Recruiting

Bundled Cancer Screening and Genetic Services Navigation

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…

ClinicalTrials.gov IDNCT07228000

PhaseNA

Enrollment820

SponsorGeorgetown University

Age45 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Screening, Colon Cancer Screening, Genetics Predisposition

About this study

Interventions

Behavioral: 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.
Behavioral: 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.
Behavioral: Usual care genetics referral — Referral for genetics will be provided at the completion of the navigation call.
Behavioral: 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 outcomes

Receipt of colorectal cancer screening (6 months after navigation completion)
Receipt of breast cancer screening (Six months after completion of navigation)

Eligibility information

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 locations

ChristianaCare-Helen F. Graham Cancer Center & Research Institute, Newark, Delaware 19713 United States
Georgetown University, Washington D.C., District of Columbia 20007 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.