Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Cancer Clinical Trial

Official title:

Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886764
• Other study ID #: IRB23-0221
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Malignancy
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Digital Intervention
Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
• Community Outreach
Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Locations

Country	Name	City	State
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Stand Up To Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that enroll to early phase cancer treatment clinical trials.		within 2 months of randomization
Secondary	Number of successfully completed outreach efforts		after 30 participants are enrolled to each of arms 2 and 3
Secondary	Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.		2 years from randomization
Secondary	Percent change in number of African Americans that enroll to cancer clinical trials		2 years after study start