Actively Recruiting
Bundled Cancer Screening and Genetic Services Navigation for Breast and Colorectal Cancers
Led by Georgetown University · Updated on 2026-05-08
820
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how bundled familial cancer risk assessment combined with navigation for multiple cancers (colorectal and breast) compares to navigation for breast cancer alone. The study also examines usual care referral to genetic services versus pretest education plus usual care referral. Researchers will study how effective bundled multicancer navigation is and for whom it works best through a detailed patient- and organization-level process evaluation across multiple sites. Participants are women referred for screening navigation who will receive either multicancer navigation or single breast cancer navigation, with a wait list control for colorectal cancer screening referral. Those eligible for genetic services will be randomized to receive combinations of multicancer or single cancer navigation paired with either usual care genetic referral or pretest education plus usual care referral. Navigation involves education, barrier assessment, scheduling, reminders, and documentation of screening completion. Participants not screened for colorectal cancer after six months in the single navigation arm will receive delayed colorectal cancer screening navigation. Women in the study will complete baseline assessments and be randomized to one of the study arms. Researchers will monitor receipt of colorectal and breast cancer screenings six months after navigation completion. Assessments include documentation of navigation steps and participant follow-up. The study plans to recruit 820 women, retaining 780 for analysis over two years. A mixed-methods process evaluation will be conducted alongside the trial to understand the implementation and effectiveness of the interventions.
CONDITIONS
Brief Title
Bundled Cancer Screening and Genetic Services Navigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seeking screening navigation services through programs at a participating site
- Eligible for breast cancer screening and due for colorectal cancer screening per guidelines
- Female sex
- Aged between 45 and 74 years
- Identify as Black/African American race and/or Hispanic/Latina ethnicity
- Speak English or Spanish fluently enough to complete study activities
- Willing to comply with study procedures and available for the study duration
- Provide completed electronic informed consent form
You will not qualify if you...
- Not engaged with or planning to use navigation programs at participating sites
- Not eligible or due for breast or colorectal cancer screening per guidelines
- History of breast or colorectal cancer or having symptoms related to these cancers
- Male sex, intersex, or other sex
- Younger than 45 or older than 74 years
- Do not identify as Black/African American or Hispanic/Latina ethnicity
- Do not speak English or Spanish fluently enough to complete study activities
- Unwilling to comply with study procedures or unavailable for study duration
- Unable to provide electronic informed consent or needing another person to authorize consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive navigation services for breast cancer screening alone or combined breast and colorectal cancer screening. This includes education, barrier assessment, scheduling screenings, and reminders.
Multiple navigation calls and contacts over 6 months
Duration - Concurrent with navigation up to 6 months
Participants eligible for genetic services receive additional genetic counseling and referral services integrated with their screening navigation.
Genetic counseling and referrals provided during navigation contacts
Duration - After 6 months
Participants in the single cancer navigation arm who have not completed colorectal cancer screening by 6 months receive additional navigation and referral for colorectal cancer screening.
1 to 2 follow-up visits depending on screening status
Trial Site Locations
Total: 2 locations
1
ChristianaCare-Helen F. Graham Cancer Center & Research Institute
Newark, Delaware, United States, 19713
Actively Recruiting
2
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
S
Suzanne O'Neill, PhD
C
Chiranjeev Dash, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
6
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