Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000591550
Ethics application status
Approved
Date submitted
24/04/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Bridging the gap in physical activity and diet support for breast cancer survivors in Australia: a randomised controlled trial in primary care
Scientific title
Bridging the gap in physical activity and diet support for breast cancer survivors in Australia: a randomised controlled trial in primary care
Secondary ID [1] 311964 0
Nil
Universal Trial Number (UTN)
U1111-1307-3454
Trial acronym
EMPOWER-SMS GP RCT
Linked study record
ACTRN12618002020268 is a pilot trial of the EMPOWER-SMS program in a breast cancer institute in a public hospital. The current larger multi-centre trial is in primary care.

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 333566 0
Condition category
Condition code
Cancer 330248 330248 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive usual care, plus a six-month text message support program which delivers four to five text messages per week regarding physical activity, healthy diet, mental health, medication adherence and side effects management, general breast cancer information and weblinks to additional science-based information and free resources.. The message content was adapted from the EMPOWER-SMS pilot RCT and implementation study based on feedback from >500 Australian breast cancer survivors. The message content is based on behaviour change theories and was co-designed by consumer representatives, health professionals and researchers. The messages are positively toned, semi-personalised with the participant’s preferred name, and designed to be appropriate for individuals with a Grade 7 (Flesch Kincaid) reading level. Participants can reply, but it is not mandatory, and can opt-out by replying ‘STOP’. An unblinded clinical research team member will monitor replies for safety and respond if needed including requests to withdraw.
Intervention code [1] 328423 0
Lifestyle
Intervention code [2] 328518 0
Behaviour
Intervention code [3] 328519 0
Rehabilitation
Comparator / control treatment
The control group will continue to receive usual care from their assigned health professionals, including pharmacotherapy and lifestyle counselling according to their usual doctors and access to breast care nurses and other allied health professionals. The control group will also receive an initial text message welcoming them to the study, and follow-up text messages at 6-, 12-, 18- and 24* months (*if funding and time allows) containing a link to complete study surveys. At the end of the study, participants will be offered to receive the EMPOWER-SMS intervention free-of-charge, if they wish.
Control group
Active

Outcomes
Primary outcome [1] 338085 0
Between-group (intervention vs control) difference in mean MET-mins/day
Timepoint [1] 338085 0
Baseline and 6-months after randomisation (primary timepoint)
Secondary outcome [1] 434452 0
Between-group (intervention: control) differences at 6-months in the proportion (%) of participants meeting >=600 MET-mins MVPA/week
Timepoint [1] 434452 0
Baseline and 6 months after randomisation
Secondary outcome [2] 434453 0
Between-group (intervention: control) differences in proportion (%) of participants achieving >=300 MET-mins MVPA/week
Timepoint [2] 434453 0
Baseline and 6 months after randomisation
Secondary outcome [3] 434454 0
Between-group (intervention vs control) difference in the proportion (%) of participants meeting both >=600 MET-mins MVPA/week AND >=5 servings of vegetable per day
Timepoint [3] 434454 0
Baseline and 6 months after randomisation
Secondary outcome [4] 434455 0
Between-group differences in mean self-reported physical activity
Timepoint [4] 434455 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [5] 434456 0
Between-group differences in the proportion of participants meeting national physical activity guidelines (>=150 minutes of moderate physical activity or >=75 minutes of vigorous activity)
Timepoint [5] 434456 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [6] 434457 0
Between-group differences in the where proportion (%) of participants meeting Australian dietary guidelines or clinically meaningful targets will be measured using, including >=5 servings of vegetables per day, >=3 servings of vegetables per day, >=2 servings of fruit per day, <=7 servings (455g cooked or 700g raw) of red meat per week, >=2 servings of fish per week and drinking <=7 (women) or <=14 (men) standard alcoholic drinks per week
Timepoint [6] 434457 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [7] 434458 0
Between-group differences in quality of life (QOL)
Timepoint [7] 434458 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [8] 434459 0
Between-group differences in distress, mean and proportion achieving <4/10
Timepoint [8] 434459 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [9] 434460 0
Between-group differences in financial distress
Timepoint [9] 434460 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [10] 434461 0
Between-group differences in Fear of Cancer Recurrence, mean and proportion achieving <5 FCR
Timepoint [10] 434461 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [11] 434462 0
Between-group differences in proportion of participants who are adherent to endocrine therapy (missing <=1 tablet per week)
Timepoint [11] 434462 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [12] 434463 0
Between-group differences in Body Mass Index (BMI; kg/m2), mean and and proportion meeting a ‘healthy’ BMI (18.5-24.9 kg/m2).
Timepoint [12] 434463 0
Baseline, 6, 12, 18 and 24* months after randomisation *if funding and time allow
Secondary outcome [13] 434464 0
Between-group differences in cancer recurrence rate
Timepoint [13] 434464 0
6, 12, 18 and 24* months after randomisation *if funding and time allow

