CaregiverNCT03867916

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

A study testing Patient Navigation Program, Quality-of-Life Assessment and Survey Administration in people with Caregiver and Malignant Neoplasm, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Caregiver, Malignant Neoplasm, Physician
What is being tested?: Patient Navigation Program, Quality-of-Life Assessment and Survey Administration
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 13 Dec 2018to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

Any medical or psychological conditions precluding informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94158

Other trials in United States

About this study

Official title: The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Caregiver, Malignant Neoplasm, Physician, Stage I Colorectal Cancer AJCC v8, Stage I Liver Cancer, Stage I Lung Cancer AJCC v8
Being tested: Patient Navigation Program, Quality-of-Life Assessment, Survey Administration
Medical subject headings: Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient Navigation ProgramBehavioural
Also called Patient Navigator Program
Use patient navigation program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies

Study groups in NCT03867916
Study group	Role	What they receive
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. Receives: Behavioral: Patient Navigation Program; Other: Quality-of-Life Assessment; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Participation
At least one contact with patient navigator
Measured: Any time between consent and month 6

Secondary outcomes (2)

Adherence to Guideline Treatment
Positive response(s) to survey item(s) on completion of MD-recommended treatment
Measured: Month 6
Patient Acceptability
Response of "satisfied" or "very satisfied" to survey item on satisfaction with Patient COUNTS navigation program
Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201831 Dec 2022

First posted8 Mar 2019
Study start13 Dec 2018
Primary completion30 Nov 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CaregiverStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03867916
Sponsor's protocol ID: 184511
Other IDs: NCI-2018-02196
Status last verified: Jan 2023
First submitted: 6 Mar 2019
Last updated: 12 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38351528
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.
PubMed 36040670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Patient Cancer OUtreach, Navigation, Technology, and Support (Patient COUNTS) Project: Addressing Care for Asian Americans With Cancer
ClinicalTrials.gov ID: NCT03867916
Acronym / sponsor ID: 184511
Conditions: Caregiver, Malignant Neoplasm, Physician, Stage I Colorectal Cancer AJCC v8, Stage I Liver Cancer, Stage I Lung Cancer AJCC v8
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: 13 Dec 2018 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 8 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Identify Asian American adults newly diagnosed with colorectal, liver, or lung cancer using a population-based cancer registry.

III. Provide patient navigation either virtually or in-person.

OUTLINE:

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Health services research (Patient COUNTS)	Experimental	Behavioral: Patient Navigation Program, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

FOR INTERVIEWS AND FOCUS GROUPS:
FOR PILOT IMPLEMENTATION:
FOR FULL IMPLEMENTATION:

Key exclusion criteria (1 listed)

Any medical or psychological conditions precluding informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient Navigation ProgramAlso: Patient Navigator ProgramUse patient navigation program	Behavioural	Health services research (Patient COUNTS)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Health services research (Patient COUNTS)
Survey AdministrationAncillary studies	Other	Health services research (Patient COUNTS)

Primary outcome

Rate of Participation
Time frame: Any time between consent and month 6
At least one contact with patient navigator

2 secondary outcomes

Adherence to Guideline Treatment
Time frame: Month 6
Patient Acceptability
Time frame: Month 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Derived from this study: PubMed 38351528Wang 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.
Derived from this study: PubMed 36040670Wang 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tung T Nguyen, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Participation (time frame: Any time between consent and month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867916, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.