quality of life

Assessed with the 37-item Functional Assessment of Cancer Therapy-Breast (FACT-B; Brady et al., 1997), which uses the sum of 5-point Likert scales to determine physical well-being, social well-being, emotional well-being, functional well-being, and additional concerns.
Timepoint [5] 266254 0
Baseline, 4months and 10months post baseline
Secondary outcome [6] 266255 0
Cancer-related fatigue

Assessed using the 13-item FACT-Fatigue (FACT-F) scale (Yellen et al., 1997).
Timepoint [6] 266255 0
Baseline, 4months and 10months post baseline
Secondary outcome [7] 266256 0
Proposed mediators (i.e. SCT constructs) will also be assessed using previously published, validated instruments where available.

Outcome expectations will be measured using 6- items from previous studies (Courneya and Friedenreich 1999; Plotnikoff, Blanchard et al. 2001; Plotnikoff, Lippke et al. 2008) and an addition 5-items developed for this study based on formative research among breast cancer survivors (Rogers, Matevey et al. 2004), including our own qualitative research and discussions with experts in the field. The response scale consists of a 5-point agreement scale (1=strongly disagree; 2 = disagree; 3 = not sure; 4 = agree; 5 = strongly agree).

Expectancies will be assessed by asking participants to rate how important each of the outcome expectations are to them (e.g. How important is preventing a cancer recurrent to you) on a 3-point scale (1 = unimportant/it?s ; 2 important; 3 very important).

Task self-efficacy will be assessed using 4-items developed (Rogers, Shah et al. 2005) and evaluated (Rogers, Courneya et al. 2006) in previous studies with breast cancer survivors and 3 additional items developed for this study to assess task-self efficacy for resistance-training activities (e.g. I can do two small sessions a week of resistance training). Participants will be asked to rate their confidence in their ability to perform a variety of tasks (e.g walk 20 minutes without stopping) on a scale from 1 to not at all confident to 5- extremely confident.

Barrier self-efficacy was assessed using 12 items based on previous scales used in chronic disease populations (Plotnikoff, Blanchard et al. 2001; Rogers, Courneya et al. 2006; Plotnikoff, Lippke et al. 2008) and unpublished qualitative data (2-items). Participants were asked how confident they were that they could engage in PA when faced by a range of barriers (e.g. when you lack discipline to exercise). The same scale was used for barrier self-efficacy as for task self-efficacy.

Behavioural capability, will be assessed using 6-items developed for this study. Participants were asked to rate on a 5-point likert scale (ranging from 1 strongly disagree to 5 strongly agree) how much they agree with the statement that they are knowledgeable about how to warm up and cool down and about what intensity, duration and type of activity they should do to gain health benefits. Participants were also asked to rate if they agreed that they have the skills to engage in aerobic and resistance-based activities . An example item is "I have the skills I need to engagin in resistance-based activities"

Self-regulation will be assessed using a 12-item measure developed by Umstattd et al (2009). Participants will be asked to rate how often they used each self-regulation strategy in the past 4 weeks on a scale from 1 to 5 (never, rarely, sometimes, often, very often). A sample item includes I rearranged my schedule to ensure I had time for PA

Action planning will be assessed using 4-items developed by Rise et al, and adapted by Rhodes et al to say physical activity instead of exercise. A sample question from this 4-item scale includes
I have made plans concerning when I am going to engage in regular physical activity over the next 2 weeks. All items were asked using a 5-point scale ranging from 1 (no plans) to 5 (detailed plans).

Social support will be assessed using the 15-item social support for exercise habits scale (Sallis, Grossman et al. 1987). Participants were asked to rate how often during the past three months their friends and family (separately) supported them/discouraged them to exercise in a variety of ways. Response options ranged from 1-none to 5 very often and an N/A option was also available. Example item: Gave me encouragement to stick with my exercise program
Timepoint [7] 266256 0
Baseline, 4months and 10months post baseline

Eligibility
Key inclusion criteria
Aged 18 years or older
Female
Have previously been diagnosed with breast cancer at any time point
Proficient in the English language to read intervention materials and complete surveys
Residing within Australia
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
At time of program commencement still undergoing active treatment (i.e. chemotherapy, radiotherapy, surgery)
If advised by a health professional that they are unable to partake in physical activity at a level equivalent to a 10 minute walk at a light pace.

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)
Breast cancer survivocipants will be required to return the signed consent form to the research team. Returned consent forms will be allocated a studrs interested in participating in the study will contact the researchers. Potential participants will be sent a study information pack, including an information sheet, consent form and a physical activity readiness questionnaire, via email or via the post. To enrol in the study potential partiy ID number in order to de-identify participants. Once concent is obtained, participants will be randomised into one of the study conditions. To ensure concealment, the random allocation sequence will be generated by a statisticain and given to the project manager. Randomisation will be completed by a research assistant who is not involved in the assessment of participants. As randomisation will occur using the study IDs only, the identify of potential participants will be unknown to those involved in allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not 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
Active, not 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)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS

