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Completed

NCT Number: NCT04234646

Patient Navigation 2.0

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation (PN) 2.0 Checklist

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.

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

Primary outcomes

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

    Time frame: through study completion, an average of 18 months

    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

Secondary outcomes

  1. Timeliness of diagnostic resolution

    Time frame: through study completion, an average of 18 months

    Time from an abnormal screening result to diagnostic resolution

  2. Timeliness of treatment initiation

    Time frame: through study completion, an average of 18 months

    Time from diagnostic resolution to initiation of treatment

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Northeastern Illinois University

Registry information

Official study title

Patient Navigation 2.0: Addressing the Challenge of Scaling Navigation Through Checklist-based Implementation

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2020
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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