Bundled breast and colorectal screening plus genetic navigation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multisite randomized program enrolls women who are due for both breast and colorectal screening and who seek navigation at participating sites, then randomizes them to bundled multicancer (breast + colorectal) navigation or breast-only navigation with a wait-list control for colorectal navigation. The team will also compare usual-care genetics referral versus pretest education plus referral for those identified as eligible for genetic services in exploratory subgroups. Primary analyses focus on participants ineligible for genetics referral (target N=600) to test effectiveness for colorectal screening and non-inferiority for breast screening, while exploratory analyses (N≈180) examine four bundles combining navigation type with genetic counseling approaches. A mixed-methods, multisite process evaluation will examine how the bundles work at patient and organization levels across the Georgetown and ChristianaCare sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Seeking screening navigation services through programs at a participating site (Georgetown Lombardi Cancer Center or Helen F. Graham Cancer Center \& Research Institutes)
2. Eligible for breast cancer screening while also due and eligible for colorectal cancer screening (per USPSTF guidelines)
3. Female sex
4. Aged 45-74
5. Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity
6. Speak English or Spanish with enough fluency to complete study activities
7. Stated willingness to comply with all study procedures (navigation, surveys) and availability for the duration of the study
8. Provision of completed electronic informed consent form

Exclusion Criteria:

1. Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center \& Research Institute
2. Not eligible for breast cancer screening or not due and eligible for colorectal cancer screening (per USPSTF guidelines)
3. History of breast and/or colorectal cancer; or Reporting symptoms related to breast and/or colorectal cancer (e.g., GI bleeding, breast mass)
4. Male sex, Intersex, or other sex
5. Under age 45 or over age 74
6. Identifies as neither Black/African American race nor Hispanic/Latin(e)(a) ethnicity
7. Speaks neither English nor Spanish with enough fluency to complete study activities
8. Stated unwillingness to comply with study procedures (navigation, surveys) or unavailability for the duration of the study
9. Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf

Where it's running

• ChristianaCare-Helen F. Graham Cancer Center & Research Institute
  Newark, Delaware, United States Recruiting
• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Suzanne O'Neill, PhD
• Email: sco4@georgetown.edu
• Phone: 202-687-0869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.