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Trial Title:
At-home Breast Oncology Care Delivered With E-health Solutions
NCT ID:
NCT05989477
Condition:
Patient Engagement
Patient Activation
Patient Reported Outcome Measures
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
e-Health
m-Health
Mobile Application
Psychosocial Oncology
Survivorship
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
After randomization patients will be told what experimental arm they are in.
Intervention:
Intervention type:
Other
Intervention name:
At-home Breast Oncology care Delivered with E-health solutions - ABODE
Description:
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.
Arm group label:
Interventional Arm
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
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tulin Cil
Address:
City:
Toronto
Zip:
M5G2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Tulin Cil, MD, MEd
Phone:
4169464507
Email:
tulin.cil@uhn.ca
Contact backup:
Last name:
Emma Reel, MSW
Phone:
6472021028
Email:
emma.reel@uhn.ca
Start date:
June 22, 2023
Completion date:
June 22, 2026
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05989477
