Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867916
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Caregiver Malignant Neoplasm Physician Stage I Colorectal Cancer AJCC v8 Stage I Liver Cancer Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage II Liver Cancer Stage II Lung Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Colorectal Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage IIC Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Liver Cancer Stage III Lung Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Behavioral: Patient Navigation Program Other: Quality-of-Life Assessment Other: Survey Administration Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 203 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 : July 31, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Patient Navigator Program

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Ancillary studies


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rate of Participation [ Time Frame: Any time between consent and month 6 ]
    At least one contact with patient navigator


Secondary Outcome Measures :
  1. Adherence to Guideline Treatment [ Time Frame: Month 6 ]
    Positive response(s) to survey item(s) on completion of MD-recommended treatment

  2. Patient Acceptability [ Time Frame: Month 7 ]
    Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 AND FULL 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 stage I-III 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 stage I-III 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867916


Contacts
Layout table for location contacts
Contact: Laura Allen 415-514-3423 Laura.Allen@ucsf.edu
Contact: Tung T Nguyen, MD 415-514-8659 cancertrials@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Tung T. Nguyen, MD    415-514-8659    cancertrials@ucsf.edu   
Principal Investigator: Tung T. Nguyen, MD         
Sponsors and Collaborators
University of California, San Francisco
Bristol-Myers Squibb Foundation
Investigators
Layout table for investigator information
Principal Investigator: Tung T Nguyen, MD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03867916    
Other Study ID Numbers: 184511
NCI-2018-02196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Lung Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases