Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

The University of Chicago

Status: Enrolling

Conditions: Malignant Neoplasm; Cancer; Malignancy

Treatments: Other: Digital Intervention; Other: Community Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT05886764

IRB23-0221

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Arm 1 (No Intervention)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Digital Intervention

Arm 3 (Digital Intervention + Community Outreach)

Experimental group

Description:

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.

Treatment:

Other: Community Outreach

Other: Digital Intervention