CancerACCERT SDoHNCT07669753
Advancing Cancer Control Engaged Research Through Transformative Solutions (ACCERT) Social Determinants of Health (SDoH) Navigation Program
A study testing Standard-PN, 4R-PN and AI-PN in people with Cancer and Cancer , Healthy, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer , Healthy
- What is being tested?
- Standard-PN, 4R-PN and AI-PN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18
- Incarceration
- Adults unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Melissa Simon, (312) 503-8780, m-simon2@northwestern.edu
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer, Cancer , Healthy
- Being tested
- Standard-PN, 4R-PN, AI-PN
- Keywords
- cancer prevention, cancer screening
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-PNOther
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard PN | Active comparator | Standard Patient Navigation (Standard-PN) A patient navigator will connect with you by phone and text messaging. Receives: 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. Receives: 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. Receives: Other: AI-PN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 12 months.
Secondary outcomes (1)
Resolution of SDOH barriers
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.
Measured: From enrollment to the end of intervention at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University
- Responsible party
- Principal investigator, Melissa Simon, Northwestern University
- Investigators
- Melissa Simon, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669753
- Sponsor's protocol ID
- STU00221529
- Acronym
- ACCERT SDoH
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Cancer Control Engaged Research Through Transformative Solutions in Patient Navigation (ACCERT PN) Center
- ClinicalTrials.gov ID
- NCT07669753
- Acronym / sponsor ID
- ACCERT SDoH / STU00221529
- Conditions
- Cancer, Cancer , Healthy
- Keywords
- cancer prevention, cancer screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Loyola University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard PN | Active comparator | Other: Standard-PNStandard Patient Navigation (Standard-PN) A patient navigator will connect with you by phone and text messaging. |
| 4R PN | Experimental | Other: 4R-PN4R 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. |
| AI PN | Experimental | Other: AI-PNAI-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Age <18
- Incarceration
- Adults unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-PNThe 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. | Other | Standard PN |
| 4R-PNThe 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. | Other | 4R PN |
| AI-PNThe 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. | Other | AI PN |
Primary outcome
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.
1 secondary outcome
Resolution of SDOH barriers
Time frame: From enrollment to the end of intervention at 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Simon principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-PN, 4R-PN and AI-PN in people with Cancer and Cancer , Healthy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Simon ((312) 503-8780, m-simon2@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer screening utilization (time frame: From enrollment to the end of intervention at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.