NCT07228000

Bundled Cancer Screening and Genetic Services Navigation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 820 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 45 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

Research Design and Methods: All women referred for screening navigation within community navigation programs receive familial cancer risk assessment, bundled with either multicancer (colorectal + breast) vs. single (breast) cancer navigation, with a wait list control for colorectal cancer screening referral and navigation, stratified by site and genetics referral eligibility. Primary analyses will be conducted among those randomized to multicancer or single cancer navigation, but ineligible for genetic referral, to test effectiveness for colorectal cancer screening and non-inferiority for breast cancer screening (N=600). In exploratory subanalyses among those referred to genetic counseling based on their familial cancer risk assessment, the study will test the effect of four bundles that combine multicancer vs. single cancer navigation with usual care referral to telephone-based pretest and posttest genetic counseling and testing or video and print pre-counseling education + referral (N=180). A multi-site, mixed-methods organization- and patient-focused process evaluation is conducted alongside and at the conclusion of the trial. Research Procedures: Research staff not associated with navigation programs will obtain consent and HIPAA authorization, proceeding with baseline assessment and randomization, stratified by site and genetics eligibility. The trial will recruit (N=820) and retain (N=780) women to this trial within two years. N=600 are retained for primary analyses; N=180 are retained for exploratory outcomes among those referred to genetic services. Randomization. At the end of the baseline assessment, research staff randomize participants to the single or multicancer navigation conditions, stratified by navigation site and genetic testing eligibility. Participants will be notified of study condition and connected to a navigator. Participants eligible for genetic services will receive services related to their study arm from their navigator following completion of multicancer or single cancer screening navigation. This will result in four bundles of screening and genetic services to be assessed in exploratory analyses. Contamination is mitigated through navigator training and supervision and documentation tracking. Participants will be randomized in blocks of 4 or 6 to support equal sample sizes across arms. Navigation Protocol. Guided stepwise protocols ensure documentation and timeliness of navigation and address contamination during navigation. Steps are chronological; navigators document completion of a step to move to the next. Wait-list navigation for those in the single cancer navigation arm who have not received colorectal cancer screening by 6-months will receive colorectal cancer screening referral and navigation at this time.

Conditions

• Breast Cancer Screening
• Colon Cancer Screening
• Genetics Predisposition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-02-28
• Completion: 2029-05-31
• First posted: 2025-11-13
• Last updated: 2026-03-09

Locations

2 sites across 1 country: United States