Clinical trial NCT06648278: Patient Care Outreach, Navigation, Technology and Support 2.0
Official title: The Patient Care Outreach, Navigation, Technology and Support 2.0 Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Cancer
Cardiovascular Diseases
Keywords: Health Services
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Proportion of participants who reported satisfaction with COUNTS program
timeFrame: Up to 6 months
measure: Rate of Participation
timeFrame: Up to 6 months
measure: Utilization rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Scarlett L Gomez, PhD
role: PRINCIPAL_INVESTIGATOR
References: