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Clinical Trials/NCT06648278
NCT06648278
Recruiting
N/A

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

University of California, San Francisco2 sites in 1 country260 target enrollmentAugust 10, 2023

Overview

Phase
N/A
Intervention
Patient Navigation Program
Conditions
Not specified
Sponsor
University of California, San Francisco
Enrollment
260
Locations
2
Primary Endpoint
Proportion of participants who reported satisfaction with COUNTS program
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2023
End Date
February 28, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Health services research (Patient COUNTS2)

Participants attend focus groups to help further develop the patient portal and navigation program to expand to other groups. Participants use in-person navigation program and 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.

Intervention: Patient Navigation Program

Health services research (Patient COUNTS2)

Participants attend focus groups to help further develop the patient portal and navigation program to expand to other groups. Participants use in-person navigation program and 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.

Intervention: Quality-of-Life (QOL) Assessment

Health services research (Patient COUNTS2)

Participants attend focus groups to help further develop the patient portal and navigation program to expand to other groups. Participants use in-person navigation program and 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.

Intervention: Survey Administration

Outcomes

Primary Outcomes

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

Rate of Participation

Time Frame: Up to 6 months

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

Utilization rate

Time Frame: Up to 6 months

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

Secondary Outcomes

  • Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B)(Up to 6 months)

Study Sites (2)

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