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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-08188 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (Patient COUNTS2) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation Program | Behavioral | Online health tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who reported satisfaction with COUNTS program | Participant satisfaction will be assessed via a response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program | Up to 6 months |
| Rate of Participation | Participation is defined as having at least one contact with patient navigator | Up to 6 months |
| Utilization rate | Utilization is defined as the number of interactions with the patient navigator | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B) | 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. |
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Inclusion Criteria:
For Focus groups:
For Portal Implementation phase:
Family User experience survey:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Allen | Contact | 415-818-7143 | Laura.Allen@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scarlett L Gomez, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| D011788 | Quality of Life |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Quality-of-Life (QOL) Assessment | Other | Online surveys to assess QOL |
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| Survey Administration | Other | Ancillary studies |
|
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| Up to 6 months |
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006298 | Health Services Administration |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |