At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial.
Amanda Mac, Mohini Kalia, Emma Reel...
https://pubmed.ncbi.nlm.nih.gov/40345693Actively Recruiting
Led by University Health Network, Toronto · Updated on 2025-04-16
200
Participants Needed
1
Research Sites
24 weeks
Total Duration
Researchers are evaluating a new eHealth solution designed for women newly diagnosed with breast cancer to improve virtual care during diagnosis and treatment. The study compares the use of a Breast Cancer Treatment Application (BCTA) with standard care in a randomized controlled trial, aiming to assess patient activation and various patient-reported outcomes over a year. This app helps patients with virtual consultations, provides educational materials, and collects important health information remotely. The trial involves 200 female patients divided into two groups: one receiving standard care and the other receiving standard care plus access to the BCTA for 13 months. Both groups will receive Fitbit devices to monitor physical activity and health data. The study collects data at multiple points including baseline, 6 months, and 12 months post-diagnosis, using surveys and clinical records to measure outcomes such as anxiety, quality of life, and treatment experiences. Participants will complete several questionnaires online and wear Fitbits to track activity levels, sleep, and heart rate throughout the study. Researchers will also review healthcare usage like clinic visits and hospital admissions. The primary measure is the change in patient activation after one year, with secondary measures including other patient-reported outcomes and health service use. The total participation time is approximately 13 to 15 months from enrollment.
CONDITIONS
At-home Breast Oncology Care Delivered With E-health Solutions
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 13 months
Participants in the intervention group receive access to the Breast Cancer Treatment Application (BCTA) in addition to standard care for 13 months. The control group receives standard care only. Both groups use a Fitbit device to track physical activity, heart rate, and sleep.
PROMs completed at baseline, 6 months, 9 months, and 12 months post diagnosis; visits to the Breast Clinic at 3, 9, and 15 months; phone calls and emails to the Breast Clinic at 3, 6, and 15 months
Duration - Up to 15 months post enrollment
Participants are monitored for healthcare utilization and post-surgical outcomes up to 15 months post enrollment, including emergency department visits, hospital admissions, outpatient visits, and post-surgical complications.
Visits and monitoring at 15 months post enrollment
Total: 1 location
1
Tulin Cil
Toronto, Ontario, Canada, M5G2M9
Actively Recruiting
T
Tulin Cil, MD, MEd
E
Emma Reel, MSW
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Amanda Mac, Mohini Kalia, Emma Reel...
https://pubmed.ncbi.nlm.nih.gov/40345693