- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07696637
Access My Breast Cancer Care App
Access my Breast Cancer Care - Use of an eHealth App in Navigating the Breast Cancer Trajectory: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Selena Banser Clinical Nurse Specialist, RN
- Phone Number: 236-997-9112
- Email: selena.banser@vch.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Recruiting
- Providence Health Care
-
Contact:
- Selena Banser Clinical Nurse Specialist
- Phone Number: 236-997-9112
- Email: selena.banser@vch.ca
-
Vancouver, British Columbia, Canada
- Recruiting
- Vancouver Coastal Health
-
Contact:
- Selena Banser Clinical Nurse Specialist
- Phone Number: 236-997-9112
- Email: selena.banser@vch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
This arm will undergo standard breast cancer care without access to the app
|
These patients will undergo standard breast cancer care without access to the app
|
|
Experimental: App
This arm will undergo standard breast cancer care with access to the app
|
App designed by our VCH team for patients with breast cancer to navigate their care pathways
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does the app improve reduce the amount of emergency room visits?
Time Frame: 1 month and 6 months
|
Compare the number of in emergency department visits between groups.
|
1 month and 6 months
|
|
Does the app reduce wait times to specialist review?
Time Frame: 1 month and 6 month
|
Compare time from symptom onset to specialist review between groups
|
1 month and 6 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-03017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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