At-home Breast Oncology Care Delivered With E-health Solutions (ABODE)

University Health Network, Toronto

Status

Enrolling

Conditions

Patient Activation

Patient Reported Outcome Measures

Patient Engagement

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05989477

20-6232

Details and patient eligibility

About

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:

Compare additional PROMs between the standard care and intervention groups
Describe health service outcomes among app users
Explore end-user experience of using the app
Measure activity levels using wearable devices

Full description

To measure the effect of the app compared to the standard care approach, the study team will conduct a randomized controlled trial of 200 newly diagnosed breast cancer patients seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will receive access to the app in addition to standard care for 13 months following their diagnosis. The control group (n=100) will have standard care. Both arms will be provided with a Fitbit wearable device.

The PAM-13 scale assesses patient activation, defined as the knowledge and confidence a patient has in self- management of one's health. Research team will test whether use of the app improves PAM-13 scores at the 12-month follow-up.

Additionally, secondary outcomes will be assessed with data from additional patient-reported outcome measures (PROMs), chart review, hospital administrative databases, and Fitbits. All participants will complete PROMs at baseline, 6- and 12- months post diagnosis via REDCap survey links sent through email. The intervention group will have access to the app for 13 months following randomization.

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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