Overview
The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting the need for high quality virtual patient care. Our team has developed a multi-dimensional remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to use during the diagnostic and follow-up period. The ABODE study involved development of a Breast Cancer Treatment Application (app) which will facilitate virtual consultations, deliver patient education material, and collect patient reported outcome measures (PROMs). Using a randomized controlled trial design, the team will evaluate a variety of outcomes for breast cancer patients who will use the app throughout their diagnosis and treatment period.
Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year among newly diagnosed breast cancer patients between those using the app and those receiving standard care.
Secondary Objectives:
- Compare additional PROMs between the standard care and intervention groups
- Describe health service outcomes among app users
- Explore end-user experience of using the app
- Measure activity levels using wearable devices
Description
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.
Eligibility
Inclusion Criteria:
- Females (assigned female at birth)*
- Diagnosed with first, primary invasive BC
- Must have surgery as their first step in treatment pathway
- Ageā„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