Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

  • Interventional
  • Recruiting
  • NCT05886764
Eligibility Details Visit Clinicaltrials.gov

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT05886764

IRB#IRB23-0221

Lead SponsorUniversity of Chicago

Lead PhysicianWalter Stadler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting