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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
