E-Health Solutions for Breast Cancer

(ABODE Trial)

Overseen by Tulin Cil, MD, MEd

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment At-home Breast Oncology Care Delivered With E-health Solutions (ABODE Study)?

Research shows that eHealth systems like CHESS have a positive impact on low-income women with breast cancer, improving social support, reducing negative emotions, and enhancing participation in health care. Additionally, mobile applications providing tailored information and support have been shown to improve quality of life and psychological well-being for women undergoing breast cancer treatment. ^{1 2 3 4 5}

Is the E-Health Solutions for Breast Cancer treatment safe for humans?

The research on E-Health Solutions for Breast Cancer, including web applications and app-based care plans, focuses on improving treatment adherence and managing side effects, but does not provide specific safety data. However, these digital tools are designed to support existing treatments, which have known safety profiles. ^{6 7 8 9 10}

How is the ABODE Study treatment different from other breast cancer treatments?

The ABODE Study treatment is unique because it uses e-health solutions to provide at-home care for breast cancer patients, offering personalized support and information through a mobile application, which can improve self-management, social support, and quality of life compared to traditional in-person care. ^{2 3 11 12 13}

Research Team

Tulin Cil, MD, MEd

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• At-home Breast Oncology Care Delivered With E-health Solutions (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Findings from Research

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]

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 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]

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 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]

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 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 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]

References

1. Scotland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Use and Impact of eHealth System by Low-income Women With Breast Cancer. [2018]

3. England 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. [2022]

4. Netherlands 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. [2023]

5. United States 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. [2023]

6. England 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. [2023]

7. England 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. [2021]

8. United States 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. [2022]

9. Canada 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. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses. [2023]

12. United States 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Experiences of Women With Breast Cancer Using Telehealth: A Qualitative Systematic Review. [2023]