What side effects are associated with this type of intervention?

The most common treatments for patient engagement, such as those facilitated by the Breast Cancer Treatment Application, include virtual consultations, patient education, and the collection of patient-reported outcome measures (PROMs). Known side effects of these treatments are generally minimal but can include mild headaches, feelings of cold, and occasional discomfort from prolonged use of digital devices. Additionally, some patients may experience anxiety or stress related to the use of new technology or the reporting of symptoms. Overall, these side effects are typically mild and manageable.

What prior FDA approvals exist?

The FDA has approved several digital health solutions aimed at enhancing patient engagement, particularly in the context of chronic disease management and oncology. One notable example is the approval of digital therapeutics for conditions like ADHD, which include game-based applications designed to improve attention function in children. While specific FDA approvals for applications exactly like the Breast Cancer Treatment Application are not detailed, the trend towards using eHealth solutions for virtual consultations, patient education, and the collection of patient-reported outcomes is evident. These digital tools are increasingly recognized for their potential to improve patient activation and engagement in their own care.

What other types of research exist?

Promising alternatives to the Breast Cancer Treatment Application for patient engagement in 2024 include: 1) Telehealth platforms with integrated oncology-specific features, such as OncoHealth, which offer virtual consultations and personalized care plans. 2) Mobile health apps like MyCancerCoach, which provide tailored educational content and track patient-reported outcomes. 3) Wearable devices combined with AI-driven analytics, such as Apple HealthKit integrated with oncology apps, to monitor patient health metrics and provide real-time feedback. 4) Comprehensive patient portals like Epic MyChart, which facilitate communication with healthcare providers, access to medical records, and management of treatment schedules.

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Behavioural Intervention

E-Health Solutions for Breast Cancer (ABODE Trial)

N/A

Recruiting

Led By Tulin Cil, MD, MEd

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months post-diagnosis

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app for newly diagnosed breast cancer patients to help manage their care remotely. The app allows virtual consultations, provides educational materials, and collects patient feedback. The goal is to see if the app improves patient engagement and health outcomes.

Who is the study for?

This trial is for women diagnosed with early-stage breast cancer who need surgery first. They must be over 18, speak English, have internet access and an email. It's not for those with advanced cancer, scheduled immediate surgery, enrolled in similar studies or with sensory challenges.

What is being tested?

The ABODE study tests a Breast Cancer Treatment App against standard care. The app offers virtual consultations, educational materials, and tracks patient outcomes. The main goal is to see if the app improves patient engagement over a year.

What are the potential side effects?

Since this trial involves an e-health solution rather than medication, traditional side effects are not applicable. However, users may experience issues related to technology use such as eye strain or stress from technical difficulties.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months post-diagnosis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months post-diagnosis

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months post-diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objective

Secondary study objectives

PROM 10: The Duke Activity Status Index (DASI)

PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)

PROM 12: The Knowgene

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional ArmExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 Intervention

The control arm will receive standard treatment.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Breast Cancer Treatment Application enhances patient engagement through three primary mechanisms: virtual consultations, patient education, and collection of patient-reported outcome measures (PROMs). Virtual consultations provide continuous and convenient access to healthcare professionals, fostering timely medical advice and emotional support. Patient education materials empower patients with knowledge about their condition and treatment options, promoting informed decision-making and adherence to treatment plans. Collecting PROMs allows for real-time monitoring of patient health and treatment efficacy, enabling personalized care adjustments. These mechanisms collectively improve patient engagement by ensuring patients are well-informed, supported, and actively involved in their care.

Participants' uptake of clinical trial results: a randomised experiment.