NCT07228000 · Georgetown University
Bundled Cancer Screening and Genetic Services Navigation
What this study is about
The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation. Among those eligible, this study will test usual care referral to genetic services vs. pretest education + usual care referral.
View original scientific description
The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation. Among those eligible, this study will test usual care referral to genetic services vs. pretest education + usual care referral. The study also will assess how bundled multicancer navigation works and for whom it is most effective through a multisite, mixed-methods patient- and organization-level process evaluation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Seeking screening navigation services through programs at a participating site (Georgetown Lombardi Cancer Center or Helen F. Graham Cancer Center \& Research Institutes)
- Eligible for breast cancer screening while also due and eligible for colorectal cancer screening (per USPSTF guidelines)
- Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity
- Speak English or Spanish with enough fluency to complete study activities
- Stated willingness to comply with all study procedures (navigation, surveys) and availability for the duration of the study
- Provision of completed electronic informed consent form
Exclusion criteria
- Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center \& Research Institute
- Not eligible for breast cancer screening or not due and eligible for colorectal cancer screening (per USPSTF guidelines)
- History of breast and/or colorectal cancer; or Reporting symptoms related to breast and/or colorectal cancer (e.g., GI bleeding, breast mass)
- Male sex, Intersex, or other sex
- Under age 45 or over age 74
- Identifies as neither Black/African American race nor Hispanic/Latin(e)(a) ethnicity
- Speaks neither English nor Spanish with enough fluency to complete study activities
- Stated unwillingness to comply with study procedures (navigation, surveys) or unavailability for the duration of the study
- Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf
Where
- Newark, Delaware
- Washington D.C., District of Columbia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations