At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial

Abstract

Introduction: The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one's health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. The app facilitates virtual assistance, delivers educational resources, collects patient-reported outcome measures and provides individualised support via volunteer e-coaches. Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health service outcomes over 1 year between those using the app and Fitbit, and those receiving standard care and Fitbit only.

Methods and analysis: This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will use the app in addition to standard care and Fitbit for 13 months following diagnosis. The control group (n=100) will receive standard care and Fitbit only. Patients will complete questionnaires at enrolment, 6 and 12 months post-diagnosis to measure patient activation (Patient Activation Measure-13 score), distress, anxiety, quality of life and experiences with their care and information received. All patients will also receive Fitbits to measure activity and heart rate. We will also measure wait times and number of visits to ambulatory care services to understand the impact of the app on the use of in-person services.

Ethics and dissemination: Ethics approval was obtained on 6 January 2023. Protocol version 2.0 was approved on 6 January 2023. The trial is registered with ClinicalTrials.gov. Study findings will be disseminated via publication in a peer-reviewed journal and shared with participants, patient programmes and cancer awareness groups. The app has also been approved as a secure communication method at our trial institution, thus we are well-positioned to support future integration of the app into standard care through collaboration with our hospital network.

Trial registration number: NCT05989477.

Keywords: Breast surgery; Breast tumours; Randomized Controlled Trial; eHealth.

Figure 1. Timeline of study. Fitbit variables and app user activities are collected continuously throughout the study duration, and health service outcomes are collected at the end of the study. CEQ, Clinical Evaluation Questionnaire; DASI, Duke Activity Status Index; DT, Distress Thermometer; EORTC, European Organisation for Research and Treatment of Cancer; FACT-ES, Functional Assessment of Cancer Therapy-Endocrine Symptoms; GAD, General Anxiety Disorder Screener; heiQ, Health Information Questionnaire; IES, Impact of Events Scale; INFO-25, Information Module; MICRA, Multidimensional Impact of Cancer Risk Assessment; OHA, Other Health App Questionnaire; PAM, Patient Activation Measure; QLQ-BR23, Quality of Life Questionnaires—Breast- 23; QLQ-C30, Quality of Life Questionnaires—Core-30; SUS, System Usability Scale.