NCT07669753

Brief Summary

The purpose of this study is to evaluate patient navigation programs designed to reduce barriers to cancer screening and improve healthcare experiences for adults living in Chicago. Participants will be asked to complete two surveys: the first survey shortly after the participants join the study and a second survey after 1 year. Participants will be joining one of three patient navigation programs, assigned at random. The investigators expect the participants to be in this patient navigation program for 12 months, followed by a 1-month window to complete the final survey.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable cancer

Timeline
38mo left

Started Jun 2026

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress5%
Jun 2026Aug 2029

Study Start

First participant enrolled

June 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 15, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

cancer preventioncancer screening

Outcome Measures

Primary Outcomes (1)

  • Cancer screening utilization

    Patient Receipt of Clinical Cancer Preventive Services composite proportion of items completed/resolved in NCCN and USPSTF recommended cancer screenings, behavioral counseling, and immunizations.

    From enrollment to the end of intervention at 12 months.

Secondary Outcomes (1)

  • Resolution of SDOH barriers

    From enrollment to the end of intervention at 12 months.

Study Arms (3)

Standard PN

ACTIVE COMPARATOR

Standard Patient Navigation (Standard-PN) A patient navigator will connect with you by phone and text messaging.

Other: Standard-PN

4R PN

EXPERIMENTAL

4R Checklist Patient Navigation (4R-PN) A patient navigator will connect with you by phone and text messaging plus a "Get Healthy" checklist tool will be available for you.

Other: 4R-PN

AI PN

EXPERIMENTAL

AI-Augmented Patient Navigation (AI-PN) A patient navigator will connect with you by phone and text messaging plus an AI chatbot will be available for you to use on your phone or personal device.

Other: AI-PN

Interventions

The standard health navigation group will work with a Health Navigator during the 12 months time in the study. A Health Navigator is a trained, non-clinical staff member who helps the participants understand and access cancer screening and follow-up care. They are not doctors or nurses, but they work to support the participants in navigating the healthcare system.

Standard PN
4R-PNOTHER

The standard Health Navigation with the "Get Healthy" checklist group will work with a Health Navigator and a guided checklist over the next 12 months. A Health Navigator is a trained, non-clinical staff member who helps you understand and access cancer screening and follow-up care. They are not doctors or nurses, but they work to support you in navigating the healthcare system.

4R PN
AI-PNOTHER

The health navigation with the AI chatbot group will work with a Health Navigator and an AI Chatbot over 12 months. A Health Navigator is a trained, non-clinical staff member who helps you understand and access cancer screening and follow-up care. They are not doctors or nurses, but they work to support you in navigating the healthcare system.

AI PN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18 years and older;
  • able to complete verbal survey in English, Spanish, or Mandarin/Cantonese Chinese;
  • reside in Chicago;
  • able to give informed consent;
  • agree to a verbal consent document prior to being registered in the study;
  • has a smart device with access to the internet.

You may not qualify if:

  • Age \<18
  • Incarceration
  • Adults unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Melissa Simon

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 25, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations