Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
NCT ID: NCT05886764
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-10-23
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Arm 1 (No Intervention)
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.
No interventions assigned to this group
Arm 2 (Digital Intervention)
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.
Digital Intervention
Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Arm 3 (Digital Intervention + Community Outreach)
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Stand Up To Cancer
OTHER
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Walter Stadler
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Facility Contacts
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Other Identifiers
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IRB23-0221
Identifier Type: -
Identifier Source: org_study_id
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