Bundled Cancer Screening and Genetic Services Navigation

Part of paid clinical trials in Newark, Delaware.

Sponsor
Georgetown University
Study ID
NCT07228000
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Screening
  • Colon Cancer Screening
  • Genetics Predisposition

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 74 Years
Healthy Volunteers
Accepted

Interventions

  • Breast cancer screening navigation — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Referral for genetics will be provided at the completion of the navigation call.
  • Pretest education + usual care genetics referral — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
May 31, 2029

Study Design

Enrollment
820 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
ChristianaCare-Helen F. Graham Cancer Center & Research InstituteNewarkDelaware19713
Scott Siegel, PhD
[email protected]
Georgetown UniversityWashington D.C.District of Columbia20007
Suzanne O'Neill, PhD
[email protected]
202-687-0869

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By research site
ChristianaCare-Helen F. Graham Cancer Center & Research Institute· Newark, DEGeorgetown University· Washington D.C., DC

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