NCT04234646

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable cancer

Timeline
3mo left

Started Dec 2020

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Dec 2020Jul 2026

First Submitted

Initial submission to the registry

January 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

January 14, 2020

Last Update Submit

December 15, 2025

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers

    Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health (SDoH) Barriers is an adjusted, composite proportion of items completed/resolved in 2 domains: (1) USPSTF recommended cancer screenings, behavioral counseling, and immunizations; and (2) SDoH barriers resolved from those identified in the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool

    through study completion, an average of 18 months

Secondary Outcomes (2)

  • Timeliness of diagnostic resolution

    through study completion, an average of 18 months

  • Timeliness of treatment initiation

    through study completion, an average of 18 months

Study Arms (2)

Group 1: One-on-One Patient Navigation

ACTIVE COMPARATOR

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.

Behavioral: One-on-one Patient Navigation (PN)

Group 2: Patient Navigation 2.0 Checklist

EXPERIMENTAL

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.

Behavioral: Patient Navigation (PN) 2.0 Checklist

Interventions

Patient Navigation (PN) 2.0 ChecklistBEHAVIORAL

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 2: Patient Navigation 2.0 Checklist
One-on-one Patient Navigation (PN)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 1: One-on-One Patient Navigation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment
  • Incarceration
  • Under 21 years of age
  • Adult unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Melissa Simon, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 21, 2020

Study Start

December 9, 2020

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

US(1)