BC-Navigate App for Breast Cancer

Overseen By Alma Diaz

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Men, End-stage renal disease, Heart failure, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new app called BC-Navigate, designed to guide women during breast cancer treatment. The goal is to improve the speed at which women of color begin their recommended chemotherapy after surgery. Women recently diagnosed with non-metastatic breast cancer who have not yet started chemotherapy may be suitable candidates. Participants must have internet access and receive care at Northwestern Medicine. The trial aims to determine if this app makes navigating treatment easier and more effective. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment experiences for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that the BC-Navigate app is safe for use in breast cancer care?

Research has shown that the BC-Navigate app is designed to help women manage their breast cancer treatment by offering guidance and support. As a digital tool, not a medication or medical procedure, it poses no direct safety risks.

Users might encounter technical issues or find the app less helpful than expected. However, there are no physical side effects since it is an app, not a drug.

The app aims to help women begin their treatment more quickly and effectively. By focusing on support and education, it helps users feel more informed and confident without the risks associated with other types of treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for breast cancer, which usually focus on medication or chemotherapy, the BC-Navigate app is a digital tool designed to improve patient experiences and outcomes. Researchers are excited about this app because it offers personalized patient navigation and coaching through a mobile platform, aiming to help diverse breast cancer patients start their chemotherapy treatments more promptly. This approach is unique because it leverages technology to enhance communication and support, potentially bridging gaps in healthcare access and ensuring patients receive timely care.

What evidence suggests that the BC-Navigate app is effective for breast cancer care?

Research has shown that patient navigation programs can improve care and health outcomes for breast cancer patients. This trial tests the BC-Navigate app as an experimental tool to assist women, particularly women of color, during their breast cancer treatment by providing guidance and resources. Early findings suggest that such tools can help patients start their treatments sooner and remain on track. By increasing knowledge and self-advocacy, the BC-Navigate app aims to reduce health disparities in cancer care. Although specific clinical data for this app is limited, similar programs have shown promise in helping patients initiate and adhere to their treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women of color with breast cancer, focusing on Black and African American individuals. Participants should be receiving care at Northwestern's breast cancer program and willing to use the BC-Navigate website/app for guidance during treatment.

Inclusion Criteria

My breast cancer is in stages I-III and has not spread to distant parts of my body.

A specialist has scheduled me for chemotherapy after surgery.

Access to internet on a smart phone or computer/tablet

Exclusion Criteria

I am a man.

I have a serious health condition that could delay my cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Navigation and Coaching

Participants receive patient navigation and coaching through the BC-Navigate platform to improve timely initiation to adjuvant chemotherapy treatment

12 weeks

Follow-up

Participants are monitored for retention, recruitment, and acceptability of the BC-Navi application

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BC-Navigate

Trial Overview The study tests a patient navigation-and-coaching program provided through the BC-Navigate app, aiming to improve knowledge, self-advocacy, and timely initiation of adjuvant therapy among participants.

How Is the Trial Designed?

Group I: BC-Navi Experimental Treatment 1 Intervention

Apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant chemotherapy treatment among diverse breast cancer patients.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

The Chrysalis Initiative

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

A study involving 33 stakeholders, including patient navigators and breast cancer patients, identified key barriers in patient navigator workflows such as resource limitations, insurance issues, communication challenges, and logistical tasks that hinder effective breast cancer care.

Stakeholders emphasized the importance of user experience and specific app features in a mobile health (mHealth) app, suggesting that these elements could significantly improve patient navigators' ability to provide care to breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of facilitators and barriers to patient navigator core functions with breast cancer patients: Implications for the development of a human-centered mHealth app. Carr, AL., Vinod, N., Farha, P., et al.[2023]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

A review of 101 breast cancer-related mobile apps revealed that while they provide valuable educational content, the majority focus on outdated practices like breast self-examination, which is no longer recommended as a primary screening method.

Most apps did not adhere to usability and health literacy standards, indicating a need for improvement in app design to ensure they are accessible and informative for diverse populations, particularly in areas like survivorship and end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content, Usability, and Utilization of Plain Language in Breast Cancer Mobile Phone Apps: A Systematic Analysis. Ginossar, T., Shah, SF., West, AJ., et al.[2023]

A systematic review identified 599 breast cancer apps from major smartphone app stores, with the majority being free and primarily focused on disease information, management, and awareness.

Most apps lack a solid evidence base, with only 24.54% including usage disclaimers and less than 20% citing references, highlighting the need for expert involvement in app development to ensure safety and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biopsy of Breast Cancer mobile applications: state of the practice review. Giunti, G., Giunta, DH., Guisado-Fernandez, E., et al.[2022]

Out of 185 reviewed healthcare apps related to breast disease, 75.1% focused on breast cancer, but only 14.2% provided evidence-based information and 12.8% involved medical professionals in their development.

Safety concerns were noted in 15.7% of the apps, indicating a significant need for regulation and quality assurance to enhance consumer confidence and promote effective use in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone breast applications - what's the evidence? Mobasheri, MH., Johnston, M., King, D., et al.[2022]

The Outcomes4Me mobile app was successfully integrated into routine breast cancer care, with 60% of the 107 patients engaging with it at least three times over a 12-week period, surpassing the feasibility target of 40%.

Patients reported that the app improved their ability to track symptoms and increased their interest in clinical trial enrollment, indicating potential benefits for patient education and decision-making in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). Isakoff, SJ., Said, MR., Kwak, AH., et al.[2023]

The app developed by Breast Cancer Care is designed to support individuals with breast cancer in adjusting to life after their hospital treatment has concluded.

This initiative highlights the importance of ongoing support and resources for breast cancer survivors to help them navigate their recovery and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BECCA. [2019]

A bidirectional text-message application, BETA-Text, was successfully piloted with 100 breast cancer patients, showing high acceptance rates (98% found it easy to use and 96% helpful for medication adherence).

The application revealed that therapy-related adverse effects (AEs) were more common than previously reported in clinical trials, with 72% of patients experiencing hot flashes and 39% reporting severe AEs that required provider intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. Mougalian, SS., Epstein, LN., Jhaveri, AP., et al.[2022]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

A study is underway to evaluate the effectiveness of a decision support system (DSS) and a machine learning web application designed to improve adherence to oral anticancer treatments in 100 patients with metastatic breast cancer over a 3-month period.

The DSS, named TREAT, includes various sections to support patients and collect predictive variables related to adherence, aiming to enhance patient engagement and ultimately improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Machine Learning Model to Predict Patients' Adherence Behavior and a Decision Support System for Patients With Metastatic Breast Cancer: Protocol for a Randomized Controlled Trial. Masiero, M., Spada, GE., Sanchini, V., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06271356

Study Details | NCT06271356 | Breast Cancer - Navigate BC-Navigate is a website/application to help guide women through care delivery during breast cancer treatment. What is the study measuring? Primary Outcome ...

2. policylab.us policylab.us/clinical-trials/l/conditions/breast-cancer?page=16

Breast Cancer Clinical Trials & Research Studies Near You ... A listing of 428 Breast Cancer clinical trials actively recruiting volunteers for paid trials and research studies in various therapeutic areas.

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06271356?keyword=%22eHealth%22

Breast Cancer - Navigate - Prospective Cohort ~Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924002084

Decision-making process for risk-reducing salpingo ... While RRSO substantially reduces cancer risk, lowering breast cancer risk by up to 56% and ovarian cancer risk by 80% (NCCN, 2024), it also brings challenges ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12049838/

Perceptions, educational expectations and knowledge ... This integrative review investigates perceptions, educational expectations, and knowledge gaps of patients with breast cancer (BC) regarding radiotherapy (RT).

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405632425000137

Review Article Perceptions, educational expectations and ... This integrative review investigates perceptions, educational expectations, and knowledge gaps of patients with breast cancer (BC) regarding radiotherapy (RT).

7. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9UyMTMwsDMx1Dc1MzMwsTCwMQ0FHKSy4xMDM3MTW0MFCKBQCRdhaW

Save Selected Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8145088/

A Breast Cancer Smartphone App to Navigate the Breast ... The links section provides links to reliable breast cancer websites to access several quality information sources (prevention, detection ...