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

Primary Purpose

Caregiver, Malignant Neoplasm, Physician

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation Program
Quality-of-Life Assessment
Survey Administration
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Caregiver

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (Patient COUNTS)

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Participation
At least one contact with patient navigator

Secondary Outcome Measures

Adherence to Guideline Treatment
Positive response(s) to survey item(s) on completion of MD-recommended treatment
Patient Acceptability
Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program

Full Information

First Posted
March 6, 2019
Last Updated
January 10, 2023
Sponsor
University of California, San Francisco
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03867916
Brief Title
Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients
Official Title
The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Bristol-Myers Squibb

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health services research (Patient COUNTS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation Program
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Use patient navigation program
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Rate of Participation
Description
At least one contact with patient navigator
Time Frame
Any time between consent and month 6
Secondary Outcome Measure Information:
Title
Adherence to Guideline Treatment
Description
Positive response(s) to survey item(s) on completion of MD-recommended treatment
Time Frame
Month 6
Title
Patient Acceptability
Description
Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program
Time Frame
Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung T Nguyen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36040670
Citation
Wang K, Ma C, Li FM, Truong A, Shariff-Marco S, Chu JN, Oh DL, Allen L, Kuo MC, Wong C, Bui H, Chen J, Gomez SL, Nguyen TT, Tsoh JY. Patient-reported supportive care needs among Asian American cancer patients. Support Care Cancer. 2022 Nov;30(11):9163-9170. doi: 10.1007/s00520-022-07338-2. Epub 2022 Aug 30.
Results Reference
derived

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

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