Patient Care Outreach, Navigation, Technology and Support 2.0

NCT06648278 | Recruiting

• 2 other identifiers: 22054NCI-2024-08188
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Cardiovascular Diseases

Keywords

Health Services

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

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

  Up to 6 months

Study Arms (1)

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.

Behavioral: Patient Navigation Program; Other: Quality-of-Life (QOL) Assessment; Other: Survey Administration

Interventions

Quality-of-Life (QOL) Assessment OTHER

Online surveys to assess QOL

Also known as: QOL Assessment, QOL Survey

Health services research (Patient COUNTS2)

Survey Administration OTHER

Ancillary studies

Also known as: Experience Survey

Health services research (Patient COUNTS2)

Patient Navigation Program BEHAVIORAL

Online health tool

Also known as: Patient Navigator Program

Health services research (Patient COUNTS2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any medical or psychological conditions precluding informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cardiovascular Diseases

Interventions

Patient Navigation; Quality of Life; Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Scarlett L Gomez, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Allen

CONTACT

415-818-7143; Laura.Allen@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: August 10, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)