E-Health Solutions for Breast Cancer

(ABODE Trial)

Overseen By Emma Reel, MSW

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Males, Non-operable cancer, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 13 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help women newly diagnosed with breast cancer manage their care from home. The app, part of the At-home Breast Oncology Care Delivered With E-health Solutions (ABODE Study or Breast Cancer Treatment Application), will be used alongside standard care to determine if it improves patient engagement and health outcomes. Participants will either use the app or receive regular care, enabling researchers to compare experiences and results. Women recently diagnosed with their first invasive breast cancer and preparing for surgery might be suitable for this trial, especially if they have internet access and can communicate in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could enhance patient experiences and outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this eHealth solution is safe for breast cancer patients?

Research shows that eHealth tools, such as the Breast Cancer Treatment Application (BCTA), can enhance patient care without causing harm. This app provides virtual consultations and educational resources, avoiding medications or physical treatments that might have side effects.

The BCTA app supports patients during their breast cancer journey by facilitating connections with healthcare providers and offering valuable information. In similar situations, patients have reported positive experiences with these digital health tools, noting improved understanding of their condition and increased involvement in their care.

As part of a study and not a drug or invasive treatment, the app presents no safety concerns like those associated with new medications. It focuses on improving communication and access to information, which is crucial for quality healthcare but unlikely to pose safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about E-health solutions for breast cancer because they integrate technology into patient care, potentially transforming how treatment is delivered. Unlike traditional in-person visits and chemotherapy, the study treatment uses the Breast Cancer Treatment Application (BCTA), allowing patients to receive care at home. This digital approach offers continuous monitoring and support, making treatment more accessible and personalized. By enhancing patient engagement and convenience, this method could lead to better treatment adherence and improved quality of life.

What evidence suggests that this eHealth solution is effective for breast cancer care?

Research has shown that eHealth tools, such as the Breast Cancer Treatment App, can improve patient outcomes by making healthcare more accessible and personalized. Early results suggest that healthcare apps can increase patient involvement in their care. This trial will compare two groups: one will receive standard care, while the other will receive standard care plus access to the Breast Cancer Treatment Application (BCTA) for 13 months. The app enables virtual doctor visits and provides educational resources, helping patients better manage their health. The goal is to determine if the app enhances patients' confidence in managing their condition compared to those receiving only standard care. ^{1 2 3 4 5}

Who Is on the Research Team?

Tulin Cil, MD, MEd

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman diagnosed with my first invasive breast cancer.

Access to an electronic device with connection to the internet

I can communicate in English and understand the difference between sex and gender.

Exclusion Criteria

My breast cancer cannot be removed with surgery.

I have hearing or visual challenges.

My cancer is at stage 4 or has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months

13 months

Regular virtual consultations via the app

Follow-up

Participants are monitored for changes in patient activation and other outcomes at 6 and 12 months post-diagnosis

12 months

3 visits (virtual) at baseline, 6 months, and 12 months

Extension

Participants may continue to use the app for ongoing monitoring and support

Optional extension beyond 13 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

The control arm will receive standard treatment.

At-home Breast Oncology Care Delivered With E-health Solutions is already approved in Canada for the following indications:

Approved in Canada as ABODE Study for:

• Breast cancer management and support

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

eHealth interventions significantly improve quality of life, self-efficacy, and reduce distress and fatigue in breast cancer patients, based on a systematic review of 32 studies involving 4,790 patients.

These interventions are generally well-accepted by patients, with high satisfaction and usefulness ratings, although engagement tends to decrease over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses. Singleton, AC., Raeside, R., Hyun, KK., et al.[2023]

The pilot study involving 94 breast cancer patients aims to assess the feasibility and acceptability of a nurse-led mHealth program (mChemotherapy) designed to enhance self-management during chemotherapy, particularly during the challenges posed by the pandemic.

If effective, the mChemotherapy program could significantly improve patients' self-efficacy and adherence to app usage, helping them better manage chemotherapy side effects and take an active role in their health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nurse-Led mHealth Self-Management Program (mChemotherapy) for Breast Cancer Patients Undergoing Chemotherapy: Study Protocol of a Randomized Controlled Pilot Study. Shi, N., Wong, AKC., Wong, FKY., et al.[2022]

Telehealth is generally accepted by women undergoing treatment for breast cancer, providing a way to maintain continuity of care, especially for those in remote locations.

Patients expressed a need for improvements in the structure, usability, and interaction with health professionals during telehealth consultations, highlighting areas for enhancement in this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Women With Breast Cancer Using Telehealth: A Qualitative Systematic Review. Meneses, AFP., Pimentel, FF., da Cruz, JPF., et al.[2023]

The Breast Cancer e-Support mobile app is designed to improve self-efficacy, social support, and symptom management for women undergoing chemotherapy, with a study involving 108 participants to assess its effectiveness over 6 months.

