Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000175471
Ethics application status
Approved
Date submitted
28/01/2016
Date registered
11/02/2016
Date last updated
21/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using wearable technology activity monitors to increase physical activity and decrease sitting time amongst breast cancer survivors: the ACTIVity And TEchnology (ACTIVATE) Trial
Scientific title
Using wearable technology activity monitors to increase physical activity and decrease sitting time amongst breast cancer survivors: the ACTIVity And TEchnology (ACTIVATE) Trial
Secondary ID [1] 288438 0
Nil
Universal Trial Number (UTN)
U1111-1178-9881
Trial acronym
ACTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 297458 0
Sedentary behaviour 297459 0
Breast cancer 297460 0
Condition category
Condition code
Public Health 297650 297650 0 0
Epidemiology
Cancer 297706 297706 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- change of Study Coordinator (intervention now delivered by health coaches - staff with public health qualifications)
- physical function and cognitive function testing not administered
Intervention code [1] 293759 0
Treatment: Other
Intervention code [2] 293760 0
Lifestyle
Intervention code [3] 293761 0
Behaviour
Comparator / control treatment
Wait-list control arm. The wait-list control arm will receive the abridged version of the intervention after a 12 week wait period. The abridged version of the intervention includes only the initial information and training session; and the wearable technology activity monitor to wear for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 297186 0
Moderate-vigorous physical activity, assessed by acceleroemter over a one week period at T2.
Timepoint [1] 297186 0
Upon completion of primary intervention (T2; 12 weeks after commencement of intervention). Data to be collected over seven consecutive days of accelerometer wear.
Primary outcome [2] 297240 0
Sedentary behaviour, assessed by ActivPAL inclinometer over a one week period at T2
Timepoint [2] 297240 0
Upon completion of primary intervention (T2; 12 weeks after commencement of primary intervention). Data to be collected over seven consecutive days of inclinometer wear.
Secondary outcome [1] 320271 0
Maintenance of physical activity change approximately 12 weeks after conclusion of primary intervention (primary intervention group only). Change in physical activity assessed by data collected over a one week period by accelerometer at T3.
Timepoint [1] 320271 0
Upon completion of maintenance phase (12 weeks post T2). Acelerometer to be collected over seven consecutive days.
Secondary outcome [2] 320272 0
Efficacy of an abridged intervention (wait-list control group only) on physical activity assessed by accelerometer data collected over a one week period at T3. Within group change in physical activity between T2 and T3 examined.
Timepoint [2] 320272 0
On completion of abridged intervention phase at T3 (T3; 12 weeks post T2). Pre-post design employed for change analysis.
Secondary outcome [3] 320278 0
Tests of physical function no longer administered
Timepoint [3] 320278 0
Tests of physical function no longer administered
Secondary outcome [4] 320279 0
Tests of cognitive function no longer administered
Timepoint [4] 320279 0
Tests of cognitive function no longer administered
Secondary outcome [5] 320432 0
Maintenance of change in sitting time 12 weeks after conclusion of primary intervention (primary intervention group only). Sitting time assessed by data collected over a one week period by inclinometer at T3. Change score derived by subtracting T3 sitting time from T2.
Timepoint [5] 320432 0
Upon completion of maintenance phase (12 weeks post T2). ActivPAL inclinometer data to be collected over seven consecutive days.
Secondary outcome [6] 320433 0
Efficacy of an abridged intervention (wait-list control group only) on sitting time assessed by data collected over a one week period by inclinometer at T3. Pre-post design employed for change analysis.
Timepoint [6] 320433 0
On completion of abridged intervention phase at T3 (T3; 12 weeks post T2). Pre-post design employed for change analysis.

Eligibility
Key inclusion criteria
Post-menopausal breast cancer survivors, diagnosed with stage I-III breast cancer, who have completed primary treatment (surgery, chemotherapy, radiation therapy – ongoing hormone therapy is acceptable). Other eligibility criteria include: engaging in more than six hours of sitting each day; less than 75 minutes of moderate-vigorous physical activity per week; able to speak/write fluently in English; having daily access to a smart phone, mobile device or personal computer.
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-menopausal women. Women diagnosed with breast cancer still undergoing primary treatment. Those engaging in less than six hours of sitting each day; more than 75 minutes of moderate-vigorous physical activity per week.

