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Trial registered on ANZCTR


Registration number
ACTRN12618002020268
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
17/12/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A text message program to support women’s physical and mental health after breast cancer treatments
Scientific title
A text message intervention to support women’s self-efficacy and physical and mental health outcomes after breast cancer treatments (EMPOWER-SMS): a randomized controlled trial
Secondary ID [1] 296375 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMPOWER-SMS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 310117 0
Condition category
Condition code
Cancer 308867 308867 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a six-month text message support program in addition to usual care. Participants will receive four messages per week at random times and days for the duration of the program. Message topics include 1) general breast cancer information 2) social/emotional support, 3) diet/exercise and 4) medication adherence and side effects. The messages will be semi-personalised, where some contain the participant’s preferred name and are tailored for individual circumstances and preferences (eg. taking endocrine treatments or not). The messages are ‘one-way’, meaning that participants will not reply unless requesting withdrawal (‘STOP’). We have a purpose-built software system (software program and a centrally located research assistant with a clinical background) for safety monitoring of any replies and withdrawal (‘stop’) requests. A subset of participants (32/160) will wear accelerometers on their wrist for 7 days and resulting data will be used to validate the Global Physical Activity self-report scale.
Intervention code [1] 312710 0
Lifestyle
Comparator / control treatment
The control group will continue to receive usual care from their assigned health professionals, including access to breast care nurses, doctors and other allied health professionals. Participants in the usual care group will receive an initial text message welcoming them to the study, but they will not receive the text message support program. The control group will also receive a text-message reminder approximately six-months after their enrolment, notifying them that they will be contacted to schedule their six-month follow-up visit. Participants in the control group will be offered the opportunity to receive the intervention at the end of the study if they wish.
Control group
Active

Outcomes
Primary outcome [1] 307840 0
Self-efficacy, measured by Self-Efficacy for Managing Chronic Disease scale
Timepoint [1] 307840 0
6-months after randomisation
Secondary outcome [1] 353094 0
BMI measured by dividing weight in kilos using Seca medical Body Composition Analyser (mBCA) 515 with Seca and height in cm using a stadiometer
Timepoint [1] 353094 0
6-months after randomisation
Secondary outcome [2] 353095 0
total body fat percentage, assessed using Seca medical Body Composition Analyser (mBCA) 515 with Seca
Timepoint [2] 353095 0
6-months after randomisation
Secondary outcome [3] 353096 0
Physical activity measured by the Global Physical Activity Questionnaire and validated with portable accelerometers
Timepoint [3] 353096 0
6-months after randomisation
Secondary outcome [4] 353097 0
Nutrition, measured by World Health Organisation STEPwise approach to chronic disease risk factor surveillance
Timepoint [4] 353097 0
6-months after randomisation
Secondary outcome [5] 353098 0
Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core (EORTC QLQ-30)
Timepoint [5] 353098 0
6-months after randomisation
Secondary outcome [6] 353099 0
Quality of life measured by the European Organization for Research Breast Cancer subscale (EORTC QLQ-BR23)
Timepoint [6] 353099 0
6-months after randomisation
Secondary outcome [7] 353100 0
Depression and anxiety, measured by the short-form Depression Anxiety Stress Scale (DASS-21)
Timepoint [7] 353100 0
6-months after randomisation
Secondary outcome [8] 353101 0
Patient's illness perceptions, measured by Brief Illness Perception Questionnaire
Timepoint [8] 353101 0
6-months after randomisation

Eligibility
Key inclusion criteria
Patients will be eligible to participate if they are female, >18 years old; diagnosed with Breast Cancer; have completed breast cancer treatments (surgery, chemotherapy and/or radiation therapy) within the past 18 months (although can still be on endocrine treatment); own an operational mobile phone, capable of sending and receiving text messages; and provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they: are already participating in a text message-based study; have been diagnosed with distant metastatic breast cancer or cannot comply with study requirements (i.e. does not want to return for a follow-up visit).

