Breast ReconstructionNCT07696637
Access My Breast Cancer Care App
A study testing Access My Breast Cancer Care App and Standard Pathway in people with Breast Reconstruction and Breast Cancer, run by University of British Columbia at 2 sites in Canada.
Trial summary
The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- What is being tested?
- Access My Breast Cancer Care App and Standard Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Apr 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are at least 19 years of age (the team only treats adult patients)
- You have a diagnosis of breast cancer, or a BRCA mutation, and will be -having breast surgery with reconstruction (the app is tailored the breast cancer journey)
- You have access to a smartphone or computer (individuals participating in the study will require access to a smart phone or computer to access the application if randomized to the intervention group)
- Must have basic reading skills in English (the app is only available in English language)
Who cannot join
- You do not have access to a smartphone or computer (a computer or smart phone is required to access the application)
- You are <19 years of age (the team does not treat pediatric patients)
- You do not have breast cancer or a BRCA mutation (the application is specific to the breast cancer journey)
- You decline breast reconstruction (the application was designed by the plastics and reconstructive team, and with the app being in an infancy stage, the bulk of the content focuses on breast reconstruction surgery)
- You are not able to read English (the app is only available in English language)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Providence Health Care
Vancouver, British Columbia
Selena Banser Clinical Nurse Specialist, 236-997-9112, selena.banser@vch.ca
- Recruiting
Vancouver Coastal Health
Vancouver, British Columbia
Selena Banser Clinical Nurse Specialist, 236-997-9112, selena.banser@vch.ca
About this study
Official title: Access my Breast Cancer Care - Use of an eHealth App in Navigating the Breast Cancer Trajectory: A Randomized Controlled Trial
The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Isaac, Selena (CNS) and Pauline (CNS)) provided clinical expertise to ensure accuracy of clinical content. The application houses educational resources, a calendar, symptom tracker, customizable care pathway, community forum and a chat feature. The study will be designed as a randomized controlled trial (RCT) to measure the effect of the application on patient-centered outcomes of 1) satisfaction with care 2) reduction in adverse events, 3) usability. The investigators will conduct focus groups to understand the benefit of the app from the patient perspective.
Read the detailed description
Background: This App has been developed by stakeholders engaged in breast cancer reconstruction, including patients, physicians, allied health workers, hospital administration, and hospital leadership. Its development and evaluation follow the Cancer Care Research framework to ensure its utility and integration are optimized for impact in cancer care
Purpose: To evaluate whether a centralized breast cancer care app can improve patient navigation, empowerment, and decision-making, while also reducing the number of in person clinic visits, and time from symptom onset to specialist review. The investigators will also evaluate app usability and usage.
Hypothesis: Providing patients with access to the "Access my Breast Cancer Care" app will improve patient care satisfaction and patient outcomes compared to usual standard care, resulting in fewer in person clinic visits, high satisfaction of care, earlier detection of complications, and greater patient confidence in managing their care.
Justification: Breast cancer patients often face fragmented care and difficulty accessing timely resources. A centralized app may provide consistent support, improve communication, and enhance efficiency in care delivery. Evaluating its impact is necessary to determine the benefits to patients and potential cost savings for the healthcare system.
Objectives: 1) To evaluate, from the patient perspective, the impact of a centralized breast cancer app on navigation of the breast cancer journey when undergoing reconstruction; 2) To evaluate the impact of a centralized breast cancer app on the delivery of care, including number of in-person specialist visits and time from symptom onset to specialist review; 3) To evaluate the app usability and usage during the breast cancer journey.
Research design: A mixed methods approach will be utilized. A randomized control trial with both quantitative and qualitative data will be collected and analyzed. Quantitative outcomes include BREAST-Q scores, MARS scores, SUS scores, and delivery of care quality indicators.
Statistical analysis: Qualitative analysis will be completed using constant comparison and retrieval of themes. Primary analysis of patient care satisfaction using the BREAST-Q will be conducted using ANCOVA. For secondary outcomes, the investigators will apply negative binomial regression for number of in person visits, survival analysis using Kaplan-Meier curves, and log-rank test for time to specialist review, gamma regression with log link to assess information seeking time, and wilcoxon sum for app usability using the MARS and/or SUS scale. The investigators will use measures of central tendency to evaluate app usage (# of logins and # of education resources accessed).
- Conditions
- Breast Reconstruction, Breast Cancer
- Being tested
- Access My Breast Cancer Care App, Standard Pathway
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access My Breast Cancer Care AppOther
App designed by our VCH team for patients with breast cancer to navigate their care pathways
Standard PathwayOther
These patients will undergo standard breast cancer care without access to the app
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm will undergo standard breast cancer care without access to the app Receives: Other: Standard Pathway |
| App | Experimental | This arm will undergo standard breast cancer care with access to the app Receives: Other: Access My Breast Cancer Care App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does access to a centralized breast cancer app improve patient navigation during breast cancer reconstruction journey
Assessment will be made using BREAST-Q scores. The BREAST-Q is a patient-reported outcome measure where higher scores (0-100) indicate better quality of life or satisfaction.
Measured: 1 month and 6 months
Secondary outcomes (2)
Does the app improve reduce the amount of emergency room visits?
Compare the number of in emergency department visits between groups.
Measured: 1 month and 6 months
Does the app reduce wait times to specialist review?
Compare time from symptom onset to specialist review between groups
Measured: 1 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start20 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Isaac, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696637
- Sponsor's protocol ID
- H25-03017
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all de-identified IPD will be used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access my Breast Cancer Care - Use of an eHealth App in Navigating the Breast Cancer Trajectory: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07696637
- Acronym / sponsor ID
- H25-03017
- Conditions
- Breast Reconstruction, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Isaac, Selena (CNS) and Pauline (CNS)) provided clinical expertise to ensure accuracy of clinical content. The application houses educational resources, a calendar, symptom tracker, customizable care pathway, community forum and a chat feature. The study will be designed as a randomized controlled trial (RCT) to measure the effect of the application on patient-centered outcomes of 1) satisfaction with care 2) reduction in adverse events, 3) usability. The investigators will conduct focus groups to understand the benefit of the app from the patient perspective.
Detailed description
Background: This App has been developed by stakeholders engaged in breast cancer reconstruction, including patients, physicians, allied health workers, hospital administration, and hospital leadership. Its development and evaluation follow the Cancer Care Research framework to ensure its utility and integration are optimized for impact in cancer care
Purpose: To evaluate whether a centralized breast cancer care app can improve patient navigation, empowerment, and decision-making, while also reducing the number of in person clinic visits, and time from symptom onset to specialist review. The investigators will also evaluate app usability and usage.
Hypothesis: Providing patients with access to the "Access my Breast Cancer Care" app will improve patient care satisfaction and patient outcomes compared to usual standard care, resulting in fewer in person clinic visits, high satisfaction of care, earlier detection of complications, and greater patient confidence in managing their care.
Justification: Breast cancer patients often face fragmented care and difficulty accessing timely resources. A centralized app may provide consistent support, improve communication, and enhance efficiency in care delivery. Evaluating its impact is necessary to determine the benefits to patients and potential cost savings for the healthcare system.
Objectives: 1) To evaluate, from the patient perspective, the impact of a centralized breast cancer app on navigation of the breast cancer journey when undergoing reconstruction; 2) To evaluate the impact of a centralized breast cancer app on the delivery of care, including number of in-person specialist visits and time from symptom onset to specialist review; 3) To evaluate the app usability and usage during the breast cancer journey.
Research design: A mixed methods approach will be utilized. A randomized control trial with both quantitative and qualitative data will be collected and analyzed. Quantitative outcomes include BREAST-Q scores, MARS scores, SUS scores, and delivery of care quality indicators.
Statistical analysis: Qualitative analysis will be completed using constant comparison and retrieval of themes. Primary analysis of patient care satisfaction using the BREAST-Q will be conducted using ANCOVA. For secondary outcomes, the investigators will apply negative binomial regression for number of in person visits, survival analysis using Kaplan-Meier curves, and log-rank test for time to specialist review, gamma regression with log link to assess information seeking time, and wilcoxon sum for app usability using the MARS and/or SUS scale. The investigators will use measures of central tendency to evaluate app usage (# of logins and # of education resources accessed).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard PathwayThis arm will undergo standard breast cancer care without access to the app |
| App | Experimental | Other: Access My Breast Cancer Care AppThis arm will undergo standard breast cancer care with access to the app |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- You are at least 19 years of age (the team only treats adult patients)
- You have a diagnosis of breast cancer, or a BRCA mutation, and will be -having breast surgery with reconstruction (the app is tailored the breast cancer journey)
- You have access to a smartphone or computer (individuals participating in the study will require access to a smart phone or computer to access the application if randomized to the intervention group)
- Must have basic reading skills in English (the app is only available in English language)
Key exclusion criteria (5 listed)
- You do not have access to a smartphone or computer (a computer or smart phone is required to access the application)
- You are <19 years of age (the team does not treat pediatric patients)
- You do not have breast cancer or a BRCA mutation (the application is specific to the breast cancer journey)
- You decline breast reconstruction (the application was designed by the plastics and reconstructive team, and with the app being in an infancy stage, the bulk of the content focuses on breast reconstruction surgery)
- You are not able to read English (the app is only available in English language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access My Breast Cancer Care AppApp designed by our VCH team for patients with breast cancer to navigate their care pathways | Other | App |
| Standard PathwayThese patients will undergo standard breast cancer care without access to the app | Other | Control |
Primary outcome
Does access to a centralized breast cancer app improve patient navigation during breast cancer reconstruction journey
Time frame: 1 month and 6 months
Assessment will be made using BREAST-Q scores. The BREAST-Q is a patient-reported outcome measure where higher scores (0-100) indicate better quality of life or satisfaction.
2 secondary outcomes
Does the app improve reduce the amount of emergency room visits?
Time frame: 1 month and 6 months
Does the app reduce wait times to specialist review?
Time frame: 1 month and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. all de-identified IPD will be used in the results publication
Related trials for Breast Reconstruction
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Recruiting
Comparison of Mastectomy Expander Trial
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
RecruitingPhase 1
ESP Blocks in Breast Free Flaps
Breast Reconstruction, Free Flap Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access My Breast Cancer Care App and Standard Pathway in people with Breast Reconstruction and Breast Cancer, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selena Banser Clinical Nurse Specialist, RN (236-997-9112, selena.banser@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does access to a centralized breast cancer app improve patient navigation during breast cancer reconstruction journey (time frame: 1 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.