Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

NCT05886764 | Active Not Recruiting

• 1 other identifier: IRB23-0221
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer; Malignancy; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percentage of patients that enroll to early phase cancer treatment clinical trials.

  within 2 months of randomization

Secondary Outcomes (3)

• Number of successfully completed outreach efforts

  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.

  2 years from randomization

• Percent change in number of African Americans that enroll to cancer clinical trials

  2 years after study start

Study Arms (3)

Arm 1 (No Intervention)

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.

Arm 2 (Digital Intervention)

EXPERIMENTAL

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

Arm 3 (Digital Intervention + Community Outreach)

EXPERIMENTAL

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; Other: Community Outreach

Interventions

Digital Intervention OTHER

Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Arm 2 (Digital Intervention); Arm 3 (Digital Intervention + Community Outreach)

Community Outreach OTHER

Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Arm 3 (Digital Intervention + Community Outreach)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Stand Up To Cancer: collaborator

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Community-Institutional Relations

Intervention Hierarchy (Ancestors)

Public Relations; Organization and Administration; Health Services Administration

Study Officials

• Briseis Aschebrook-Kilfoy

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient participants will not be informed of which intervention they are assigned.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: June 2, 2023
• Study Start: October 23, 2023
• Primary Completion: February 26, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)