Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID05989477

At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study

Led by University Health Network, Toronto · Updated on 2025-04-16

200

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

At-home Breast Oncology Care Delivered With E-health Solutions

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female (assigned female at birth)
  • Diagnosed with first, primary invasive breast cancer
  • Surgery planned as first treatment step
  • Age 18 years or older
  • Access to an electronic device with internet connection
  • Valid email address
  • Able to communicate in English
Not Eligible

You will not qualify if you...

  • Male (assigned male at birth)
  • Diagnosed with non-operable breast cancer
  • Stage 4 or metastatic breast cancer
  • Hearing or visual impairments
  • Receiving neoadjuvant chemotherapy
  • Enrolled in another eHealth application study at UHN
  • Breast cancer surgery scheduled less than 5 business days after enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Tulin Cil

Toronto, Ontario, Canada, M5G2M9

Actively Recruiting

Loading map...

Research Team

T

Tulin Cil, MD, MEd

E

Emma Reel, MSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

Effects of Exercise Therapy and Soft Brace on Knee Osteoarth...

Rehabilitation

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial