Bundled Cancer Screening and Genetic Services Navigation
2 other identifiers
interventional
820
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2025
CompletedFirst Posted
Study publicly available on registry
November 13, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
March 9, 2026
March 1, 2026
2.8 years
November 12, 2025
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Receipt of colorectal cancer screening
Colorectal cancer screening will be determined through electronic health records abstraction. Documentation of screening includes the test (FIT, colonoscopy), date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
6 months after navigation completion
Receipt of breast cancer screening
Breast cancer screening (mammography, tomosynthesis, MRI, breast ultrasound, breast biopsy) will be determined through electronic health records abstraction. Documentation of screening includes the test, date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
Six months after completion of navigation
Other Outcomes (2)
Receipt of genetic testing
Six months after completion of navigation
Receipt of genetic counseling
Six months after completion of navigation
Study Arms (6)
Usual care breast cancer screening navigation
EXPERIMENTALMulticancer screening navigation
EXPERIMENTALUsual care breast cancer screening navigation + usual care genetic referral
EXPERIMENTALUsual care breast cancer screening navigation + pretest education/usual care genetic referral
EXPERIMENTALMulticancer screening navigation + usual care genetic referral
EXPERIMENTALMulticancer screening navigation + pretest education/usual care genetic referral
EXPERIMENTALInterventions
Single cancer navigation includes the following, oriented to breast cancer only: cancer education, barrier assessment and resolution, screening exam scheduling, text and mail reminders, documentation of appointment completion and results communicated to patient.
Multi-cancer navigation includes the following, oriented to breast and colorectal cancers: cancer education, barrier assessment and resolution, screening exam scheduling, text and mail reminders, documentation of appointment completion and results communicated to patient.
Referral for genetics will be provided at the completion of the navigation call.
Print education regarding the genetic counseling and testing process and specific tips to support at-home testing. Referral for genetics will be provided at the completion of the navigation call.
Eligibility Criteria
You may qualify if:
- 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)
- Female sex
- Aged 45-74
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
ChristianaCare-Helen F. Graham Cancer Center & Research Institute
Newark, Delaware, 19713, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2025
First Posted
November 13, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
March 9, 2026
Record last verified: 2026-03