Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

NCT ID: NCT05886764

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Malignancy Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Patient participants will not be informed of which intervention they are assigned.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Digital Intervention

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Digital Intervention

Intervention Type OTHER

Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Community Outreach

Intervention Type OTHER

Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Intervention

Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Intervention Type OTHER

Community Outreach

Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* oncology provider at study site scheduled to see patients meeting criteria above

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stand Up To Cancer

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Walter Stadler

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Clinical Trials Intake

Role: primary

855-702-8222

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB23-0221

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Awareness Enhancing Interventions
NCT04683510 COMPLETED NA
CARE Tool Study Aim 3
NCT07296887 NOT_YET_RECRUITING NA
Randomized Trial of eOncoNote
NCT03333785 COMPLETED NA
Oncotool for Cancer Medications
NCT03952312 COMPLETED NA