Clinical trial NCT05989477: At-home Breast Oncology Care Delivered With E-health Solutions
Official title: At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Engagement
Patient Activation
Patient Reported Outcome Measures
Keywords: e-Health
m-Health
Mobile Application
Psychosocial Oncology
Survivorship
Breast Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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. 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.

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

Primary outcomes:
measure: Primary Objective
timeFrame: At baseline, 6 months and 12 months after enrollment
Secondary outcomes:
measure: PROM 1: Impact of Events Scale - Revised (IES-R)
timeFrame: At baseline, 6 and 12 months after diagnosis
measure: PROM 2: Generalized Anxiety Disorder (GAD-7)
timeFrame: At baseline, 6 and 12 months after diagnosis
measure: PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: At baseline, 6-months and 12-months post-diagnosis
measure: PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: At baseline, 6-months and 12-months after enrollment
measure: PROM 5: Self-Identification Survey
timeFrame: At baseline
measure: PROM 6: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire INFO 25 (EORTC QLQ-INFO 25).
timeFrame: 9-months post-diagnosis
measure: PROM 7: The Health Information Questionnaire (heiQ)
timeFrame: At baseline, 9 months post-diagnosis
measure: PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS)
timeFrame: 6 and 12 months post-diagnosis
measure: PROM 9: Other Health App Questionnaire (OHA)
timeFrame: 6 and 12 months post-diagnosis
measure: PROM 10: The Duke Activity Status Index (DASI)
timeFrame: Baseline
measure: PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)
timeFrame: 1 Week Post Genetic Test Results via BCTA
measure: PROM 12: The Knowgene
timeFrame: 1 Week Post Genetic Test Results via BCTA
measure: PROM 13: Breast Cancer Treatment Application Review Survey (BCTA)
timeFrame: 12-months Post-Enrollment
measure: PROM 14: Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score
timeFrame: 2 to 3 Months Post Start of Endocrine Treatment via Breast Cancer Treatment App
measure: PROM 15: System-Usability Score (SUS)
timeFrame: 12-months Post-Enrollment
measure: PROM 16: Distress Thermometer
timeFrame: At baseline, 6 months and 12 months after enrollment
measure: PROM 17: Post Operative Questionnaires
timeFrame: 1 to 10 days after surgery
measure: Visits to the Breast Clinic
timeFrame: 3, 9 and 15 months after enrollment
measure: Phone Calls and Emails to the Breast Clinic
timeFrame: 3, 6, and 15 months after enrollment
measure: Emergency Department Visits
timeFrame: 15 months post enrollment
measure: Unplanned Hospital Admissions
timeFrame: 15 months post enrollment
measure: Outpatient Clinic Visits
timeFrame: 15 months post enrollment
measure: Physical Activity Level (Steps per Day)
timeFrame: 13 months after enrollment (whole duration of the study)
measure: Exercise Heart Rate
timeFrame: 13 months after enrollment (whole duration of the study)
measure: Sleep Duration
timeFrame: 13 months after enrollment (whole duration of the study)
measure: Hospital Admissions
timeFrame: 15 months post enrollment
measure: Length of Hospital Stay
timeFrame: 15 months post enrollment
measure: Discharge Outcomes
timeFrame: 15 months post enrollment
measure: Post-Surgical Complications
timeFrame: 15 months post enrollment
measure: Wait Times
timeFrame: 15 months post enrolment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Tulin Cil
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Tulin Cil, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References: