Bundled Cancer Screening and Genetic Services Navigation
NCT ID: NCT07228000
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
820 participants
INTERVENTIONAL
2026-05-01
2029-10-31
Brief Summary
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Detailed Description
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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 screning (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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Usual care breast cancer screening navigation
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.
Multicancer screening navigation
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.
Usual care breast cancer screening navigation + usual care genetic referral
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.
Usual care genetics referral
Referral for genetics will be provided at the completion of the navigation call.
Usual care breast cancer screening navigation + pretest education/usual care genetic referral
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.
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.
Multicancer screening navigation + usual care genetic referral
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.
Usual care genetics referral
Referral for genetics will be provided at the completion of the navigation call.
Multicancer screening navigation + pretest education/usual care genetic referral
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.
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.
Interventions
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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.
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.
Usual care genetics referral
Referral for genetics will be provided at the completion of the navigation call.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
74 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Georgetown University
OTHER
Responsible Party
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Locations
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ChristianaCare-Helen F. Graham Cancer Center & Research Institute
Newark, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Scott Siegel, PhD
Role: primary
Other Identifiers
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24-08-699
Identifier Type: -
Identifier Source: org_study_id