Recruiting

Breast Cancer App

Sponsor:

University Health Network, Toronto

Code:

NCT05989477

Conditions

Patient Engagement

Patient Activation

Patient Reported Outcome Measures

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

At-home Breast Oncology care Delivered with E-health solutions - ABODE

Study Details

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

Conditions

Patient Engagement

Patient Activation

Patient Reported Outcome Measures

Study ID

NCT05989477

Start date

Jun 22, 2023

Status verified date

Apr, 2025

Completion date

Jun 22, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females (assigned female at birth)\*
  • Diagnosed with first, primary invasive BC
  • Must have surgery as their first step in treatment pathway
  • Ageā‰„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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Arm

The control arm will receive standard treatment.

experimental: Interventional Arm

Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.

Interventions

At-home Breast Oncology care Delivered with E-health solutions - ABODE

The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.

Primary outcome measure

  • Primary Objective [ Time Frame: At baseline, 6 months and 12 months after enrollment ]

Central Contacts and Locations

Central contacts

Tulin Cil, MD, MEd

416-946-4507tulin.cil@uhn.ca

Emma Reel, MSW

647-202-1028emma.reel@uhn.ca

Locations

Tulin Cil

Recruiting

Toronto, Ontario, Canada, M5G2M9

Contacts

Tulin Cil, MD, MEd

4169464507tulin.cil@uhn.ca

Emma Reel, MSW

6472021028emma.reel@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Keywords

  • e-Health
  • m-Health
  • Mobile Application
  • Psychosocial Oncology
  • Survivorship
  • Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-04-16.