An official website of the United States government
Testing Different Approaches to Cancer Screening and Genetic Services Navigation to Improve Breast and Colorectal Cancer Screening among Black/African American and Hispanic Women
Trial Status: active
This clinical trial tests different approaches to cancer screening and genetic services navigation to improve breast and colorectal cancer screening among Black/African American and Hispanic women. Despite effective interventions, many women die each year of breast and colorectal cancer, accounting for > 20% of all cancer deaths among United States women. An unequal number of these deaths occur among Black and Hispanic women who experience adverse social determinants of health (conditions in which people are born, grow, live, work and age). Addressing the barriers that limit cancer screening and genetic testing rates through patient navigation could improve outcomes in this population. Patient navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. This trial will test different approaches to cancer screening and genetic services navigation, such as multi-cancer and single site screening navigation, as well as different combinations of services offered. Researchers hope this will help identify which approach is most effective at addressing the barriers these women face and ultimately improve breast and colorectal cancer screening among Black/African American and Hispanic women.
Inclusion Criteria
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Seeking screening navigation services through programs at a participating site (Georgetown Lombardi Cancer Center or Helen F. Graham Cancer Center & Research Institutes)
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Eligible for breast cancer screening while also due and eligible for colorectal cancer screening (per United States Preventive Services Task Force [USPSTF] guidelines)
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Female sex
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Speak English or Spanish with enough fluency to complete study activities
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Stated willingness to comply with all study procedures (navigation, surveys) and availability for the duration of the study
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Provision of completed electronic informed consent form
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Completion of Screening Navigation Intervention, including completion of 6-month survey
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Opted-in to qualitative interview
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Stated willingness to comply with study procedures (interview, audio-recording) and availability
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Provision of completed verbal informed consent form
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Employed within navigation programs at a participating site (Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center & Research Institute); or as healthcare system leaders responsible for screening and genetic services processes, or staff responsible for scheduling and providing cancer screening and genetic services
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Over age 18
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Speak English or Spanish
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Stated willingness to comply with study procedures (survey, interview, audio-recording) and availability
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Provision of completed electronic informed consent form
Exclusion Criteria
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center & Research Institute
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Not eligible for breast cancer screening or not due and eligible for colorectal cancer screening (per USPSTF guidelines)
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: History of breast and/or colorectal cancer; or reporting symptoms related to breast and/or colorectal cancer (e.g., gastrointestinal [GI] bleeding, breast mass)
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Male sex, Intersex, or other sex
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Under age 45 or over age 74
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Identifies as neither Black/African American race nor Hispanic/Latin(e)(a) ethnicity
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Speaks neither English nor Spanish with enough fluency to complete study activities
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Stated unwillingness to comply with study procedures (navigation, surveys) or unavailability for the duration of the study
SCREENING NAVIGATION INTERVENTION PARTICIPANTS: Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Actively participating in the Screening Navigation Intervention
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Failure to complete all activities of the Screening Navigation Intervention, including incomplete 6-month follow-up survey
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Opted-out of qualitative interview
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Stated unwillingness to comply with study procedures (interview, audio-recording) or unavailability
PATIENT-FOCUSED PROCESS EVALUATION QUALITATIVE INTERVIEW PARTICIPANTS: Inability to provide verbal informed consent, or needing another person to authorize informed consent on their behalf
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Not currently employed at navigation programs at a participating site (Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center & Research Institute); nor as healthcare system leaders responsible for screening and genetic services processes, or staff responsible for scheduling and providing cancer screening and genetic services
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Under age 18
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Speaks neither English nor Spanish with enough fluency to complete study activities
ORGANIZATION-FOCUSED PROCESS EVALUATION PARTICIPANTS: Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07228000.
Locations matching your search criteria
United States
UNKNOWN
Helen F. Graham Cancer Center & Research Institute at Christiana Care
I. To test the efficacy for colorectal cancer screening and non-inferiority for breast cancer screening of bundled multicancer screening navigation.
SECONDARY OBJECTIVE:
I. To examine effect moderation of primary objectives.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To test efficacy for genetic counseling and testing are exploratory outcomes.
OUTLINE: Patients undergo familial cancer risk assessment during screening and are randomized to 1 of 2 arms.
ARM I: Patients receive single site breast cancer screening navigation on study consisting of education, barrier assessment and resolution, screening exam scheduling, text and mailed reminders, appointment completion assistance, screening result communication, and assessment of diagnostic needs as indicated. Patients who have not received colorectal cancer screening at 6 month follow up then receive colorectal cancer screening referral and navigation.
ARM II: Patients receive multi-cancer breast and colorectal cancer screening navigation on study consisting of education, barrier assessment and resolution, screening exam scheduling, text and mailed reminders, appointment completion assistance, screening result communication, and assessment of diagnostic needs as indicated.
All patients identified as eligible for genetic services during familial cancer risk assessment are further randomized to 1 of 2 arms.
ARM III: In addition to the single site or multi-cancer screening navigation (as per randomization), patients also receive usual care referral to genetic services and pre-counseling education materials via email on study.
ARM IV: In addition to the single site or multi-cancer screening navigation (as per randomization), patients also receive usual care referral to genetic services on study.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMedStar Georgetown University Hospital