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

NCT05989477 | Recruiting DMC

• 1 other identifier: 20-6232
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Patient Engagement; Patient Activation; Patient Reported Outcome Measures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  To compare changes in patient activation (assessed by Patient Activation Measure -13) over 1 year among newly diagnosed breast cancer patients between those using the Breast Cancer Treatment Application (BCTA) and those receiving standard care. Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level. Patient activation is defined as the knowledge, skills, and confidence a person has in managing their health and care. Studies have shown that higher patient activation is associated with improved health related quality of life (HRQoL) and lower health care utilization.

  At baseline, 6 months and 12 months after enrollment

Secondary Outcomes (30)

• PROM 1: Impact of Events Scale - Revised (IES-R)

  At baseline, 6 and 12 months after diagnosis

• PROM 2: Generalized Anxiety Disorder (GAD-7)

  At baseline, 6 and 12 months after diagnosis

• PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

  At baseline, 6-months and 12-months post-diagnosis

• PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)

  At baseline, 6-months and 12-months after enrollment

• PROM 5: Self-Identification Survey

  At baseline

Study Arms (2)

Control Arm

NO INTERVENTION

The control arm will receive standard treatment.

Interventional Arm

EXPERIMENTAL

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

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

Interventions

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

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Tulin Cil

Toronto, Ontario, M5G2M9, Canada

RECRUITING

Related Publications (1)

• Mac A, Kalia M, Reel E, Amir E, Isenberg A, Kim RH, Kennedy E, Koch CA, Li M, McCready D, Metcalfe K, Okrainec A, Papadakos J, Rotstein S, Rodin G, Xu W, Zhong T; ABODE Study Group; Cil TD. At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial. BMJ Open. 2025 May 8;15(5):e091579. doi: 10.1136/bmjopen-2024-091579.

  PMID: 40345693 DERIVED

MeSH Terms

Conditions

Patient Participation; Breast Neoplasms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tulin Cil, MD, MEd

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tulin Cil, MD, MEd

CONTACT

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

Emma Reel, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After randomization patients will be told what experimental arm they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 14, 2023
• Study Start: June 22, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 22, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)