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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

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 8, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
Rate of participation [ Time Frame: Any time between consent and month 6 ]
At least one contact with patient navigator
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients
Official Title  ICMJE The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Behavioral: Patient Navigation Program
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2019)
203
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Laura Allen 415-514-3423 Laura.Allen@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867916
Other Study ID Numbers  ICMJE 184511
NCI-2018-02196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA082103 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Tung T Nguyen UCSF Medical Center-Mount Zion
PRS Account University of California, San Francisco
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP