Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

April 22, 2026 updated by: University of Chicago

Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials

This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

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 Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine Comprehensive Cancer Center

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

No

Description

Inclusion Criteria for Patient Subjects:

  • Aged 18 years or older
  • Self-described African American race (patients who self-describe as "more than one race" will be included)
  • Scheduled for new or consult oncology appointment at the study site

  • Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.

    • for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
  • other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site

Inclusion Criteria for Provider Subjects:

  • oncology provider at study site scheduled to see patients meeting criteria above

Exclusion Criteria for Patient Subjects:

  • Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
  • Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
  • Initiated new anti-cancer therapy within last 2 months
  • Evaluated for possible enrollment/randomization in the last 2 months
  • Prior enrollment/randomization on this recruitment trial

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 1 (No Intervention)

Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods.

Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
Experimental: Arm 2 (Digital Intervention)

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
Other: Digital Intervention
Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Experimental: Arm 3 (Digital Intervention + Community Outreach)

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
Other: Digital Intervention
Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Other: Community Outreach
Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients that enroll to early phase cancer treatment clinical trials.
Time Frame: within 2 months of randomization
within 2 months of randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of successfully completed outreach efforts
Time Frame: after 30 participants are enrolled to each of arms 2 and 3
after 30 participants are enrolled to each of arms 2 and 3
Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.
Time Frame: 2 years from randomization
2 years from randomization
Percent change in number of African Americans that enroll to cancer clinical trials
Time Frame: 2 years after study start
2 years after study start

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

Stand Up To Cancer

Investigators

  • Principal Investigator: Briseis Aschebrook-Kilfoy, University of Chicago

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)

October 23, 2023

Primary Completion (Actual)

February 26, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0221

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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