NCT05989477 At-home Breast Oncology Care Delivered With E-health Solutions
| NCT ID | NCT05989477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Patient Engagement |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-22 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief Summary
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
Eligibility Criteria
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