Funding & Sponsors
Funding source category [1] 258020 0
Charities/Societies/Foundations
Name [1] 258020 0
Cancer Institute NSW
Address [1] 258020 0
Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
Australia.
Country [1] 258020 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan, NSW 2308
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 257214 0
None
Name [1] 257214 0
Address [1] 257214 0
Country [1] 257214 0
Other collaborator category [1] 251734 0
Individual
Name [1] 251734 0
A/Prof Erica James
Address [1] 251734 0
School of Medicine and Public Health
Priority Research Centre for Health Behaviour
Level 3, David Maddison Building, University of Newcastle
University Drive,
Callaghan, NSW Australia 2308.
Country [1] 251734 0
Australia
Other collaborator category [2] 251735 0
Individual
Name [2] 251735 0
Prof Ron Plonikoff
Address [2] 251735 0
School of Education
Priority Research Centre for Physical Activity and Nutrition
Advanced Technology Centre
University of Newcastle,
University Drive,
Callaghan, NSW 2308
Country [2] 251735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260016 0
Human Research Ethics Committee, University of Newcastle
Ethics committee address [1] 260016 0
Human Research Ethics Committee
Research Office
East Wing, The Chancellery
The University of Newcastle
University Drive.
Callaghan NSW 2308
Australia
Ethics committee country [1] 260016 0
Australia
Date submitted for ethics approval [1] 260016 0
12/05/2010
Approval date [1] 260016 0
07/07/2010
Ethics approval number [1] 260016 0
H-2010-1103
Ethics committee name [2] 271972 0
Hunter New England Research Ethics & Governance Unit
Ethics committee address [2] 271972 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [2] 271972 0
Australia
Date submitted for ethics approval [2] 271972 0
03/05/2011
Approval date [2] 271972 0
10/05/2011
Ethics approval number [2] 271972 0
N/A access request form approved.

Summary
Brief summary
This study aims to evaluate the feasibility and efficacy of two print-based interventions for increasing physical activity in Australian breast cancer survivors. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or more who has previously been diagnosed with breast cancer at any time point. You must not be undergoing active treatment at the commencement of this study (i.e. chemotherapy, radiotherapy, surgery). Trial details Participants in this trial will be randomly (by chance) allocated to one of three groups. Participants in group one will be mailed three theory-based computer-tailored newsletters over a 12 week period. Each newsletter will provide advice and feedback unique to the individual that relates to key determinants of physical activity adoption and maintenance among breast cancer survivors. Participants in group two will receive a copy of a theory-based exercise guidebook developed specifically for promoting physical activity among breast cancer survivors. Participants in group three will be provided with brochure outlining the physical activity guidelines for Australian adults. Participants will be assessed at baseline, 4 months and 10 months to determine physical activity levels, quality of life, safety and individual expectations and barriers.
Trial website
Trial related presentations / publications
Publications:
Short C, James E, Plotnikoff R, Girgis A (2011). Efficacy of tailored-print interventions to promote physical activity: A systematic review of randomised trials. IJBNPA. Accepted for publication 28/09/11

Presentations:
Short C, James E, Plotnikoff R. (2011). How theory-directed questions can help us understand physical activity behaviour in female breast cancer survivors (poster). 2011 Annual Conference of the International Society of Behavioural Nutrition and Physical Activity, Melbourne, Australia, 16-18 June 2011.

Short C, James E, Plotnikoff R, Girgis A. Efficacy of tailored-print interventions to promote physical activity: a systematic review of randomised trials (poster). 2011 Annual Conference of the International Society of Behavioural Nutrition and Physical Activity, Melbourne, Australia, 16-18 June 2011.


Short C, James E, Girgis A. Tailored lifestyles programs: A `how to' guide for researchers and health professionals. The annual IPOS World Congress of Psycho-Oncology, Vienna, Austria, 21-25 June 2009.

Short C, James E, Girgis A. Tailoring to promote physical activity and broken sedentary time amongst chronic disease populations. 2009 Annual Conference of the International Society of Behavioural Nutrition and Physical Activity, Lisbon, Portugal, 18-21 June 2009.

Short, C., James E, Girgis A. Tailoring to promote physical activity in breast cancer survivors. 10th Behavioural Research in Cancer Control Conference 'Behavioural research leading chronic disease control', Fremantle, 14-16 April 2010.
Public notes

Contacts
Principal investigator
Name 31883 0
Address 31883 0
Country 31883 0
Phone 31883 0
Fax 31883 0
Email 31883 0
Contact person for public queries
Name 15130 0
Camille Short
Address 15130 0
Postal address:
Priority Research Centre for Health Behaviour
University of Newcastle
Room 230A, Level 2, David Maddison Building
Callaghan NSW 2308 Australia

Street address:
Priority Research Centre for Health Behaviour
Room 230A, Level 2, David Maddison Building
Cnr King & Watt Sts
Newcastle 2300
The University of Newcastle
AUSTRALIA
Country 15130 0
Australia
Phone 15130 0
+ 61 2 49138617
Fax 15130 0
Email 15130 0
Camille.short@newcastle.edu.au
Contact person for scientific queries
Name 6058 0
Camille Short
Address 6058 0
Postal address:
Priority Research Centre for Health Behaviour
University of Newcastle
Room 230A, Level 2, David Maddison Building
Callaghan NSW 2308 Australia

Street address:
Priority Research Centre for Health Behaviour
Room 230A, Level 2, David Maddison Building
Cnr King & Watt Sts
Newcastle 2300
The University of Newcastle
AUSTRALIA
Country 6058 0
Australia
Phone 6058 0
+ 61 2 49138617
Fax 6058 0
Email 6058 0
Camille.short@newcastle.edu.au

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