This study is the first in China to rigorously evaluate a mobile app intervention for breast cancer patients, aiming to enhance their quality of life and psychological well-being through tailored support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. Zhu, J., Ebert, L., Liu, X., et al.[2022]

A pragmatic trial involving 2158 patients with early stage breast cancer found that remote proactive management of chemotherapy-related toxicities did not significantly reduce emergency department visits or hospital admissions compared to routine care.

While the intervention group reported slightly fewer grade 3 toxicities (48%) than the control group (58%), there were no significant differences in self-efficacy, anxiety, or depression, indicating that the remote management approach may not improve overall patient outcomes during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. Krzyzanowska, MK., Julian, JA., Gu, CS., et al.[2021]

The WEBAPPAC trial is a phase 3 study involving 438 breast cancer patients that aims to evaluate the effectiveness of a web-application in improving adherence to hormone therapy, which is crucial for reducing the risk of disease recurrence.

The study will assess not only adherence rates but also the management of adverse drug reactions and overall quality of life, highlighting the importance of patient support in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study. Gernier, F., Grellard, JM., Dupont, C., et al.[2023]

The pilot study involving 23 female breast cancer survivors demonstrated that an app-based interactive care plan (ICP) was feasible, allowing for remote monitoring and symptom management, although patient engagement fell short of the desired 75% completion rate for tasks.

Despite the initial feasibility, with all patients engaging in at least one task, the decreasing completion rates over time indicate a need for strategies to improve ongoing patient engagement and enhance the effectiveness of the ICP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. Stan, DL., Inselman, JW., Ridgeway, JL., et al.[2022]

Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.

This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

The ConnectedCancerCare (CCC) intervention was found to be feasible and acceptable for women with early-stage breast cancer, with 82% of participants finding it easy to use and 86% willing to recommend it to others.

Women using CCC were more likely to schedule follow-up visits with their primary care provider and had better communication about provider roles, indicating that CCC may enhance patient engagement and knowledge in team-based cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. Wallner, LP., Abrahamse, P., Gargaro, JG., et al.[2023]

The eHealth system CHESS was effectively utilized by low-income women with breast cancer, with participants logging on and spending more time using the system compared to more affluent users in previous studies.

Women using CHESS showed significant improvements in social support, negative emotions, participation in healthcare, and information competence compared to a control group, indicating that eHealth interventions can positively impact the quality of life for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and Impact of eHealth System by Low-income Women With Breast Cancer. Gustafson, DH., McTavish, FM., Stengle, W., et al.[2018]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

Remote patient monitoring software (RPMS) in oncology care significantly improves health-related quality of life and reduces physical symptom burden during cancer treatment, based on a review of nine randomized controlled trials.

The effectiveness of RPMS is enhanced when integrated into routine clinical care, particularly with nurses involved in remote monitoring, indicating that this model can be a valuable addition to standard cancer care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Patient-Reported Outcome Tracking and Health Information Provision via Remote Patient Monitoring Software on Patient Outcomes in Oncology Care: A Systematic Review and Meta-Analysis. Wang, T., Ho, MH., Tong, MCF., et al.[2023]

Oncology nurses in rural Norway found that using video conferencing (VC) for follow-up care improved accessibility and allowed for more frequent patient contact, enhancing the quality of care provided.

The study highlights the importance of tailoring virtual care to individual patient needs, suggesting that while VC can reduce travel time for nurses, its appropriateness should be assessed in complex cancer care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology nurses' lived experiences of video communication in follow-up care of home-living patients: A phenomenological study in rural Norway. Rygg, LØ., Brataas, HV., Nordtug, B.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40345693/

At-home Breast Oncology care Delivered with EHealth ... This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada.

2. bmjopen.bmj.com bmjopen.bmj.com/content/15/5/e091579

At-home Breast Oncology care Delivered with EHealth ... This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05989477

At-home Breast Oncology Care Delivered With E-health ... The ABODE study involved development of a Breast Cancer Treatment Application (app) which will facilitate virtual consultations, deliver patient education ...

4. researchgate.net researchgate.net/publication/391593684_At-home_Breast_Oncology_care_Delivered_with_EHealth_solutions_ABODE_study_protocol_a_randomised_controlled_trial

At-home Breast Oncology care Delivered with EHealth ... Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health ...

5. semanticscholar.org semanticscholar.org/paper/723c643aec0f7235634e175ddb57a3e6fcb788db

At-home Breast Oncology care Delivered with EHealth solutions ... Among newly diagnosed patients with breast cancer, this randomised controlled trial will compare changes in patient activation, other patient-reported ...