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)
Initial telephone screening is conducted by the Study Coordinator. Eligible participants are sent a baseline sociodemographic questionnaire, accelerometer/inclinometer and consent form. If these baseline data collection measures are completed and returned, along with the consent form, to the study team, participants are then randomised by another team member who will have no personal contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the ‘ralloc’ Stata module.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A two-arm design of which part 1 is a traditional randomised control trial; part 2 combines a maintenance phase for the intervention participants of part 1 plus an abridged intervention phase for the control participants of part 1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised across the treatment groups. Should unexpected imbalances between the two groups occur by chance, they will be corrected in an adjusted analysis. To determine the effect of the intervention on both physical activity and sitting time, the trial analysis will be performed following the intention-to-treat principle. The analysis will therefore include all participants who were randomized (n=92) regardless of their compliance levels. Intervention effects will be assessed using linear mixed models for continuous variables. This model includes random effects associated with the units of analysis (participants), and allows the residuals associated with the longitudinal measures on the same unit of analysis to be correlated. This approach includes all available data at each time point, and may be adjusted for covariates if imbalances between groups are noted.
Linear mixed models will also be used to address the secondary aims of the study. Here, we will only consider the within-group change (aims 2 and 3 do not have a control condition). All analyses will be conducted using Stata statistical software version 12 (Statacorp, College Station, TX, USA).
Our sample size calculation is based on Aim 1: determining the efficacy of the primary intervention (use of wearable technology, coupled with brief behavioural counselling and goal setting) in increasing physical activity and reducing sitting time. The sample size for this study enables detection of a difference in physical activity between primary intervention and wait-list control groups at T2 of 75 minutes per week. Assuming a standard deviation of change of 120 minutes and allowing 10% attrition, 46 women per group (92 participants in total; 82 at end of intervention) will be needed to detect this minimum difference in total physical activity between groups with 80% power and a type I error of 5% (two-tailed). With a final sample size of 82 we will have 99% power to detect a difference of 75 minutes per day of sitting time between groups, assuming a standard deviation of change of 107 minutes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
29/07/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
30/06/2017
Date of last data collection
Anticipated
17/11/2017
Actual
11/01/2018
Sample size
Target
92
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292781 0
Charities/Societies/Foundations
Name [1] 292781 0
World Cancer Research Fund International
Country [1] 292781 0
United Kingdom
Funding source category [2] 292785 0
Charities/Societies/Foundations
Name [2] 292785 0
National Breast Cancer Foundation
Country [2] 292785 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Victoria
Address
615 St Kilda Road,
Melbourne,
Victoria,
3004,
Country
Australia
Secondary sponsor category [1] 291517 0
None
Name [1] 291517 0
Address [1] 291517 0
Country [1] 291517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294275 0
Human Research Ethics Committee (Cancer Council Victoria)
Ethics committee address [1] 294275 0
615 St Kilda Road,
Melbourne, Victoria, 3004,
Ethics committee country [1] 294275 0
Australia
Date submitted for ethics approval [1] 294275 0
22/01/2016
Approval date [1] 294275 0
21/03/2016
Ethics approval number [1] 294275 0

Summary
Brief summary
This study aims to determine whether using wearable technology activity monitors coupled with brief behavioural counselling and goal setting can increase physical activity and decrease sitting time amongst breast cancer survivors.
Who is it for?
You may be eligible to join this study if you are a post-menopausal breast cancer survivor who was diagnosed with stage I-III breast cancer, and who has completed primary treatment (ongoing hormone therapy is acceptable). Eligible participants will also engage in less than 75 minutes of moderate-vigorous physical activity per week, more than six hours of sitting each day.
Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a novel 12 week intervention which involves: 1) Attending an initial information and training session; 2) wearing a technology activity monitor daily to enable real-time monitoring of physical activity and sitting time; and 3) receiving five behavioural counselling and goal setting sessions via telephone. The intervention will be followed by a 12 week maintenance period. Participants in the other group will receive no intervention for the first 12 weeks. After this time they will attend an information and training session and wear the activity monitor for 12 weeks. They will not receive the behavioural counselling and goal setting sessions.
All participants will complete assessments by wearing an accelerometer and inclinometer at baseline, after 12 weeks, and after 24 weeks in order to evaluate physical activity and sitting time. The proposed intervention has the potential to be an inexpensive and sustainable addition to usual care provided by clinicians, allied health professionals or via telephone-delivered cancer information and support services (such as those delivered by Cancer Councils across Australia).
Trial website
http://www.cancervic.org.au/research/epidemiology/cecprograms/activate-trial.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63150 0
Dr Brigid Lynch
Address 63150 0
Cancer Council Victoria
615 St Kilda Road,
Melbourne,
Victoria,
3004,
Country 63150 0
Australia
Phone 63150 0
+61 3 9514 6209
Fax 63150 0
+61 3 9514 6800
Email 63150 0
[email protected]
Contact person for public queries
Name 63151 0
Dr Brigid Lynch
Address 63151 0
Cancer Council Victoria
615 St Kilda Road,
Melbourne,
Victoria,
3004,
Country 63151 0
Australia
Phone 63151 0
+61 3 9514 6209
Fax 63151 0
+61 3 9514 6800
Email 63151 0
[email protected]
Contact person for scientific queries
Name 63152 0
Dr Brigid Lynch
Address 63152 0
Cancer Council Victoria
615 St Kilda Road,
Melbourne,
Victoria,
3004,
Country 63152 0
Australia
Phone 63152 0
+61 3 9514 6109
Fax 63152 0
+61 3 9514 6800
Email 63152 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
SourceTitleYear of PublicationDOI
EmbaseStudy design and methods for the ACTIVity And TEchnology (ACTIVATE) trial.2018https://dx.doi.org/10.1016/j.cct.2017.10.015
N.B. These documents automatically identified may not have been verified by the study sponsor.