Cancer, Malignancy, Malignant Neoplasm
Conditions
Brief 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).
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.
Sponsors
University of Chicago
Stand Up To Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Patient participants will not be informed of which intervention they are assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients that enroll to early phase cancer treatment clinical trials. | within 2 months of randomization |
Secondary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWalter Stadler
University of Chicago
Outcome results
None listed