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RecruitingInterventional

The Patient Care Outreach, Navigation, Technology and Support 2.0 Study

NCT ID: NCT06648278Sponsor: University of California, San FranciscoLast updated: 2026-01-13

Summary

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.

Detailed description

Patient COUNTS 2.0 aims to improve and scale up the current Patient COUNTS program. PRIMARY OBJECTIVES: I. Identify underserved individuals who speak English, Chinese or Spanish and were diagnosed with breast cancer or cardiovascular disease through collaboration with Zuckerberg San Francisco General Hospital (ZSFG), University of California, San Francisco clinics (Athena), University of California, San Francisco registries (via medical chart review), San Francisco State University, and other community organization collaborators. II. Conduct outreach to potential participants to let them know about the availability of virtual patient navigation via the Patient Care Outreach, Navigation, Technology and Support (COUNTS) web portal, and the Patient COUNTS patient navigation program (NCT03867916). III. Provide patient navigation virtually. OUTLINE: The patient COUNTS portal will be available in English and expanded to include content in Chinese and Spanish. An initial cohort of focus group of 15 breast cancer patients, 5 navigators, social workers, caregivers or other person involved in breast cancer care will help develop the culturally and language specific components of the COUNTS program. Following implementation, breast cancer participants and cardiovascular participants will participate in an online navigation program along with family members of the patient community will be enrolled. Participants will use the online COUNTS portal to access navigation program and may choose to have online/virtual navigation support or in-person navigation support. Participants also 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.

Arms & interventions

  • BehavioralPatient Navigation Program

    Online health tool

  • OtherQuality-of-Life (QOL) Assessment

    Online surveys to assess QOL

  • OtherSurvey Administration

    Ancillary studies

Outcome measures

Primary

  • Proportion of participants who reported satisfaction with COUNTS program

    Participant satisfaction will be assessed via a response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program

    Time frame: Up to 6 months

  • Rate of Participation

    Participation is defined as having at least one contact with patient navigator

    Time frame: Up to 6 months

  • Utilization rate

    Utilization is defined as the number of interactions with the patient navigator

    Time frame: Up to 6 months

Secondary

  • Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B)

    Time frame: Up to 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: For Focus groups: * Breast cancer patients: Diagnosed with breast cancer, ages 18 or older, speaks English, Mandarin/Cantonese, or Spanish * Navigators: any patient navigator who has provided care to underserved populations diagnosed with cancer For Portal Implementation phase: * Ages 18 or older * Speaks English, Mandarin/Cantonese, Spanish, * Has any stage breast cancer * Has access to a phone that is able to receive text messages, is willing to stay in the study for six-seven months. Family User experience survey: * Family member or friend who may have assisted breast cancer participant with registration, accessing or otherwise assisting breast cancer family member or friend participant with the online portal. Exclusion Criteria: * Any medical or psychological conditions precluding informed consent

Study locations (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110

Recruiting
Laura Allen · Contact

University of California, San Francisco

San Francisco, California, 94143

Recruiting
Laura Allen · Contact
Scarlett L Gomez, PhD · Principal Investigator