At-home Breast Oncology Care Delivered With E-health Solutions
Recruiting · NCT05989477 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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: 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
Who can take part
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
Where it is running
1 location listed.
- Tulin Cil - Toronto, Ontario, Canada