Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000954426
Ethics application status
Approved
Date submitted
16/07/2016
Date registered
20/07/2016
Date last updated
19/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and effect of using consumer-based physical activity monitors to improve exercise behaviour in women with Stage II+ breast cancer.
Scientific title
The feasibility and effect of using consumer-based physical activity monitors to improve exercise behaviour in women with Stage II+ breast cancer.
Secondary ID [1] 289695 0
Nil known
Universal Trial Number (UTN)
U1111-1185-4506
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 299499 0
Condition category
Condition code
Cancer 299486 299486 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve one face-to-face, 60-minute structured physical activity counselling session with an Accredited Exercise Physiologist (AEP), plus provision of a Fitbit physical activity monitor (Fitbit Charge HR, https://www.fitbit.com/au/chargehr) for 12-weeks. The physical activity counselling session will be one-on-one, and conducted at an exercise clinic by an AEP with experience in exercise prescription and supervision for women with stage II+ breast cancer. During this session, the AEP will use a patient-centred approach by following the Chronic Disease Self-Management Intervention Model to develop individualised physical activity goals that are consistent with National and International physical activity guidelines for women with breast cancer. During the 60-minute session, the AEP will lead each participant through a study-specific physical activity maintenance handbook that has been developed in accordance with the CDSM. Participants will be informed of current National and International physical activity guidelines for women with breast cancer provided to them in the study handbook and will discuss physical activity goal setting. Specifically, participants will be encouraged to: identify and discuss benefits associated with maintenance physical activity and exercise participation; identify expected benefits remaining physically active; identify forms of motivation to maintain long-term physical activity participation; identify barriers to physical activity participation and use a problem-solving approach to address barriers, and; develop individualised goals that are realistic and measurable. Participants will also be shown how to use the Fitbit physical activity monitor. Following completion of the 60-minute face-to-face physical activity counselling session, participants will use the Fitbit independently to self-monitor and self- manage their physical activity as desired during the 12-week period. Participants will be able to use and access the Fitbit and associated software as desired over the 12 weeks. Adherence to use of the Fitbit will be assessed by evaluating the total number of days and mean number of hours per day the device was worn (obtained via self-report). No additional AEP contact, physical activity counselling or structured sessions with the AEP during the 12-week period (i.e., after completion of the 60-minute physical activity session). Self-reported and objectively assessed physical activity levels will be assessed at baseline and 12-week.
Intervention code [1] 295320 0
Lifestyle
Intervention code [2] 295331 0
Behaviour
Intervention code [3] 295332 0
Treatment: Devices
Comparator / control treatment
The control group will involve one face-to-face, 60-minute structured physical activity counselling session with an Accredited Exercise Physiologist (AEP). The physical activity counselling session will be conducted at an exercise clinic by an AEP with experience in exercise prescription and supervision for women with stage II+ breast cancer. During this session, the AEP will use a patient-centered approach by following the Chronic Disease Self-Management Intervention Model to develop individualised physical activity goals that are consistent with National and International physical activity guidelines for women with breast cancer. During the 60-minute session, the AEP will lead each participant through a study-specific physical activity maintenance handbook that has been developed in accordance with the CDSM. Participants will be informed of current National and International physical activity guidelines for women with breast cancer provided to them in the study handbook and will discuss physical activity goal setting. Specifically, participants will be encouraged to: identify and discuss benefits associated with maintenance physical activity and exercise participation; identify expected benefits remaining physically active; identify forms of motivation to maintain long-term physical activity participation; identify barriers to physical activity participation and use a problem-solving approach to address barriers, and; develop individualised goals that are realistic and measurable. No additional AEP contact, physical activity counselling or structured sessions with the AEP during the 12-week period (i.e., after completion of the 60-minute physical activity session).
Control group
Active

Outcomes
Primary outcome [1] 298960 0
Moderate to vigorous physical activity (minutes per week). This will be assessed objectively using a Actigraph accelerometer (worn on the hip for 7 continuous days).
Timepoint [1] 298960 0
Assessed for one week at the 12 week timepoint.
Secondary outcome [1] 325765 0
Self-reported brisk walking (minutes per week). This will be evaluated using the Active Australia Survey.
Timepoint [1] 325765 0
Assessed for one week at the 12 week timepoint.

