NCT03867916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

March 6, 2019

Last Update Submit

January 10, 2023

Conditions

CaregiverMalignant NeoplasmPhysicianStage I Colorectal Cancer AJCC v8Stage I Liver CancerStage I Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Liver CancerStage II Lung Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Liver CancerStage III Lung Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Rate of Participation

    At least one contact with patient navigator

    Any time between consent and month 6

Secondary Outcomes (2)

  • Adherence to Guideline Treatment

    Month 6

  • Patient Acceptability

    Month 7

Study Arms (1)

Health services research (Patient COUNTS)

EXPERIMENTAL

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 ProgramOther: Quality-of-Life AssessmentOther: Survey Administration

Interventions

Patient Navigation ProgramBEHAVIORAL

Use patient navigation program

Also known as: Patient Navigator Program
Health services research (Patient COUNTS)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Health services research (Patient COUNTS)
Survey AdministrationOTHER

Ancillary studies

Health services research (Patient COUNTS)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • \*Any medical or psychological conditions precluding informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (2)

  • Wang K, Chu JN, Oh DL, Shariff-Marco S, Allen L, Kuo MC, Wong C, Bui H, Chen J, Li FM, Ma C, Truong A, Gomez SL, Nguyen TT, Tsoh JY. Correlates of supportive care needs among Asian Americans with colorectal, liver, or lung cancer from a web-based patient navigation portal intervention: The Patient COUNTS study. Cancer Rep (Hoboken). 2024 Feb;7(2):e1971. doi: 10.1002/cnr2.1971.

    PMID: 38351528DERIVED

  • 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.

    PMID: 36040670DERIVED

MeSH Terms

Conditions

NeoplasmsColorectal NeoplasmsLiver NeoplasmsLung Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Tung T Nguyen, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 8, 2019

Study Start

December 13, 2018

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)