Clinical trial · Interventional
At-home Breast Oncology Care Delivered With E-health Solutions
At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Activation | — | UNRESOLVED | — |
| Patient Engagement | — | UNRESOLVED | — |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| At-home Breast Oncology care Delivered with E-health solutions - ABODE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- The control arm will receive standard treatment.
- type
- EXPERIMENTAL
- label
- Interventional Arm
- description
- Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.
- interventionNames
- Other: At-home Breast Oncology care Delivered with E-health solutions - ABODE
Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- At baseline, 6 months and 12 months after enrollment
- description
- To compare changes in patient activation (assessed by Patient Activation Measure -13) over 1 year among newly diagnosed breast cancer patients between those using the Breast Cancer Treatment Application (BCTA) and those receiving standard care. Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level. Patient activation is defined as the knowledge, skills, and confidence a person has in managing their health and care. Studies have shown that higher patient activation is associated with improved health related quality of life (HRQoL) and lower health care utilization.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMac A, Kalia M, Reel E, Amir E, Isenberg A, Kim RH, Kennedy E, Koch CA, Li M, McCready D, Metcalfe K, Okrainec A, Papadakos J, Rotstein S, Rodin G, Xu W, Zhong T; ABODE Study Group; Cil TD. At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial. BMJ Open. 2025 May 8;15(5):e091579. doi: 10.1136/bmjopen-2024-091579. PMID 40345693