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

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03867916
Collaborator
Bristol-Myers Squibb Foundation (Other)
106
Enrollment
1
Location
1
Arm
48.6
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Navigation Program
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

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

  2. 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.

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer
Actual Study Start Date :
Dec 13, 2018
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Behavioral: Patient Navigation Program
Use patient navigation program
Other Names:
  • Patient Navigator Program

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Participation [Any time between consent and month 6]

      At least one contact with patient navigator

    Secondary Outcome Measures

    1. Adherence to Guideline Treatment [Month 6]

      Positive response(s) to survey item(s) on completion of MD-recommended treatment

    2. Patient Acceptability [Month 7]

      Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94158

    Sponsors and Collaborators

    • University of California, San Francisco
    • Bristol-Myers Squibb Foundation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03867916
    Other Study ID Numbers:
    • 184511
    • NCI-2018-02196
    First Posted:
    Mar 8, 2019
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lung Neoplasms
    Colorectal Neoplasms
    Liver Neoplasms
    Neoplasms

    Study Results

    No Results Posted as of Jun 21, 2022