At-home Breast Oncology Care Delivered With E-health Solutions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females (assigned female at birth)*
Diagnosed with first, primary invasive BC
Must have surgery as their first step in treatment pathway
Age≥18
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
At-home Breast Oncology care Delivered with E-health solutions - ABODE
Other interventionThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Interventional ArmExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
At baseline, 6 months and 12 months after enrollmentSecondary outcomes
1
PROM 1: Impact of Events Scale - Revised (IES-R)
Number of participants with PTSD symptoms, such as distress in regards to their Breast Cancer diagnosis and treatment as assessed by IES-R. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms.
Time frame
At baseline, 6 and 12 months after diagnosis2
PROM 2: Generalized Anxiety Disorder (GAD-7)
Number of participant with generalized anxiety around their breast cancer diagnosis and treatment assessed by GAD-7. The GAD-7 is a 7-item scale used to measure or assess the severity of generalized anxiety disorder based on symptoms.
Time frame
At baseline, 6 and 12 months after diagnosis3
PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Number of participants with changes in their physical, psychological and social functions during and after their diagnosis and surgery, assessed by the EORTC QLQ-C30. The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time frame
At baseline, 6-months and 12-months post-diagnosis4
PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Number of participants with changes in their quality of life after their breast cancer diagnosis and treatment journey assessed by the EORTC QLQ-BR23. The survey includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Time frame
At baseline, 6-months and 12-months after enrollmentSponsors and contacts
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Source ClinicalTrials.gov