Breast CancerCOUNTS2NCT06648278
Patient Care Outreach, Navigation, Technology and Support 2.0
A study testing Patient Navigation Program, Quality-of-Life (QOL) Assessment and Survey Administration in people with Breast Cancer and Cardiovascular Diseases, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cardiovascular Diseases
- What is being tested?
- Patient Navigation Program, Quality-of-Life (QOL) Assessment and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- Any medical or psychological conditions precluding informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Laura Allen, 415-818-7143, Laura.Allen@ucsf.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Laura Allen, 415-818-7143, Laura.Allen@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: The Patient Care Outreach, Navigation, Technology and Support 2.0 Study
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.
Read the detailed description
Patient COUNTS 2.0 aims to improve and scale up the current Patient COUNTS program.
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Cancer, Cardiovascular Diseases
- Being tested
- Patient Navigation Program, Quality-of-Life (QOL) Assessment, Survey Administration
- Keywords
- Health Services
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation ProgramBehavioural
Also called Patient Navigator Program
Online health tool
Quality-of-Life (QOL) AssessmentOther
Also called QOL Assessment, QOL Survey
Online surveys to assess QOL
Survey AdministrationOther
Also called Experience Survey
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient Navigation Program; Other: Quality-of-Life (QOL) Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Rate of Participation
Participation is defined as having at least one contact with patient navigator
Measured: Up to 6 months
Utilization rate
Utilization is defined as the number of interactions with the patient navigator
Measured: Up to 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start10 Aug 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scarlett L Gomez, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648278
- Sponsor's protocol ID
- 22054
- Other IDs
- NCI-2024-08188
- Acronym
- COUNTS2
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Care Outreach, Navigation, Technology and Support 2.0 Study
- ClinicalTrials.gov ID
- NCT06648278
- Acronym / sponsor ID
- COUNTS2 / 22054
- Conditions
- Breast Cancer, Cardiovascular Diseases
- Keywords
- Health Services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (Patient COUNTS2) | Experimental | Behavioral: Patient Navigation Program, Other: Quality-of-Life (QOL) Assessment, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Ages 18 or older
- Speaks English, Mandarin/Cantonese, Spanish,
- Has any stage breast cancer
Key exclusion criteria (1 listed)
- Any medical or psychological conditions precluding informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigation ProgramAlso: Patient Navigator ProgramOnline health tool | Behavioural | Health services research (Patient COUNTS2) |
| Quality-of-Life (QOL) AssessmentAlso: QOL Assessment, QOL SurveyOnline surveys to assess QOL | Other | Health services research (Patient COUNTS2) |
| Survey AdministrationAlso: Experience SurveyAncillary studies | Other | Health services research (Patient COUNTS2) |
Primary outcome
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
1 secondary outcome
Mean scores on the Functional Assessment of Cancer Therapy- Breast (FACT-B)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scarlett L Gomez, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program, Quality-of-Life (QOL) Assessment and Survey Administration in people with Breast Cancer and Cardiovascular Diseases, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Allen (415-818-7143, Laura.Allen@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who reported satisfaction with COUNTS program (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.