Bundled breast and colorectal screening plus genetic navigation
Bundled Cancer Screening and Genetic Services Navigation
This program will test whether offering combined navigation for both breast and colorectal cancer screening, with genetic services when needed, helps Black and Hispanic women aged 45–74 complete recommended tests better than breast-only navigation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 820 (estimated) |
| Ages | 45 Years to 74 Years |
| Sex | Female |
| Sponsor | Georgetown University Academic / other |
| Locations | 2 sites (Newark, Delaware and 1 other locations) |
| Trial ID | NCT07228000 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 45–74 who identify as Black/African American and/or Hispanic/Latina, speak English or Spanish, are due for both breast and colorectal screening per USPSTF guidelines, and are seeking navigation services at the participating sites are ideal candidates.
Not a fit: People who are not due for breast or colorectal screening, are not using the participating navigation programs, are outside the 45–74 age range, are male, or have already completed relevant genetic testing are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the bundled approach could increase completion of both breast and colorectal screenings and streamline access to genetic services for eligible women in the targeted communities.
How similar studies have performed: Single-cancer navigation programs have previously improved screening uptake, but combining multicancer navigation with integrated genetic pretest education and referral is less tested and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Newark, Delaware and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.