- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867916
Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients
The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer
Study Overview
Status
Conditions
- Stage III Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Malignant Neoplasm
- Stage III Colorectal Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- 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 IIIC Lung Cancer AJCC v8
- Stage I Colorectal Cancer AJCC v8
- Stage II Colorectal Cancer AJCC v8
- Stage IIA Colorectal Cancer AJCC v8
- Stage IIB Colorectal Cancer AJCC v8
- Stage IIC Colorectal Cancer AJCC v8
- Caregiver
- Stage III Liver Cancer
- Physician
- Stage I Liver Cancer
- Stage II Liver Cancer
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
Ancillary studies
Use patient navigation program
Other Names:
|
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
Collaborators
Investigators
- Principal Investigator: Tung T Nguyen, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
- Liver Neoplasms
Other Study ID Numbers
- 184511
- NCI-2018-02196 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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