Virtual Patient Navigation for Breast Cancer

(COUNTS2 Trial)

Not currently recruiting at 1 trial location

Overseen By Laura Allen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Medical, psychological conditions, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a virtual patient navigation program can assist individuals with breast cancer or heart disease in managing their care. It aims to simplify healthcare navigation for underserved English, Chinese, or Spanish speakers. Participants will use an online portal to access navigation services and provide feedback to enhance the program. The study seeks breast cancer patients who have a phone capable of receiving text messages and are willing to participate for approximately six to seven months. As an unphased trial, it offers participants the chance to contribute to innovative solutions that could simplify healthcare navigation for diverse communities.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual patient navigation program is safe for underserved individuals with breast cancer or cardiovascular disease?

Research has shown that patient navigation programs are generally safe and well-received. These programs guide patients through their healthcare journey, increasing cancer screening rates and helping them adhere to treatment plans. Studies have found that these programs can enhance patients' quality of life and satisfaction with their care.

No evidence suggests that virtual patient navigation, the focus of this trial, causes any physical side effects. Instead, it aims to make healthcare more accessible to underserved communities by using technology to connect patients with healthcare support. This approach helps overcome barriers like language and location, ensuring more people receive the care they need.

Overall, patient navigation is considered safe and beneficial, making it a promising option for improving healthcare access and outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Patient Navigation program for breast cancer because it offers personalized support that goes beyond the typical medical treatments. Unlike standard options, which mainly focus on surgery, chemotherapy, and radiation, this program helps patients navigate the healthcare system, understand their treatment choices, and access necessary resources through a user-friendly web portal. By participating in focus groups and completing surveys, patients contribute to enhancing the program, potentially improving care and support for diverse patient groups. This approach not only aims to empower patients but also to streamline their cancer journey, making it less overwhelming and more informed.

What evidence suggests that virtual patient navigation is effective for breast cancer?

Studies have shown that patient navigation programs improve access to cancer care. Research indicates these programs reduce obstacles and ease patient support throughout treatment. In this trial, participants will engage with a virtual patient navigation program. Early findings suggest that virtual patient navigation, especially when available in multiple languages, effectively reaches underserved communities, such as those speaking English, Chinese, or Spanish. This approach helps ensure fairer outcomes by connecting patients with necessary care. These programs have successfully improved healthcare access, particularly for vulnerable groups facing breast cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Scarlett L Gomez, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for underserved individuals diagnosed with breast cancer who speak English, Chinese, or Spanish. It aims to test the usability of a virtual patient navigation portal designed to support people in these communities.

Exclusion Criteria

Any medical or psychological conditions precluding informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group Development

Initial cohort of focus group participants help develop culturally and language-specific components of the COUNTS program

4 weeks

1-2 visits (virtual or in-person)

Navigation Program

Participants use the online COUNTS portal for navigation support and complete data collection and surveys

6 months

Ongoing virtual interactions

Follow-up

Participants complete a user experience survey at the end of program participation

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation Program

Trial Overview The study is testing a virtual patient navigation program combined with survey administration and quality-of-life assessments. The goal is to see if this online approach can effectively extend support services to more patients.

How Is the Trial Designed?

Group I: Health services research (Patient COUNTS2) Experimental Treatment 3 Interventions

Participants attend focus groups to help further develop the patient portal and navigation program to expand to other groups. Participants use in-person navigation program and complete data collection and surveys over 15 minutes via web portal at baseline and 6 months and user experience survey at end of program participation.

Patient Navigation Program is already approved in United States for the following indications:

Approved in United States as Patient Navigation Program for:

• Support for breast cancer patients in underserved communities

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The original patient navigation programs effectively combined community involvement and culturally sensitive care coordination to address disparities in cancer care, particularly for racial and ethnic minorities.

These programs functioned as a system rather than relying on individual navigators, with a structured team of navigators and directors working together to remove barriers and facilitate patient access to care, highlighting the importance of administrative support and community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Vargas, RB., Ryan, GW., Jackson, CA., et al.[2011]

The implementation of nurse navigation at a comprehensive breast center significantly reduced the time to initial oncology consultation for breast cancer patients over 60 years old, improving timely care after diagnosis.

