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

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ClinicalTrials.gov Identifier: NCT03867916
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 203 participants
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
  • FOR INTERVIEWS AND FOCUS GROUPS: Caregivers: any person who has provided care to an Asian American cancer patient
  • FOR INTERVIEWS AND FOCUS GROUPS: Health professionals: physicians and other health professionals who provide care to Asian American patients with cancer
  • FOR PILOT AND FULL IMPLEMENTATION: Self-identifies as Asian American, lives in San Francisco, speaks English, Mandarin, Cantonese, or Vietnamese, has stage I-III colorectal, lung, or liver cancer, has not yet undergone treatment
  • FOR PILOT AND FULL IMPLEMENTATION: Is willing to stay in the study for six months

Exclusion Criteria:

  • Any medical or psychological conditions precluding informed consent
Contacts and Locations
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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
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Contact: Laura Allen 415-514-3423 Laura.Allen@ucsf.edu

Locations
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United States, California
UCSF Medical Center-Mount Zion Not yet recruiting
San Francisco, California, United States, 94115
Contact: Tung T. Nguyen    415-514-8659      
Principal Investigator: Tung T. Nguyen         
UCSF Medical Center-Mission Bay Not yet recruiting
San Francisco, California, United States, 94158
Contact: Tung T. Nguyen    415-514-8659      
Principal Investigator: Tung T. Nguyen         
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tung T Nguyen UCSF Medical Center-Mount Zion
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03867916     History of Changes
Other Study ID Numbers: 184511
NCI-2018-02196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA082103 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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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:
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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