Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001220752
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
6/11/2013
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Date results provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among post-treatment breast cancer survivors.
Scientific title
Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among post-treatment breast cancer survivors.
Secondary ID [1] 283352 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
 290250 0
physical activity 290376 0
Condition category
Condition code
Cancer 290640 290640 0 0
Breast
Public Health 290767 290767 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive one of the following interventions:
(1) a computer-tailored single module intervention (participants are assessed and provided with a single round of feedback and advice); (2) a computer-tailored three module intervention delivered weekly (participants are assessed each week for two weeks and provided with iterative tailored feedback after each weekly assessment); and (3) a computer-tailored three module intervention delivered monthly (participants are assessed each month for two months and provided with iterative feedback after each monthly assessment).

For participants in the single module group - The advice participants receive will be delivered in a single module and will be tailored using information derived from individual assessments at baseline. Completion of the module will take approximately half an hour.

The advice will include information on the Australian physical activity (PA) guidelines for cancer survivors (non-tailored), tailored feedback on PA behaviour (aerobic, resistance) relative to the guidelines, information about the beneficial outcomes of PA, safety advice, expert advice from a behaviour change expert (non-tailored), a testimonial illustrating success, advice on eliciting social support, expert advice from an exercise physiologist (non-tailored), advice on restructuring the physical environment, information about available support services and an action planning activity.

For participants in the three module arms advice will be
tailored using information derived from individual assessments at baseline, and ‘short assessments’ (assessing physical activity and goal setting behaviour) completed at the start of module 2 and 3. Each module will take 15-20 minutes to complete.

Participants will receive similar information to participants in the single module group but information will be provided over three separate modules (instead of all at once) and also contain some feedback on progress over time.

For this group, module 1 will include information on the Australian PA guidelines for cancer survivors (non-tailored), tailored feedback on PA behaviour (aerobic, resistance and sitting time) relative to the guidelines, information about the beneficial outcomes of PA, safety advice and an action planning activity. Module 2 will include expert advice from a behaviour change expert (non-tailored), feedback on PA performance (aerobic, resistance and sitting time) relative to N1, a testimonial illustrating success, advice on eliciting social support and an action planning activity. Module 3 will include expert advice from an exercise physiologist (non-tailored), tailored feedback on PA performance (aerobic, resistance and sitting time) relative to N2 and N1, advice on restructuring the physical environment, information about available support services and an action planning activity.

Feedback in all modules is tailored primarily on demographic social-cognitive, behavioural and health status variables collected at baseline.


Intervention code [1] 288076 0
Behaviour
Comparator / control treatment
Single module intervention arm

This group receives a single module

The advice will include information on the Australian physical activity (PA) guidelines for cancer survivors (non-tailored), tailored feedback on PA behaviour (aerobic, resistance) relative to the guidelines, information about the beneficial outcomes of PA, safety advice, expert advice from a behaviour change expert (non-tailored), a testimonial illustrating success, advice on eliciting social support, expert advice from an exercise physiologist (non-tailored), advice on restructuring the physical environment, information about available support services and an action planning activity.
Control group
Active

Outcomes
Primary outcome [1] 290656 0
The primary outcome, change in physical activity (Moderate-Vigorous mins/week) at 3 months post baseline, will be assessed using an adapted version of the leisure score index (LSI) of the validated Godin Leisure-Time Exercise Questionnaire (GLTEQ). The adapted version of the LSI contains three items assessing participants average participation (frequency and duration) in mild, moderate and strenuous aerobic physical activity in a typical week over the past month.
Timepoint [1] 290656 0
3 months post-baseline
Secondary outcome [1] 304984 0
Change in physical activity at other time points

(change in physical activity at other time points will be assessed using an adapted version of the leisure score index (LSI) of the validated Godin Leisure-Time Exercise Questionnaire (GLTEQ). The adapted version of the LSI contains three items assessing participants average participation (frequency and duration) in mild, moderate and strenuous aerobic physical activity in a typical week over the past month).
Timepoint [1] 304984 0
1 month, 6 months
Secondary outcome [2] 304985 0
Quality of life (FACT-B)
Timepoint [2] 304985 0
3 months, 6 months
Secondary outcome [3] 305202 0
Change in resistance training activity

Resistance-training will be assessed using an adapted version of the leisure score index (LSI) of the validated Godin Leisure-Time Exercise Questionnaire (GLTEQ). The adapted version of the LSI contains a resistance training item that asks participants to report the frequency (times per week) and duration (average exercises and repetitions per session) of resistance training activities (i.e., lifting, pushing, pulling, and/or controlled lowering using machine weights, free weights, body weight or therabands) on average over the past month.
Timepoint [3] 305202 0
1 month, 3 months, and 6 months

Eligibility
Key inclusion criteria
To be eligible participants must:
Have previously been diagnosed with breast cancer (at any time point).
Have completed active cancer treatment (i.e., chemotherapy, radiotherapy, surgery).
Be proficient in the English Language in order to read content of the website and complete surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
To be eligible participants must not:
Have contraindications to exercise.
Participate in moderate-vigorous physical activity for 150 minutes or more per week.
Have previously participated in the Move More for Life Study (i.e., research project previously conducted by the research team).

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)
Participant will be asked to register for the study online, and complete a consent and eligibility form. Once this is completed the computer software supporting the website will automatically randomise participants into one of the three groups and direct them to the appropriate website.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
PA data, socio-cognitive and QOL measures will be analysed using Linear-mixed model (LMM) analyses. The primary analysis will be conducted using all observed data (i.e., a completers analysis) and sensitivity analyses (accounting for all randomised participants) using the baseline observations carried forward approach will be conducted to explore the impact of missing data.

To detect a medium standardized effect (d = 0.50) on our primary outcome (i.e., self-reported PA) with a power of 0.80 and a two-tailored alpha less than .05, we will need 63 survivors per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2013
Actual
24/06/2014
Date of last participant enrolment
Anticipated
Actual
30/08/2014
Date of last data collection
Anticipated
Actual
2/03/2015
Sample size
Target
190
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288081 0
Self funded/Unfunded
Name [1] 288081 0
Country [1] 288081 0
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Highway
Central Queensland University
Rockhampton QLD 4702
Country
Australia
Secondary sponsor category [1] 286805 0
None
Name [1] 286805 0
Address [1] 286805 0
Country [1] 286805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290008 0
CQ University's HUman Research Ethics Committee
Ethics committee address [1] 290008 0
Ethics committee country [1] 290008 0
Australia
Date submitted for ethics approval [1] 290008 0
15/07/2013
Approval date [1] 290008 0
13/08/2013
Ethics approval number [1] 290008 0
H13/07-126

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

Contacts
Principal investigator
Name 43442 0
Dr Camille Short
Address 43442 0
Building 18, room 1.30
Bruce Highway
CQU University
Rockhampton, QLD 4702
Country 43442 0
Australia
Phone 43442 0
61749232689
Fax 43442 0
Email 43442 0
[email protected]
Contact person for public queries
Name 43443 0
Camille Short
Address 43443 0
Building 18, room 1.30
Bruce Highway
CQU University
Rockhampton, QLD 4702
Country 43443 0
Australia
Phone 43443 0
61749232689
Fax 43443 0
Email 43443 0
[email protected]
Contact person for scientific queries
Name 43444 0
Camille Short
Address 43444 0
Building 18, room 1.30
Bruce Highway
CQU University
Rockhampton, QLD 4702
Country 43444 0
Australia
Phone 43444 0
61749232689
Fax 43444 0
Email 43444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in original ethics agreement. However, amendment can be sought if data request is made.
Please contact lead author for data requests. Additional information about the project is available on the study open science framework page.


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.