RecruitingNot ApplicableNCT05886764

Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials


Sponsor

University of Chicago

Enrollment

180 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria5

  • 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

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Interventions

OTHERDigital Intervention

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

OTHERCommunity Outreach

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


Locations(1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

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NCT05886764


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