Recruiting

Bundled Navigation vs. Single Navigation

Sponsor:

Georgetown University

Code:

NCT07228000

Conditions

Breast Cancer Screening

Colon Cancer Screening

Genetics Predisposition

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Breast cancer screening navigation

Multicancer screening navigation

Usual care genetics referral

Pretest education + usual care genetics referral

Study Details

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.

Conditions

Breast Cancer Screening

Colon Cancer Screening

Genetics Predisposition

Study ID

NCT07228000

Start date

May 6, 2026

Status verified date

May, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

820 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Usual care breast cancer screening navigation

experimental: Multicancer screening navigation

experimental: Usual care breast cancer screening navigation + usual care genetic referral

experimental: Usual care breast cancer screening navigation + pretest education/usual care genetic referral

experimental: Multicancer screening navigation + usual care genetic referral

experimental: Multicancer screening navigation + pretest education/usual care genetic referral

Interventions

Breast cancer screening navigation

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.

Multicancer screening navigation

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.

Usual care genetics referral

Referral for genetics will be provided at the completion of the navigation call.

Pretest education + usual care genetics referral

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.

Primary outcome measure

  • Receipt of colorectal cancer screening [ Time Frame: 6 months after navigation completion ]
  • Receipt of breast cancer screening [ Time Frame: Six months after completion of navigation ]

Central Contacts and Locations

Central contacts

Suzanne O'Neill, PhD

202-687-0869sco4@georgetown.edu

Chiranjeev Dash, PhD

202-687-1542cd422@georgetown.edu

Locations

ChristianaCare-Helen F. Graham Cancer Center & Research Institute

Recruiting

Newark, Delaware, United States, 19713

Contacts

Scott Siegel, PhD

SSiegel@christianacare.org

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Suzanne O'Neill, PhD

202-687-0869sco4@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • navigation
  • mammography
  • colonoscopy
  • Fecal Immunochemical Test
  • genetic testing
  • risk assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-05-08.