Breast Cancer ScreeningNCT07228000
Bundled Cancer Screening and Genetic Services Navigation
A study testing Breast cancer screening navigation and Multicancer screening navigation in people with Breast Cancer Screening and Colon Cancer Screening, run by Georgetown University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening, Colon Cancer Screening, Genetics Predisposition
- What is being tested?
- Breast cancer screening navigation and Multicancer screening navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2026to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
ChristianaCare-Helen F. Graham Cancer Center & Research Institute
Newark, Delaware, 19713
Scott Siegel, PhD, SSiegel@christianacare.org
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Suzanne O'Neill, PhD, 202-687-0869, sco4@georgetown.edu
About this study
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.
Read the 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.
- Being tested
- Breast cancer screening navigation, Multicancer screening navigation, Usual care genetics referral, Pretest education + usual care genetics referral
- Keywords
- navigation, mammography, colonoscopy, Fecal Immunochemical Test, genetic testing, risk assessment
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer screening navigationBehavioural
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 navigationBehavioural
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 referralBehavioural
Referral for genetics will be provided at the completion of the navigation call.
Pretest education + usual care genetics referralBehavioural
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 group | Role | What they receive |
|---|---|---|
| Usual care breast cancer screening navigation | Experimental | Not described Receives: Behavioral: Breast cancer screening navigation |
| Multicancer screening navigation | Experimental | Not described Receives: Behavioral: Multicancer screening navigation |
| Usual care breast cancer screening navigation + usual care genetic referral | Experimental | Not described Receives: Behavioral: Breast cancer screening navigation; Behavioral: Usual care genetics referral |
| Usual care breast cancer screening navigation + pretest education/usual care genetic referral | Experimental | Not described Receives: Behavioral: Breast cancer screening navigation; Behavioral: Pretest education + usual care genetics referral |
| Multicancer screening navigation + usual care genetic referral | Experimental | Not described Receives: Behavioral: Multicancer screening navigation; Behavioral: Usual care genetics referral |
| Multicancer screening navigation + pretest education/usual care genetic referral | Experimental | Not described Receives: Behavioral: Multicancer screening navigation; Behavioral: Pretest education + usual care genetics referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of colorectal cancer screening
Colorectal cancer screening will be determined through electronic health records abstraction. Documentation of screening includes the test (FIT, colonoscopy), date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
Measured: 6 months after navigation completion
Receipt of breast cancer screening
Breast cancer screening (mammography, tomosynthesis, MRI, breast ultrasound, breast biopsy) will be determined through electronic health records abstraction. Documentation of screening includes the test, date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
Measured: Six months after completion of navigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start6 May 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228000
- Sponsor's protocol ID
- 24-08-699
- Other IDs
- R01CA301168
- Status last verified
- May 2026
- First submitted
- 12 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bundled Cancer Screening and Genetic Services Navigation
- ClinicalTrials.gov ID
- NCT07228000
- Acronym / sponsor ID
- 24-08-699
- Keywords
- navigation, mammography, colonoscopy, Fecal Immunochemical Test, genetic testing, risk assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Usual care breast cancer screening navigation | Experimental | Behavioral: Breast cancer screening navigation |
| Multicancer screening navigation | Experimental | Behavioral: Multicancer screening navigation |
| Usual care breast cancer screening navigation + usual care genetic referral | Experimental | Behavioral: Breast cancer screening navigation, Behavioral: Usual care genetics referral |
| Usual care breast cancer screening navigation + pretest education/usual care genetic referral | Experimental | Behavioral: Breast cancer screening navigation, Behavioral: Pretest education + usual care genetics referral |
| Multicancer screening navigation + usual care genetic referral | Experimental | Behavioral: Multicancer screening navigation, Behavioral: Usual care genetics referral |
| Multicancer screening navigation + pretest education/usual care genetic referral | Experimental | Behavioral: Multicancer screening navigation, Behavioral: Pretest education + usual care genetics referral |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancer screening navigationSingle 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. | Behavioural | Usual care breast cancer screening navigation, Usual care breast cancer screening navigation + pretest education/usual care genetic referral, Usual care breast cancer screening navigation + usual care genetic referral |
| Multicancer screening navigationMulti-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. | Behavioural | Multicancer screening navigation, Multicancer screening navigation + pretest education/usual care genetic referral, Multicancer screening navigation + usual care genetic referral |
| Usual care genetics referralReferral for genetics will be provided at the completion of the navigation call. | Behavioural | Multicancer screening navigation + usual care genetic referral, Usual care breast cancer screening navigation + usual care genetic referral |
| Pretest education + usual care genetics referralPrint 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. | Behavioural | Multicancer screening navigation + pretest education/usual care genetic referral, Usual care breast cancer screening navigation + pretest education/usual care genetic referral |
Primary outcome
Receipt of colorectal cancer screening
Time frame: 6 months after navigation completion
Colorectal cancer screening will be determined through electronic health records abstraction. Documentation of screening includes the test (FIT, colonoscopy), date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
Receipt of breast cancer screening
Time frame: Six months after completion of navigation
Breast cancer screening (mammography, tomosynthesis, MRI, breast ultrasound, breast biopsy) will be determined through electronic health records abstraction. Documentation of screening includes the test, date, clinical indication, assessment or result (imaging, pathology) and recommendations and procedures as applicable, following to treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Related trials for Breast Cancer Screening
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
RecruitingObservational study
National Mammography Database
Breast Cancer Screening and Diagnosis
Active, not recruiting
MADRE (Mammograms Available Due to Research and Education)
Breast Cancer Screening
Not yet recruiting
Screening and the Future of Enhanced MRI for Early Breast Cancer Detection
Breast Cancer Detection, Breast Cancer
Not yet recruiting
Cancer Awareness Among Syrian Migrants
Breast Cancer Screening, Cervical Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast cancer screening navigation and Multicancer screening navigation in people with Breast Cancer Screening and Colon Cancer Screening, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne O'Neill, PhD (202-687-0869, sco4@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of colorectal cancer screening (time frame: 6 months after navigation completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.