Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients

January 10, 2023 updated by: University of California, San Francisco

The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer

This phase I/II trial studies how well patient portal and navigation program work in providing information for Asian American cancer patients. Patient portal and navigation program may help to improve the care provided to Asian American cancer patients.This study is offered in the following languages in addition to English: Chinese (Cantonese or Mandarin) and Vietnamese.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Identify Asian American adults newly diagnosed with colorectal, liver, or lung cancer using a population-based cancer registry.

II. Conduct outreach to these patients to let them know about the availability of information on these cancers, the Patient Cancer OUtreach, Navigation, Technology and Support (COUNTS) web portal, and the Patient COUNTS patient navigation program.

III. Provide patient navigation either virtually or in-person.

OUTLINE:

Patients attend focus groups to help develop patient portal and navigation program. Patients use in-person navigation program. In phase II, patients use an online portal to access navigation program and may choose to have online/virtual navigation support or in-person navigation support. Patients also complete data collection and surveys over 15 minutes via web portal at baseline, 3 months, and 6 months and user experience survey at end of program participation.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • FOR INTERVIEWS AND FOCUS GROUPS:

    • Cancer patients: Self-identifies as Asian American, lives in San Francisco, speaks English, Mandarin, Cantonese, or Vietnamese, has a history of cancer of any kind
    • Caregivers: any person age 21 and older who has provided care to an Asian American cancer patient
    • Health professionals: physicians and other health professionals age 21 and older who provide care to Asian American patients with cancer
  • FOR PILOT IMPLEMENTATION:

    • Self-identifies as Asian American
    • Ages 21 or older
    • Lives in the 9 counties of the greater bay area cancer registry (GBACR)
    • Speaks English, Mandarin, Cantonese, or Vietnamese
    • Has any stage colorectal, lung, or liver cancer
    • Has not started treatment or has not completed treatment
    • Is willing to stay in the study for six months.
  • FOR FULL IMPLEMENTATION:

    • Self-identifies as Asian American
    • Ages 21 or older
    • Lives in the 9 counties of the GBACR
    • Speaks English, Mandarin, Cantonese, or Vietnamese
    • Has any stage colorectal, lung, or liver cancer,
    • Has not started or has not completed treatment
    • Is willing to stay in the study for six-seven months

Exclusion Criteria:

*Any medical or psychological conditions precluding informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health services research (Patient COUNTS)
Patients attend focus groups to help develop patient portal and navigation program. Patients use in-person navigation program. Patients also complete data collection and surveys over 15 minutes via web portal at baseline, 3 months, and 6 months and user experience survey at end of program participation.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Use patient navigation program
Other Names:
  • Patient Navigator Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Participation
Time Frame: Any time between consent and month 6
At least one contact with patient navigator
Any time between consent and month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Guideline Treatment
Time Frame: Month 6
Positive response(s) to survey item(s) on completion of MD-recommended treatment
Month 6
Patient Acceptability
Time Frame: Month 7
Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program
Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tung T Nguyen, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2018

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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