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)
After the enrolment visit, participants will be randomly assigned to either usual care (control) or the text-message intervention group in a uniform 1:1 (control:intervention) allocation ratio, using a secured central computer-based randomisation service. For each participant, the computer system automatically produces a study identification number, which will be used on all study documents. Within three days after the enrolment visit, the computer system automatically sends the text message program to the participant. Therefore, the researcher conducting all face-to-face assessments remains blind to the study allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software with permuted blocks of 5 to minimise imbalances
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
To validate the self-reported physical activity questionnaire, 20% (32/160) of participants will receive a second layer of randomisation, where they will be randomly assigned to wear a small (matchbox sized) accelerometer for seven days and return it to a member of the research team. Randomisation will be nested within each treatment arm at a ratio of 1:4, with permuted blocks of 5 to minimise imbalances. Sixteen participants with accelerometers will be in the text message intervention group and 16 participants will be in the control group.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be performed according to the intention-to-treat principle. Continuous variables will be summarised as means and corresponding 95% confidence intervals (CIs), or if the distribution is skewed, as medians and interquartile intervals. Categorical variables will be summarised as frequencies and percentages. Primary outcome will be compared between the intervention and the control groups at 6-months using analysis of covariance (ANCOVA), adjusting for the baseline measure of the primary outcome. A backward selection process will be performed to identify additional covariates. Similarly, for each of the secondary outcomes, ANCOVA, adjusting for the baseline value of the outcome, will be used to compare between the groups at 6-months, unless assumptions are violated, or the outcome variable is categorical, in which case appropriate analyses will be performed adjusting for baseline values. We will also investigate if changes in secondary outcomes are mediated by self-efficacy scores. A significance level of 0.05 will be used. All analyses will be undertaken using SAS 9.4 for Windows.

Recruitment
Recruitment status
Not yet 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
Recruitment hospital [1] 12467 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 24768 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 300978 0
University
Name [1] 300978 0
University of Sydney
Address [1] 300978 0
University of Sydney at Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country [1] 300978 0
Australia
Primary sponsor type
University
Name
The University of Sydney, Westmead Clinical School
Address
University of Sydney at Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 300566 0
None
Name [1] 300566 0
N/A
Address [1] 300566 0
N/A
Country [1] 300566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301740 0
Western Sydney Local Health District HREC
Ethics committee address [1] 301740 0
Research Office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 301740 0
Australia
Date submitted for ethics approval [1] 301740 0
13/06/2018
Approval date [1] 301740 0
18/09/2018
Ethics approval number [1] 301740 0
AU RED HREC/18/WMEAD/281

Summary
Brief summary
The purpose of this study is to test if supportive text messages help improve women’s mental and physical health after breast cancer treatments compared to not receiving any messages.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer and have completed cancer treatments within the past 18 months.

Study details
Participants in this study will be randomised (by chance) into two groups. One group of participants will receive four text messages per week at random times and days in addition to their usual care for 6 months. The other group will receive usual care alone for the 6-month period, and will be offered the text message program after that time. A small percentage of participants from each group will also wear an accelerometer on their wrist for 7 days. All participants will complete a number of questionnaires before and after the 6-month period.

It is hoped this program will ease women’s transition to managing their health independently after treatments.
Trial website
N/A
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 87954 0
A/Prof Julie Redfern
Address 87954 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 87954 0
Australia
Phone 87954 0
+61 28890 9214
Fax 87954 0
Email 87954 0
Julie.redfern@sydney.edu.au
Contact person for public queries
Name 87955 0
Ms Anna Singleton
Address 87955 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 87955 0
Australia
Phone 87955 0
+61288908181
Fax 87955 0
Email 87955 0
anna.singleton@sydney.edu.au
Contact person for scientific queries
Name 87956 0
Ms Anna Singleton
Address 87956 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 87956 0
Australia
Phone 87956 0
+61288908181
Fax 87956 0
Email 87956 0
anna.singleton@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval for this trial does not support data sharing.
What supporting documents are/will be available?
No other documents available
Summary results
No Results