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OpenTrials
Active, Not Recruiting

NCT Number: NCT05886764

Novel Outreach Methods to Increase Enrollment to Early Phase Clinical 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Intervention

Other

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

Community Outreach

Other

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

Primary outcomes

  1. Percentage of patients that enroll to early phase cancer treatment clinical trials.

    Time frame: within 2 months of randomization

Secondary outcomes

  1. Number of successfully completed outreach efforts

    Time frame: after 30 participants are enrolled to each of arms 2 and 3

  2. Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.

    Time frame: 2 years from randomization

  3. Percent change in number of African Americans that enroll to cancer clinical trials

    Time frame: 2 years after study start

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Stand Up To Cancer

Registry information

Official study title

Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jun 2, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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