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Trial Title: Patient Care Outreach, Navigation, Technology and Support 2.0

NCT ID: NCT06648278

Condition: Breast Cancer

Conditions: Keywords:
Health Services

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Patient Navigation Program
Description: Online health tool
Arm group label: Health services research (Patient COUNTS2)

Other name: Patient Navigator Program

Intervention type: Other
Intervention name: Quality-of-Life (QOL) Assessment
Description: Online surveys to assess QOL
Arm group label: Health services research (Patient COUNTS2)

Other name: QOL Assessment

Other name: QOL Survey

Intervention type: Other
Intervention name: Survey Administration
Description: Ancillary studies
Arm group label: Health services research (Patient COUNTS2)

Other name: Experience Survey

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 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 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), and 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 20 participants 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, 100 breast cancer patients will participate in an online patient navigation program and 40 family members of breast cancer patients 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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Zuckerberg San Francisco General Hospital

Address:
City: San Francisco
Zip: 94110
Country: United States

Status: Recruiting

Contact:
Last name: Laura Allen

Phone: 415-818-7143
Email: Laura.Allen@ucsf.edu

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Recruiting

Contact:
Last name: Laura Allen

Phone: 415-818-7143
Email: Laura.Allen@ucsf.edu

Contact backup:

Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Investigator:
Last name: Scarlett L Gomez, PhD
Email: Principal Investigator

Start date: August 10, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: University of California, San Francisco
Agency class: Other

Source: University of California, San Francisco

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06648278

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