Patient Care Outreach, Navigation, Technology and Support 2.0
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Navigation Program, Quality-of-Life (QOL) Assessment, Survey Administration.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cardiovascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Patient Care Outreach, Navigation, Technology and Support 2.0 Study
Overview
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.
Interventions
- Behavioral Patient Navigation Program
Online health tool - Other Quality-of-Life (QOL) Assessment
Online surveys to assess QOL - Other Survey Administration
Ancillary studies
Primary outcome measures
- Proportion of participants who reported satisfaction with COUNTS program [Time frame: Up to 6 months]
- Rate of Participation [Time frame: Up to 6 months]
- Utilization rate [Time frame: Up to 6 months]
Secondary outcome measures (1)
- Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B) [Time frame: Up to 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Zuckerberg San Francisco General Hospital — San Francisco
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06648278 · 22054 · NCI-2024-08188