In contrast, younger patients (ages 31 to 60) did not experience any change in consultation timeliness, indicating that nurse navigation may be more beneficial for older patients in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of nurse navigation on timeliness of breast cancer care at an academic comprehensive cancer center. Basu, M., Linebarger, J., Gabram, SG., et al.[2013]

In a pilot study of 100 African American breast cancer patients, those who received patient navigation promoted breast cancer screening to more individuals in their social networks compared to those who did not receive navigation.

The study suggests that navigated patients not only increased awareness of breast cancer screening among their contacts but also potentially led to higher screening rates among their network members, indicating a broader impact of patient navigation on community health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigated African American breast cancer patients as incidental change agents in their family/friend networks. Molina, Y., Strayhorn, SM., Bergeron, NQ., et al.[2023]

Patient navigation (PN) was successfully implemented in resident clinics, leading to a significant increase in biennial screening mammography adherence among patients, particularly in vulnerable populations.

Residents expressed satisfaction with the PN process and showed interest in continuing its use, indicating that PN is a feasible and effective intervention in improving cancer screening rates in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. Shroff, S., McCoy, ME., Sherman, BJ., et al.[2016]

A study assessing patient navigation programs at six Boston hospitals revealed significant variability in how these programs are structured and implemented, affecting their effectiveness in supporting breast cancer patients.

Despite all hospitals offering navigation services, inconsistencies in funding, targeted patient populations, and the continuity of services highlight critical gaps that could be addressed to improve care and reduce disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. LeClair, AM., Battaglia, TA., Casanova, NL., et al.[2022]

A patient navigation (PN) program significantly improved follow-up care for disadvantaged women with abnormal mammograms, with 90.4% receiving appropriate follow-up compared to 75.3% in practices without PN.

Women in the PN program also experienced quicker follow-up times, especially for BI-RADS 3 findings, where the likelihood of timely follow-up was more than double compared to non-PN practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. Percac-Lima, S., Ashburner, JM., McCarthy, AM., et al.[2018]

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 involving 3,189 patients (1,995 with breast abnormalities and 1,194 with cervical abnormalities), the presence of barriers significantly delayed the time to diagnostic resolution, with adjusted hazard ratios of 0.744 for breast and 0.792 for cervical participants, indicating that barriers negatively impact timely care.

Patient navigators played a crucial role in addressing these barriers by arranging appointments, making referrals, and providing education, suggesting that effective navigation can enhance access to cancer care and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. Katz, ML., Young, GS., Reiter, PL., et al.[2021]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06648278

Patient Care Outreach, Navigation, Technology and Support 2.0 This is a feasibility study employing virtual patient navigation for underserved individuals who speak English, Chinese or Spanish and were diagnosed with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11459495/

Impact of Virtual Navigation on the Education and Access ... This study explores a unique role that virtual navigation may play in helping accommodate healthcare for many cancer patients in underserved areas.

3. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/achieving-equity-cancer-care

Part I. Achieving Equity in Cancer Care: The Need for ... The aim of patient navigation is to reduce barriers and facilitate a patient's access to care by providing needed support services throughout the cancer ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...

5. uicc.org uicc.org/news-and-updates/blog/equitable-outcomes-people-breast-cancer-through-patient-navigation

Equitable outcomes for people with breast cancer through ... The PCC's data reinforces the efficacy of an easily accessible bilingual telehealth model, as it effectively reaches out to the most vulnerable ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317281/

Implementation of a Patient Navigation Program to Support ... Navigation programs increase cancer screening rates, treatment adherence, quality of life, and satisfaction with care, improve cancer outcomes, ...

7. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Patient navigation services are provided by healthcare systems to help patients overcome barriers to cancer screening and follow-up as they move ...

8. accc-cancer.org accc-cancer.org/home/learn/comprehensive-cancer-care-services/patient-navigation

Patient Navigation This program delivers intensive hospital-level care to eligible patients in their own homes through a care team that includes oncology nurse practitioners, home ...