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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-06-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Tulin Cil, MD, MEd
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05989477 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Patient Engagement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989477 currently recruiting?
Yes, NCT05989477 is actively recruiting participants. Contact the research team at tulin.cil@uhn.ca for enrollment information.
Where is the NCT05989477 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05989477 clinical trial?
NCT05989477 is sponsored by University Health Network, Toronto. The principal investigator is Tulin Cil, MD, MEd at University Health Network, Toronto. The trial plans to enroll 200 participants.