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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03867916
Other study ID # 184511
Secondary ID NCI-2018-02196
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2018
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date December 31, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Caregiver
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Malignant Neoplasm
  • Neoplasms
  • 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

Behavioral:
Patient Navigation Program
Use patient navigation program
Other:
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Bristol-Myers Squibb Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Participation At least one contact with patient navigator Any time between consent and month 6
Secondary Adherence to Guideline Treatment Positive response(s) to survey item(s) on completion of MD-recommended treatment Month 6
Secondary Patient Acceptability Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program Month 7
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