Bundled Cancer Screening and Genetic Services Navigation
Recruiting · NCT07228000 · Interventional (participants receive a specific treatment) · Lead sponsor: Georgetown University
View the official record on ClinicalTrials.gov →Interventions studied
Breast cancer screening navigationMulticancer screening navigationPretest education + usual care genetics referralUsual care genetics referral
What this trial is about
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.
Who can take part
Age range
45 Years to 74 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where it is running
2 locations listed across 2 US states.
- ChristianaCare-Helen F. Graham Cancer Center & Research Institute - Newark, Delaware, United States
- Georgetown University - Washington D.C., District of Columbia, United States