Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials

Conditions
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Cancer, Malignancy, Malignant Neoplasm

Intervention / Treatment
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* Other: Digital Intervention
* Other: Community Outreach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1 (No Intervention)<br>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. | |
| Experimental: Arm 2 (Digital Intervention)<br>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. | Other: Digital Intervention<br>* Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.<br>|
| Experimental: Arm 3 (Digital Intervention + Community Outreach)<br>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. | Other: Digital Intervention<br>* Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.<br>Other: Community Outreach<br>* Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that enroll to early phase cancer treatment clinical trials. |  | within 2 months of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successfully completed outreach efforts |  | 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. |  | 2 years from randomization | 
| Percent change in number of African Americans that enroll to cancer clinical trials |  | 2 years after study start |