Patient Navigation 2.0

NCT ID: NCT04234646

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2026-07-31

Brief Summary

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This study evaluates whether a "Patient Navigation 2.0 Checklist" intervention is effective in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

Detailed Description

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Cancer patient navigation (PN) is an effective strategy for resolving patient barriers to care and improving completion and consistency of cancer screening, follow-up of abnormal findings, and treatment initiation. However, as the current standard one-on-one PN model is challenging to scale across cancers and economically difficult to sustain, the investigators propose to convert one-on-one PN into a learning health system "PN 2.0 Checklist" that will help coordinate navigation workflow and integrate clinical team members with community/local resources. This pragmatic, randomized trial tests whether this checklist strategy is as effective as one-on-one PN in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

In this study, half of the participants will be navigated using the "PN 2.0 Checklist". The other half will be navigated using the "One-on-One PN". All participants enrolled in the study will be asked to report their utilization of health services and be asked to complete a patient survey at the beginning of the program and every 6 months.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1: One-on-One Patient Navigation

One-on-one Patient Navigation will be based on a Case Management Model where patients navigators perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources.

Group Type ACTIVE_COMPARATOR

One-on-one Patient Navigation (PN)

Intervention Type BEHAVIORAL

The one-on-one Patient Navigation will be based on a Case Management Model where PNs perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources

Group 2: Patient Navigation 2.0 Checklist

The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.

Group Type EXPERIMENTAL

Patient Navigation (PN) 2.0 Checklist

Intervention Type BEHAVIORAL

The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.

Interventions

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Patient Navigation (PN) 2.0 Checklist

The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.

Intervention Type BEHAVIORAL

One-on-one Patient Navigation (PN)

The one-on-one Patient Navigation will be based on a Case Management Model where PNs perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 21 or older
* Reside in one of the eight Chicago zip codes corresponding to Chinatown's geographical boundaries: 60605, 60607, 60608, 60609, 60616, 60623, 60632, 60653
* Self-identify as Chinese
* Not cognitively impaired
* Have the ability to participate in verbal survey in Cantonese, English, Mandarin, or Toishanese

Exclusion Criteria

* Cognitive impairment
* Incarceration
* Under 21 years of age
* Adult unable to consent
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern Illinois University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Melissa Simon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00211685

Identifier Type: -

Identifier Source: org_study_id