Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University Of Chicago Medicine Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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. |
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|
Experimental: 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 messages (email, text, etc.) which include general educational information about clinical trials and available resources.
|
|
Experimental: 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 messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patients that enroll to early phase cancer treatment clinical trials.
Time Frame: within 2 months of randomization
|
within 2 months of randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of successfully completed outreach efforts
Time Frame: after 30 participants are enrolled to each of arms 2 and 3
|
after 30 participants are enrolled to each of arms 2 and 3
|
|
Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.
Time Frame: 2 years from randomization
|
2 years from randomization
|
|
Percent change in number of African Americans that enroll to cancer clinical trials
Time Frame: 2 years after study start
|
2 years after study start
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Briseis Aschebrook-Kilfoy, University Of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB23-0221
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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