Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000448448p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Mobile Phone App to Help Breast Cancer Patients Navigate Treatment Choices
Scientific title
Development and Validation of a Mobile Decision-Support App for Personalized Breast Cancer Treatment Planning in newly diagnosed patients
Secondary ID [1] 314220 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 337137 0
Condition category
Condition code
Cancer 333560 333560 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single-arm, interventional pilot study evaluating the use of a mobile phone application designed to support treatment planning for newly diagnosed breast cancer patients. The intervention involves providing participants with access to a decision-support app that generates personalized treatment recommendations based on user-entered clinical and pathological data, including tumor size, location, receptor status (Estrogen Receptor [ER], Progesterone Receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2]), nodal involvement, and patient demographics.
Participants will use the app at the time of diagnosis or treatment planning, entering their own clinical information (with assistance from a study coordinator if needed). The app will generate a personalized summary, which includes:
• Suitability for breast-conserving surgery
• Likelihood of requiring sentinel lymph node biopsy or axillary dissection
• Likelihood of needing neoadjuvant chemotherapy ± trastuzumab
• Predicted sequence of treatment (e.g., neoadjuvant vs. upfront surgery)
• Likelihood of requiring adjuvant therapies (chemotherapy, radiotherapy, endocrine therapy)

This summary is provided solely for informational purposes to assist patients in understanding potential treatment options. The app does not provide medical advice or replace clinical judgment, and treatment decisions remain under the direction of the multidisciplinary team (MDT). The app’s outputs will be compared to actual MDT decisions to assess concordance.

As participants only receive access to the app and its outputs by enrolling in this study, this will be considered a non-interventional study. The application summary is intended for informational purposes only and is not used for direct decision-making alongside the MDT.

Study Duration and Frequency:
The app will be used once at the time of diagnosis or treatment planning, with an expected duration of approximately 30-60 minutes for data entry and review.

Strategies to Assess Adherence:
Adherence to the intervention will be assessed using app analytics, including usage rates, time spent on the app, and completion of modules.
Intervention code [1] 330842 0
Diagnosis / Prognosis
Comparator / control treatment
This study is a prospective interventional validation of a clinical decision-support tool. Participants will use a mobile application that generates personalized treatment recommendations, which will be compared against the treatment decisions made by the institution’s multidisciplinary team (MDT), representing the current standard of care.

The MDT decisions, guided by established clinical pathways and best practice guidelines (e.g., NCCN, ESMO, St Gallen), will serve as the reference standard for evaluating the predictive accuracy of the app.
Control group
Active

Outcomes
Primary outcome [1] 341137 0
Concordance between app-generated treatment recommendations and actual multidisciplinary team (MDT) treatment decisions
Timepoint [1] 341137 0
At initial treatment planning (following diagnosis, prior to first definitive therapy)
Secondary outcome [1] 446465 0
Usability
Timepoint [1] 446465 0
Immediately after app use
Secondary outcome [2] 446467 0
Confidence in treatment decisions
Timepoint [2] 446467 0
Before and after app interaction
Secondary outcome [3] 446468 0
Clinician feedback on the app’s clinical utility
Timepoint [3] 446468 0
During or at the end of study participation
Secondary outcome [4] 446469 0
Accuracy of app prediction for suitability for breast-conserving surgery
Timepoint [4] 446469 0
At time of MDT review
Secondary outcome [5] 447122 0
Acceptability
Timepoint [5] 447122 0
Immediately after app use
Secondary outcome [6] 447123 0
Understanding of treatment options
Timepoint [6] 447123 0
Before and after app interaction
Secondary outcome [7] 447134 0
Accuracy of app prediction for need for neoadjuvant chemotherapy
Timepoint [7] 447134 0
At time of MDT review
Secondary outcome [8] 447135 0
Accuracy of app prediction for suitability for adjuvant radiotherapy
Timepoint [8] 447135 0
At time of MDT review
Secondary outcome [9] 447137 0
Accuracy of app prediction for endocrine therapy recommendation
Timepoint [9] 447137 0
At time of MDT review
Secondary outcome [10] 447138 0
Accuracy of app prediction for HER2-targeted therapy recommendation
Timepoint [10] 447138 0
At time of MDT review
Secondary outcome [11] 447139 0
Accuracy of app prediction for chemotherapy recommendation
Timepoint [11] 447139 0
At time of MDT review

