Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Patient Care Outreach, Navigation, Technology and Support (COUNTS) 2.0

Official title: The Patient Care Outreach, Navigation, Technology and Support 2.0 Study

Run by University of California, San Francisco · NCT06648278 · Data updated 2026-11-12

This project will test a multilingual virtual patient navigation portal to help English-, Chinese-, and Spanish-speaking adults with breast cancer or cardiovascular disease in underserved communities.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment260 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations2 sites (San Francisco, California and 1 other locations)
StatusRecruiting
StartedAugust 10, 2023
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2027
Registry record updatedJanuary 13, 2026
Trial IDNCT06648278 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (18+) diagnosed with any stage breast cancer or with cardiovascular disease who speak English, Mandarin/Cantonese, or Spanish, are connected to UCSF/ZSFG or partner outreach channels, and have access to a phone that can receive text messages.

Probably not a fit

Patients without reliable phone or internet access, those who cannot provide informed consent for medical or psychological reasons, or those who require only in-person navigation may not benefit from this virtual program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

COUNTS 2.0 builds on an existing patient navigation program by expanding an online portal and materials into Chinese and Spanish and testing usability in underserved communities. The team will recruit participants through UCSF clinics, registries, Zuckerberg San Francisco General, and community partners, using focus groups with patients, navigators, caregivers, and social workers to refine culturally specific content. Enrolled participants and family members will use the web portal and receive virtual navigation, complete quality-of-life assessments and surveys, and receive outreach messages over a six-to-seven month follow-up. The study is primarily a feasibility and implementation effort to determine reach, acceptability, and practical barriers to wider rollout.

Why it matters

Potential benefit: If successful, this could expand access to culturally and linguistically appropriate navigation services for underserved patients, improving care coordination and access to resources.

How similar studies have gone: Earlier navigation programs, including the original Patient COUNTS, have shown promise in supporting underserved patients, but fully virtual, multilingual portal implementations remain less tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Zuckerberg San Francisco General Hospital
    San Francisco, California, United States
    Recruiting
  • University of California, San Francisco
    San Francisco, California, United States
    Recruiting

Study contacts

  • Principal investigator: Scarlett L Gomez, PhD — University of California, San Francisco
  • Study coordinator: Laura Allen
  • Email: Laura.Allen@ucsf.edu
  • Phone: 415-818-7143

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.