Bundled Cancer Screening and Genetic Services Navigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-74
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Breast cancer screening navigation
BehavioralSingle 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
BehavioralMulti-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
BehavioralReferral for genetics will be provided at the completion of the navigation call.
Pretest education + usual care genetics referral
BehavioralPrint 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.
Treatment groups
820 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Usual care breast cancer screening navigationExperimental treatment 1 intervention
Group B: Multicancer screening navigationExperimental treatment 1 intervention
Group C: Usual care breast cancer screening navigation + usual care genetic referralExperimental treatment 2 interventions
Group D: Usual care breast cancer screening navigation + pretest education/usual care genetic referralExperimental treatment 2 interventions
Group E: Multicancer screening navigation + usual care genetic referralExperimental treatment 2 interventions
Group F: Multicancer screening navigation + pretest education/usual care genetic referralExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months after navigation completion2
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.
Time frame
Six months after completion of navigationOther outcomes
1
Receipt of genetic testing
Receipt of genetic testing as well as posttest genetic counseling within 6 months of randomization; documentation of test, test result, date, will be drawn from electronic health records
Time frame
Six months after completion of navigation2
Receipt of genetic counseling
Documented attendance/date of pretest genetic counseling appointment within 6 months of randomization
Time frame
Six months after completion of navigationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgetown University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov