The COVID-19 pandemic has significantly impacted healthcare service delivery,highlighting the need for high quality virtual patient care. Our team has developed amulti-dimensional remote eHealth solution for newly diagnosed breast cancer patients andtheir practitioners to use during the diagnostic and follow-up period. The ABODE studyinvolved development of a Breast Cancer Treatment Application (app) which will facilitatevirtual consultations, deliver patient education material, and collect patient reportedoutcome measures (PROMs). Using a randomized controlled trial design, the team willevaluate a variety of outcomes for breast cancer patients who will use the app throughouttheir diagnosis and treatment period.Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1year among newly diagnosed breast cancer patients between those using the app and thosereceiving standard care.Secondary Objectives: 1. Compare additional PROMs between the standard care and intervention groups 2. Describe health service outcomes among app users 3. Explore end-user experience of using the app 4. Measure activity levels using wearable devices
To measure the effect of the app compared to the standard care approach, the study team
will conduct a randomized controlled trial of 200 newly diagnosed breast cancer patients
seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100)
will receive access to the app in addition to standard care for 13 months following their
diagnosis. The control group (n=100) will have standard care. Both arms will be provided
with a Fitbit wearable device.
The PAM-13 scale assesses patient activation, defined as the knowledge and confidence a
patient has in self- management of one's health. Research team will test whether use of
the app improves PAM-13 scores at the 12-month follow-up.
Additionally, secondary outcomes will be assessed with data from additional
patient-reported outcome measures (PROMs), chart review, hospital administrative
databases, and Fitbits. All participants will complete PROMs at baseline, 6- and 12-
months post diagnosis via REDCap survey links sent through email. The intervention group
will have access to the app for 13 months following randomization.
Other: At-home Breast Oncology care Delivered with E-health solutions - ABODE
The development and implementation of the Breast Cancer Treatment Application (BCTA) will
facilitate a secure approach to virtual care for Breast Cancer patients, provide patient
specific treatment education and facilitate evaluation of Patient Reported Outcome
Measures.
Inclusion Criteria:
- Females (assigned female at birth)*
- Diagnosed with first, primary invasive BC
- Must have surgery as their first step in treatment pathway
- Age≥18
- Access to an electronic device with connection to the internet
- A valid email address
- Can communicate in English *Since BC risk is sex-related and based on physiological
values, our inclusion criteria are based on sex (not gender)
Exclusion criteria:
- Males (assigned male at birth), as BC surgical treatment options and experiences are
different
- Diagnosed with non-operable breast cancer
- Stage 4/metastatic (whether determined at diagnosis or during surgery)
- Those with hearing or visual challenges
- Neo-adjuvant chemotherapy
- Should not be enrolled in any other UHN study using an e-Health application
- Breast cancer surgery is scheduled for less 5 business days after enrollment
Tulin Cil
Toronto, Ontario, Canada
Investigator: Tulin Cil, MD, MEd
Contact: 4169464507
tulin.cil@uhn.ca
Tulin Cil, MD, MEd
416-946-4507 - 3984
tulin.cil@uhn.ca
Emma Reel, MSW
647-202-1028
emma.reel@uhn.ca
Tulin Cil, MD, MEd, Principal Investigator
University Health Network, Toronto