Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients
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ClinicalTrials.gov Identifier: NCT03867916 |
Recruitment Status :
Recruiting
First Posted : March 8, 2019
Last Update Posted : June 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

Arm | Intervention/treatment |
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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.
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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 |
- Rate of Participation [ Time Frame: Any time between consent and month 6 ]At least one contact with patient navigator
- Adherence to Guideline Treatment [ Time Frame: Month 6 ]Positive response(s) to survey item(s) on completion of MD-recommended treatment
- Patient Acceptability [ Time Frame: Month 7 ]Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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
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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.
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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

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
Contact: Laura Allen | 415-514-3423 | Laura.Allen@ucsf.edu | |
Contact: Tung T Nguyen, MD | 415-514-8659 | cancertrials@ucsf.edu |
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 |
Principal Investigator: | Tung T Nguyen, MD | University of California, San Francisco |
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 |
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 |
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 |