Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Not Applicable

Recruiting

• Conditions: Cancer; Malignant Neoplasm; Malignancy
• Interventions: Other: Digital Intervention; Other: Community Outreach

• Registration Number: NCT05886764
• Lead Sponsor: University of Chicago

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Study Start: 2023-10-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3 (Digital Intervention + Community Outreach)	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.
Arm 2 (Digital Intervention)	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.
Arm 3 (Digital Intervention + Community Outreach)	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. 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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients that enroll to early phase cancer treatment clinical trials.	within 2 months of randomization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States