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Bundled Cancer Screening and Genetic Services Navigation

NCT07228000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2029-02-28
Completion
2029-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07228000 on ClinicalTrials.gov