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria:

For patients:

Aged 18 years or older
Newly diagnosed with invasive breast cancer (any histologic subtype)
Planned for treatment with curative intent within a multidisciplinary team setting
Able to provide informed consent
Have access to a smartphone or tablet device
Able to read and understand English (or the language in which the app is available)

For clinicians:

Involved in the care of breast cancer patients within the participating multidisciplinary team
Have used or reviewed the decision-support app as part of the study
Willing and able to provide feedback through interviews or surveys
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria:

For patients:

Diagnosis of non-invasive breast cancer only (e.g., ductal carcinoma in situ [DCIS] without an invasive component)
Evidence of metastatic (stage IV) breast cancer at diagnosis
Enrolled in another clinical trial that could influence treatment planning
Cognitive impairment or other condition affecting the ability to use the app or provide informed consent
No access to mobile technology or a reliable internet connection
For clinicians:

There are no specific exclusion criteria for clinicians participating in the feedback component of the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis will assess concordance between treatment recommendations generated by the mobile decision-support app and actual decisions made by the multidisciplinary team (MDT).

Primary Analysis:
• Concordance will be assessed using:
• Percentage agreement (simple match rate between app prediction and MDT decision)
• Cohen’s kappa statistic to account for chance agreement
• This will be calculated separately for:
• Surgical approach (e.g., breast-conserving surgery vs. mastectomy)
• Axillary management (e.g., sentinel lymph node biopsy vs. axillary clearance)
• Use of neoadjuvant chemotherapy
• Adjuvant therapy components (chemotherapy, radiotherapy, endocrine therapy)

Secondary Analyses:
• Usability and patient-reported acceptability will be summarized using descriptive statistics (means, medians, proportions), and visualized using bar graphs or Likert distributions.
• Change in patient confidence/understanding pre- and post-app use will be assessed using paired t-tests or Wilcoxon signed-rank tests, depending on data normality.
• Clinician feedback will be analyzed descriptively and supplemented by thematic analysis for qualitative open-ended responses.
• Predictive accuracy of the app’s algorithm for individual treatment decisions will be evaluated using:
• Sensitivity
• Specificity
• Positive Predictive Value (PPV)
• Negative Predictive Value (NPV)

Sample Size Justification:

This is a pilot validation study, targeting ~100 patients. This sample size is expected to allow preliminary estimation of concordance rates with acceptable confidence intervals, and to inform future powered studies.

All statistical analyses will be performed using SPSS, Stata, or R, and a significance level of p < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27787 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 43976 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 318737 0
Self funded/Unfunded
Name [1] 318737 0
Country [1] 318737 0
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 321173 0
None
Name [1] 321173 0
Address [1] 321173 0
Country [1] 321173 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317350 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 317350 0
Ethics committee country [1] 317350 0
Australia
Date submitted for ethics approval [1] 317350 0
16/04/2025
Approval date [1] 317350 0
Ethics approval number [1] 317350 0

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

Contacts
Principal investigator
Name 140766 0
A/Prof Cindy Mak
Address 140766 0
Department of Breast Surgery, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140766 0
Australia
Phone 140766 0
+61 2 8514 0000
Fax 140766 0
Email 140766 0
[email protected]
Contact person for public queries
Name 140767 0
Chu Luan Nguyen
Address 140767 0
Department of Breast Surgery, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140767 0
Australia
Phone 140767 0
+61 2 8514 0000
Fax 140767 0
Email 140767 0
[email protected]
Contact person for scientific queries
Name 140768 0
Chu Luan Nguyen
Address 140768 0
Department of Breast Surgery, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140768 0
Australia
Phone 140768 0
+61 2 8514 0000
Fax 140768 0
Email 140768 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, individual participant data will not be shared in this study. We are committed to protecting the privacy and confidentiality of all participants. Data collected during the study will be used solely for research purposes and will be kept securely. In addition, any results published will be presented in a way that ensures no personal information is identifiable



What supporting documents are/will be available?

Current supporting documents:

Updated to:
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.