Eligibility
Key inclusion criteria
Any gender, adults aged 18 years or older, diagnosed with early-stage (0-III) breast cancer, completed active treatment including surgery, chemotherapy and/or radiation therapy within the past 3 years, own a mobile phone and attended at least 1 appointment at a participating primary care practice within the past 24-months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with an unsuitable diagnosis, for example distant metastatic breast cancer, are already participating in a text message or health behaviour-focused research study or are unable to comply with study requirements, including wearing an activity tracker and safely participating in physical activity or eating vegetables (not limited for medical reasons).

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)
Allocation will be concealed using a secured computer-based randomisation program (1:1 allocation ratio), which will produce group name pseudonyms, like ‘Group A’ and ‘Group B’ and trigger delivery of a text message to off-site participants disclosing their group allocation (EMPOWER-SMS GP intervention or control). Therefore, study personnel managing data collection and the statistician conducting outcome assessments will be blinded to group allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated using a computer program (SAS, v9.4; 1:1 blinded allocation, random permuted block sizes of 4 and 6) by an independent statistician.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will follow intention-to-treat and a pre-specified Statistical Analysis Plan (SAP) led by our blinded statistician, using SAS v9.4 and tests will be two-tailed. Categorical and continuous data will be summarised as frequencies and percentages or means and standard deviations, respectively. For the primary outcome, t-test will be used. As a sensitivity analysis, linear mixed effects regression model will be used to account for the practice clustering effect and baseline values of the primary outcome. Pre-specified sub-analysis will include urban vs. regional/remote, age, gender, health literacy level, and reported engagement (high vs. low engagement determined by user-survey). In case of non-negligible amounts of missing data (>10%), multiple imputation will be used under the missing at random assumption. For the secondary continuous and categorical outcomes, linear and logistic mixed effects regression models will be used, respectively, to account for the practice clustering effect and adjust for the outcome values at baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
678
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316306 0
Charities/Societies/Foundations
Name [1] 316306 0
Wereld Kanker Onderzoek Fonds (WKOF) as part of the World Cancer Research Fund International grant programme
Country [1] 316306 0
Belgium
Funding source category [2] 316391 0
Government body
Name [2] 316391 0
National Health and Medical Research Council of Australia
Country [2] 316391 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318570 0
None
Name [1] 318570 0
Nil
Address [1] 318570 0
Country [1] 318570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315124 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315124 0
Ethics committee country [1] 315124 0
Australia
Date submitted for ethics approval [1] 315124 0
12/01/2023
Approval date [1] 315124 0
28/04/2023
Ethics approval number [1] 315124 0
2023/081

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

Contacts
Principal investigator
Name 133738 0
Prof Julie Redfern
Address 133738 0
Engagement and Co-design Research Hub, School of Health Sciences Faculty of Medicine and Health, The University of Sydney Level 6, Block K, Westmead Hospital Westmead NSW 2145
Country 133738 0
Australia
Phone 133738 0
+61 28890 9214
Fax 133738 0
Email 133738 0
[email protected]
Contact person for public queries
Name 133739 0
Dr Anna Singleton
Address 133739 0
Engagement and Co-design Research Hub, School of Health Sciences Faculty of Medicine and Health, The University of Sydney Level 6, Block K, Westmead Hospital Westmead NSW 2145 Country
Country 133739 0
Australia
Phone 133739 0
+61479071675
Fax 133739 0
Email 133739 0
[email protected]
Contact person for scientific queries
Name 133740 0
Dr Anna Singleton
Address 133740 0
Engagement and Co-design Research Hub, School of Health Sciences Faculty of Medicine and Health, The University of Sydney Level 6, Block K, Westmead Hospital Westmead NSW 2145 Country
Country 133740 0
Australia
Phone 133740 0
+61479071675
Fax 133740 0
Email 133740 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
Ethics approval for this trial does not support data sharing.


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.