This trial is a randomised, controlled, single-centre, superiority trial with two parallel groups and a primary objective of comparing changes in patient activation as measured by the PAM-13 scale over 1 year. A total of 200 newly diagnosed patients with breast cancer from the largest Canadian cancer centre will be randomised; the intervention group will have access to the app in addition to standard care and Fitbit (n=100), and the control group will receive standard care and Fitbit only (n=100). We selected a timeframe of 1 year, as change in patient activation over time is typically measured by comparing baseline PAM-13 scores to scores taken 6–12 months later.27

Participants will receive care at our hospital, an urban research centre specialised in cancer treatment. Our hospital network has previously employed similar eHealth applications in other disease sites for sharing educational materials with patients and collecting PROMs.

Patients must provide written, informed consent to participate in the study (online supplemental appendix 1).

Inclusion criteria:

Exclusion criteria:

We consider sex as a biological variable and gender as a sociocultural factor. This study will only include patients assigned female at birth, as breast cancer predominantly affects females.28 Since breast cancer risk is sex-related and based on physiological values, our inclusion criteria are based on sex.28 Patients receiving NAC were excluded, as patients must have surgery as their first step in their treatment pathway to be included in the study. Patients must have surgery as their first step in their treatment pathway, as the app was designed to administer PROMs pertaining to postoperative care. The app also does not provide educational materials or support specific to patients undergoing NAC prior to surgery.

The app is approved by our hospital network as a secure communication method. The app requires users to create a username and password to log into their personal account. The app enforces strong passwords, supports two-factor authentication and detection of compromised passwords to improve user account security. All data on the app are encrypted in transit and at rest. The app is hosted in highly secure Tier IV data centres managed by a cloud provider which maintains an industry-leading array of security and privacy certifications, including Systems and Organization Controls (SOC) 2 Type 2 as well as the International Organization of Standardization 27000 family of certifications. NexJ Health, which is the platform that the app is hosted on, maintains SOC 2 Type 2 certification. We use the Template for Intervention Description and Replication to report the development of the app.29

Patients in both arms of the study were provided with a Fitbit wearable health tracker, which can be worn around the wrist. The dashboard of the Breast Cancer Treatment Application includes a tracker section, which displays information that is collected from their Fitbit device, allowing patients to view their health tracker data within the app. The Fitbit continuously collects information regarding activity level, sleep and fluctuations in heart rate. The provision of Fitbits is not part of standard care at our institution.

Patients in the control group will receive standard care only and use the Fitbit. At our centre, standard care includes in-person outpatient consultation and appropriate follow-up, either in-person or virtual, with disciplines involved in breast cancer treatment, as indicated (breast surgery, plastic surgery, medical oncology, radiation oncology). Patients in the control group also have access to the Care and Connect Programme at our centre. However, patients in the control group will not have the option to connect or communicate with their e-coach via the app and can only do so via other means (email, phone call, in-person). Patients in the control group will receive reminders to complete questionnaires via email.

Participants can discontinue their involvement in the study at any time if requested. If a participant in the intervention group wishes to discontinue their involvement in the study, their app account will be deactivated. Information collected prior to a participant’s discontinuation will be used in data analysis, and no new information will be collected without their permission.

The intervention group will have access to the app for 13 months. Access will commence within 1 week of randomisation, which occurs after study entry at diagnosis. All participants will be sent survey REDCap links via email, and participants in the intervention group will additionally receive automatic reminders through the app to complete these questionnaires, which include the REDCap link to the survey (figure 1). Completion of all surveys is estimated to take 30 min at each time point.

The primary outcome is the between-group difference in the change from baseline to 12 months of the PAM-13 score. The sample size calculation was based on a clinically relevant difference of 4 points of PAM-13 change and an SD of 10.0.56 We opted to use the change in PAM-13 from baseline to 12 months, rather than the raw scores in the PAM-13, to account for the within-sample variation and provide a better understanding of the study endpoint. Based on the power calculation, 156 patients are needed to have 80% power to identify a significant difference between the two arms, with a two-sided significance level α=0.05. We have assumed a 10% participant attrition rate based on previous eHealth application studies57 in our sample size and power calculations. We have also assumed an additional 10% of potential patient drop-off. Therefore, if we account for a total attrition rate of 20%, the total required sample size is 196 (98 patients in each arm). We have rounded up our sample size to 200 (100 patients in each arm).

