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NCT Number: 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 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation Program

Behavioral

Online health tool

Other names: Patient Navigator Program

Quality-of-Life (QOL) Assessment

Other

Online surveys to assess QOL

Other names: QOL Assessment, QOL Survey

Survey Administration

Other

Ancillary studies

Other names: Experience Survey

Primary outcomes

  1. Proportion of participants who reported satisfaction with COUNTS program

    Time frame: Up to 6 months

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

  2. Rate of Participation

    Time frame: Up to 6 months

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

  3. Utilization rate

    Time frame: Up to 6 months

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

Secondary outcomes

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

    Time frame: Up to 6 months

    The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Allen

CONTACT

[email protected]

415-818-7143

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: COUNTS2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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