Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Trial Title: Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

NCT ID: NCT05886764

Condition: Cancer
Malignancy
Malignant Neoplasm

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: Single (Participant)

Masking description: Patient participants will not be informed of which intervention they are assigned.

Intervention:

Intervention type: Other
Intervention name: Digital Intervention
Description: Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Arm group label: Arm 2 (Digital Intervention)
Arm group label: Arm 3 (Digital Intervention + Community Outreach)

Intervention type: Other
Intervention name: Community Outreach
Description: Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
Arm group label: Arm 3 (Digital Intervention + Community Outreach)

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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Chicago Medicine Comprehensive Cancer Center

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Intake

Phone: 855-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu

Investigator:
Last name: Walter Stadler, MD
Email: Principal Investigator

Start date: October 23, 2023

Completion date: July 2027

Lead sponsor:
Agency: University of Chicago
Agency class: Other

Collaborator:
Agency: Stand Up To Cancer
Agency class: Other

Source: University of Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05886764