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Recruiting NCT05989477

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

No phase Interventional Patient Engagement Patient Activation Patient Reported Outcome Measures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: At-home Breast Oncology care Delivered with E-health solutions - ABODE.
Who it may be relevant to
Registry conditions: Patient Engagement, Patient Activation, Patient Reported Outcome Measures. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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 measures

  • Primary Objective [Time frame: At baseline, 6 months and 12 months after enrollment]
Secondary outcome measures (12)
  • PROM 1: Impact of Events Scale - Revised (IES-R) [Time frame: At baseline, 6 and 12 months after diagnosis]
  • PROM 2: Generalized Anxiety Disorder (GAD-7) [Time frame: 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) [Time frame: 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) [Time frame: At baseline, 6-months and 12-months after enrollment]
  • PROM 5: Self-Identification Survey [Time frame: At baseline]
  • PROM 6: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire INFO 25 (EORTC QLQ-INFO 25). [Time frame: 9-months post-diagnosis]
  • PROM 7: The Health Information Questionnaire (heiQ) [Time frame: At baseline, 9 months post-diagnosis]
  • PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS) [Time frame: 6 and 12 months post-diagnosis]
  • PROM 9: Other Health App Questionnaire (OHA) [Time frame: 6 and 12 months post-diagnosis]
  • PROM 10: The Duke Activity Status Index (DASI) [Time frame: Baseline]
  • PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA) [Time frame: 1 Week Post Genetic Test Results via BCTA]
  • PROM 12: The Knowgene [Time frame: 1 Week Post Genetic Test Results via BCTA]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • Tulin Cil — Toronto

Publications

  • 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

Identifiers

NCT: NCT05989477 · 20-6232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