Eligibility
Key inclusion criteria
To be eligible, women need to be aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II+. The residence criterion will allow for the AEP to travel to participants’ homes for intervention sessions. All participants must be currently undergoing treatment, or recently completed treatment (within the past 24 months). Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently be insufficiently physical active (that is, engage in <150 minutes of moderate-intensity physical activity per week), plus meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one comorbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index > 25 kg/m2], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper-body morbidity, neuropathy, fatigue, arthralgia). Self-report of moderate- to severe-intensity treatment-sequelae, even in the absence of a clinical diagnosis will also be accecpted. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care. These self-report measures are ones that have been included in previous prospective cohort studies. These eligibility criterion will ensure the subgroup of the breast cancer population that have typically been excluded from previous study can participate. That is, this study aims to evaluate women with the characteristics of typical women with later-stage breast cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: being sufficiently active (that is, currently meet the National physical activity recommendations); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) or adjuvant treatment during the study period; unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
A total of 40 participants will be rectruited into the present study (20 per group). Based on a clinically meaningful difference in physical activity of 40 min/week and a standard deviation of 50 min/week, with 20 participants per group, the study will have 70% power to reject the null hypothesis. The success of randomisation will be evaluated during preliminary analyses. If imbalances between groups occur, they may be adjusted for in further analytical modelling. Intention-to-treat analyses will be used for efficacy analyses. Generalised estimating equation modelling will be used to assess group × time interactions. The primary outcome measure is change in self-report MVPA (min/wk) from baseline to 12-week follow-up. Secondary measures will include: change in self-report MVPA (number of days/wk); change in self-reported brisk walking (min/wk and number of days/wk), and; objectively assessed MVPA at 12-week follow-up (min/wk and number of 10-min bouts/wk). The main analysis of physical activity levels will be based on an intention-to-treat analysis, therefore all participants’ data will be analysed according to their randomised group regardless of Fitbit compliance. Summary descriptive statistics will be used to report baseline characteristics which will include means (SD) (or medians and ranges, depending on distribution), for continuous variables. Between-group differences in baseline characteristics will be adjusted for in primary and secondary analyses if required. Change in self-reported physical activity outcomes between baseline and 12-week follow-up will be analysed using Generalised estimating equation (GEE) modelling to assess change in physical activity overtime, and between-group differences. Objectively measured MVPA will be assessed by comparing between-group differences at 12 weeks using independent t-tests or Mann-Whitney test (for non-parametric data). Previous reports were used to determine a clinically relevant change over time in the primary outcome. For weekly MVPA, 40 min/week is considered a clinically meaningful change. Therefore, maintenance of physical activity participation will be considered a reduction in MVPA of < 40 min/week. As an exploratory analyses, feasibility of the Fitbit will be assessed by computing retention of those randomised to the Fitbit compared to the control group (with a 10% between-group difference considered clinically relevant) and compliance to using the Fitbit (with >75% considered acceptable).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2016
Actual
22/08/2016
Date of last participant enrolment
Anticipated
23/08/2017
Actual
23/08/2017
Date of last data collection
Anticipated
13/12/2017
Actual
13/12/2017
Sample size
Target
40
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6182 0
Mater Private Hospital - South Brisbane
Recruitment hospital [2] 6183 0
Holy Spirit Northside - Chermside
Recruitment hospital [3] 6184 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 13617 0
4101 - South Brisbane
Recruitment postcode(s) [2] 13618 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294074 0
University
Name [1] 294074 0
Queensland University of Technology
Country [1] 294074 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology, Victoria Park Road, Kelvin Grove QLD 4059 Australia
Country
Australia
Secondary sponsor category [1] 292905 0
None
Name [1] 292905 0
Address [1] 292905 0
Country [1] 292905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295488 0
Queensland University of Technology University Human Research Ethics Committee (UHREC)
Ethics committee address [1] 295488 0
Queensland University of Technology
School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology
Victoria Park Road, Kelvin Grove QLD 4059 Australia
Ethics committee country [1] 295488 0
Australia
Date submitted for ethics approval [1] 295488 0
22/06/2016
Approval date [1] 295488 0
07/07/2016
Ethics approval number [1] 295488 0
Approval Number: 1600000631

Summary
Brief summary
The primary purpose of this trial is to evaluate the feasibility and efficacy of using Fitbit devices in combination with an individual exercise counselling session to increase physical activity in women with stage II+ breast cancer.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or older, and have been diagnosed with stage II+ breast cancer for which you are either currently undergoing treatment, or have finished treatment within the previous 24 months. Participants must also reside or work in greater Brisbane and be insufficiently physically active.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either an individual exercise counselling session plus use of a Fitbit device for 12 weeks, or to receive only the individual exercise counselling session. The exercise counselling session will involve a 60 minute appointment at an exercise clinic (Queensland University of Technology, Brisbane) with an accredited exercise physiologist to discuss recommended physical activity levels and methods for increasing physical activity. Individuals in the Fitbit group will then be provided with a Fitbit device to use as much as they choose for the following 12 weeks. All participants will then have their physical activity levels assessed (by wearing a small physical activity monitor on their hip) and report on their levels of physical activity in order for researchers to compare between the two groups.

It is hoped that the findings from this study will inform physicians and patients on easily accessible, cost-effective and feasible approaches for maintaining physical activity participation in the absence of supervised exercise in breast cancer patients with a high disease burden.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67470 0
Prof Sandi Hayes
Address 67470 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 67470 0
Australia
Phone 67470 0
(+617) 3138 9645
Fax 67470 0
Email 67470 0
[email protected]
Contact person for public queries
Name 67471 0
Mr Ben Singh
Address 67471 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 67471 0
Australia
Phone 67471 0
(+617) 3138 3016
Fax 67471 0
Email 67471 0
[email protected]
Contact person for scientific queries
Name 67472 0
Mr Ben Singh
Address 67472 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 67472 0
Australia
Phone 67472 0
(+617) 3138 3016
Fax 67472 0
Email 67472 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
EmbaseFeasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer - A randomised controlled trial.2020https://dx.doi.org/10.1016/j.jsams.2019.09.019
N.B. These documents automatically identified may not have been verified by the study sponsor.