RecruitingNot ApplicableNCT07228000

Bundled Cancer Screening and Genetic Services Navigation


Sponsor

Georgetown University

Enrollment

820 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Inclusion Criteria8

  • 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

Exclusion Criteria9

  • 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

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Interventions

BEHAVIORALBreast 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.

BEHAVIORALMulticancer 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.

BEHAVIORALUsual care genetics referral

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

BEHAVIORALPretest 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.


Locations(2)

ChristianaCare-Helen F. Graham Cancer Center & Research Institute

Newark, Delaware, United States

Georgetown University

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

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NCT07228000


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