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

Trial Summary

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 data supports the effectiveness of the BC-Navigate treatment for breast cancer?

Research shows that patient navigation, which helps guide patients through their cancer treatment, can improve outcomes by reducing barriers and ensuring timely access to care. The BC-Navigate app aims to provide similar support by offering education, symptom tracking, and trial matching, which may enhance the care experience for breast cancer patients. ^{1 2 3 4 5}

Is the BC-Navigate App safe for use in humans?

The available research does not provide specific safety data for the BC-Navigate App, but similar mobile apps for breast cancer patients have been used to track symptoms and manage care without reported safety issues. ^{1 2 4 6 7}

How is the BC-Navigate treatment different from other breast cancer treatments?

The BC-Navigate App is unique because it is a mobile health application designed to assist patient navigators in supporting breast cancer patients, focusing on improving care coordination and patient engagement, unlike traditional treatments that primarily focus on medical interventions. ^{4 8 9 10 11}

What is the purpose of this trial?

The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment. TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program. 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 improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). [2023]

2. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

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

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. [2019]

4. Netherlands 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. [2023]

5. Canada 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. [2023]

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

Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. [2022]

7. Canada 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. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Content, Usability, and Utilization of Plain Language in Breast Cancer Mobile Phone Apps: A Systematic Analysis. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

A biopsy of Breast Cancer mobile applications: state of the practice review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

BECCA. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Smartphone breast applications - what's the evidence? [2022]