Virtual Patient Navigation for Breast Cancer

(COUNTS2 Trial)

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

260 Participants Needed

Trial Summary

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 data supports the idea that Virtual Patient Navigation for Breast Cancer is an effective treatment?

The available research shows that Virtual Patient Navigation helps improve breast cancer care by reducing barriers and ensuring timely access to treatment. For example, it has been effective in speeding up the time from positive screening tests to diagnosis and treatment initiation. This is particularly beneficial for disadvantaged women, as it helps them follow up on abnormal mammograms more effectively. While disparities in outcomes still exist, the use of patient navigation programs in hospitals has been shown to improve care for those at risk of delays. ^{1 2 3 4 5}

What safety data exists for Virtual Patient Navigation in breast cancer treatment?

The provided research does not directly address safety data for Virtual Patient Navigation in breast cancer treatment. The studies focus on the efficacy, feasibility, and broader impacts of patient navigation programs, but do not specifically evaluate safety outcomes or adverse events related to these interventions. ^{1 6 7 8 9}

Is the Patient Navigation Program a promising treatment for breast cancer?

Yes, the Patient Navigation Program is a promising treatment for breast cancer. It helps patients by reducing barriers to care, improving timely access to treatment, and increasing adherence to screening. It also supports patients in understanding their treatment and can positively impact their family and friends by spreading important health information. ^{1 6 7 8 10}

What is the purpose of this trial?

This is a feasibility study employing virtual patient navigation for underserved individuals who speak English, Chinese or Spanish and were diagnosed with breast cancer or cardiovascular disease to determine the extent of usability for a virtual patient navigation portal serving people in underserved communities. While not able to entirely replace in-person interactions, virtual patient navigation may be used to expand reach and availability of navigation services to a much greater segment of the population.

Research Team

Scarlett L Gomez, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 (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]

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]

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]

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]

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]

References

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

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

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Assessment of patient navigation programs for breast cancer patients across the city of Boston. [2022]

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

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]

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

Feasibility of patient navigation in resident primary care practice: a screening mammography quality improvement initiative. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

Navigated African American breast cancer patients as incidental change agents in their family/friend networks. [2023]

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

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. [2011]

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

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

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

The effect of nurse navigation on timeliness of breast cancer care at an academic comprehensive cancer center. [2013]