Advancing Cancer Control Engaged Research Through Transformative Solutions (ACCERT) Social Determinants of Health (SDoH) Navigation Program (ACCERT SDoH)

June 22, 2026 updated by: Melissa Simon, Northwestern University

Advancing Cancer Control Engaged Research Through Transformative Solutions in Patient Navigation (ACCERT PN) Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on improving how patient navigators (PNs) help people get cancer care in Chicago. The goal is to reduce differences in cancer outcomes between communities by tackling common challenges like language barriers, difficulty understanding health information, and trouble accessing care.

The program is based on priorities identified by community partners, including:

  • Expanding patient navigation services so more people can use them
  • Making information easier to understand and available in different languages
  • Improving communication between patients and healthcare providers by sharing patient feedback

At the individual patient level, navigators will help people overcome obstacles (like scheduling, transportation, or understanding instructions). This support is expected to help patients complete important steps in their care, such as:

  • Getting screened for cancer
  • Following up on abnormal test results
  • Starting treatment on time

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard PN
Standard Patient Navigation (Standard-PN) A patient navigator will connect with you by phone and text messaging.
Other: Standard-PN
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.
Experimental: 4R PN
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

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.
Experimental: AI PN
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer screening utilization
Time Frame: From enrollment to the end of intervention at 12 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of SDOH barriers
Time Frame: From enrollment to the end of intervention at 12 months.
Patient Receipt of Resolution of Social Determinants of Health (SDoH) Barriers is an adjusted, composite proportion of items completed/resolved from those identified in the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool.
From enrollment to the end of intervention at 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Loyola University

Investigators

  • Principal Investigator: Melissa Simon, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00221529

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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