The planned recruitment rate for this trial is based on patient acceptance and adherence from other sites using a similar application clinically58 59 and the number of potentially eligible subjects at our cancer centre. We estimate there will be 96 eligible patients per month, based on breast centre volumes. These numbers have remained stable throughout the COVID-19 pandemic. Thus, we expect to recruit our sample size of 200 participants by our proposed recruitment completion date of 22 April 2025. Recruitment began on 22 June 2023. The number of participants accrued thus far is 76.

Participants will be randomly assigned to either the control or intervention group with a 1:1 allocation as per a computer-generated randomisation schedule using simple randomisation. Participants will be randomised using REDCap, which is an online central randomisation service. The study team is blinded to this allocation process.

Given that patients and their practitioners will know whether they have access to the app, it is not possible to blind participants to their allocation to the intervention or control group. It is also not possible to blind the CRA or CRC to the allocation of participants, as the CRA or CRC will need to communicate with patients in the intervention group via the app. However, data analysts will not be involved in patient care and will be unaware of the allocation sequence and group assignment throughout the study.

Online supplemental file 1 displays the reliability of each assessment tool used to collect our outcome measures. Each participant will be given a Fitbit activity tracker to wear during the study period. All participants will be asked to download the Fitbit application on their device. For the intervention group, the app will automatically pull the variables from the Fitbit app and display them on the patient dashboard for easy viewing. The control group will be able to view their data in the Fitbit app throughout the study.

For health service outcomes, we will collaborate with the Decision Support Team at our hospital to request data for the patients included in our study from the following sources:

• TIS: this is a web-based system that enables Ontario hospitals to capture wait time information related to surgery, diagnostic imaging and alternate level of care.

• NACRS: this database includes ambulatory clinical activity.

• DAD: this database is used to capture acute clinical activity and data will be requested from the Decision Support Team.

The survey responses from the control and intervention groups will be collected and securely stored using REDCap. Participant profile data on the app is securely stored on a Canadian-hosted IBM data cloud and only those who are part of the patient’s care team and members of the study team will have access to this data. Chart review data will be entered into a REDCap database where each patient will be identified with a unique participant ID. A separate REDCap consent database will be kept as a linking log that matches the participant ID to the patient. The study files will be stored securely in REDCap and SharePoint software, which are both approved by our hospital network. All records and documents pertaining to the study will be retained by the study trial site for 15 years from the completion of the study.

Table 1 outlines the analyses that will be conducted for outcome measures collected from all patients; the intervention group will be compared with the control group for all analyses. Table 2 outlines the analyses that will be conducted for outcome measures collected from the intervention group only. SAS and SPSS will be used to conduct analyses. For all tests, we will use two-sided p values with an alpha ≤0.05 level of significance. The statistician (YZ) at our centre is blinded to study groups, and will conduct all analyses.

Descriptive statistics will be used to summarise MICRA, postoperative survey, FACT-ES, SUS, DASI and Breast Cancer Treatment Application Review Survey scores, all baseline measures, and Self-Identification Survey and chart review results. Linear regression will be performed for Fitbit variables and all health service outcomes. Demographic and clinical characteristics from the Self-Identification Survey and chart review will be compared using Kruskal-Wallis tests for continuous variables and Fisher’s exact tests for categorical variables.

Patient partners were involved in the design, reporting and dissemination plan of this research, including the development and publication of this protocol.

Eligibility will be assessed by the CRA using the Study Screening Form (online supplemental appendix 6). There will also be a poster (online supplemental appendix 7) on the wall in the clinic that directs patients to contact the study team directly. Eligible participants will be asked if they are interested in meeting with the CRA to learn the details of the study. This conversation will occur after the patient’s appointment, during which they consented to receive surgical treatment for their breast cancer. Interested participants will be introduced to the CRA for a brief overview of the study or directed to scan a QR code to give consent to contact (online supplemental appendix 8). The CRA will give them a copy of the consent form (online supplemental appendix 1) to review and will facilitate a meeting either virtually or in person to answer any questions about the study as soon as the participant is available during a mutually agreeable time to meet. This could happen during the clinic visit if time permits. On receiving verbal confirmation of the patient’s willingness to participate in the study, the CRA will register the patient in the REDCap study database using their email address. A link to the online consent document will be automatically emailed to the patient.

Results will be shared through peer-reviewed publications and presentations at conferences. The app was designed to integrate with our hospital network’s health information system and has been customised with representation from all departments in the breast clinic. We will continue to work with the digital platforms team at our hospital network who will lead the implementation of the app. Our clinical trial team, including the CRA and CRC, will continue to be involved with implementing our app into standard care practices at our institution. Future plans to integrate the app at other cancer care centres will involve training healthcare staff at these centres to undertake the roles of the CRA and CRC (ie, responding to messages from patients within the app).

Not applicable.