Cancer Screening and Genetic Services for Breast and Colon Cancer

Not yet recruiting at 1 trial location

Overseen By Chiranjeev Dash, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: History of cancer, Male sex, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to improve screening for both breast and colon cancer. It examines whether combining assistance for both screenings and providing education about genetic services enhances the process for patients. The trial targets Black or Hispanic/Latina women, aged 45 to 74, who require both breast and colon cancer screenings and use specific cancer centers for these services. As an unphased trial, it presents a unique opportunity to enhance cancer screening processes and access to genetic education for underserved communities.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this bundled cancer screening and genetic services navigation is safe?

In a previous study, researchers tested the effectiveness of combining cancer screenings and genetic services, focusing on breast and colon cancer screenings.

Specific safety information isn't available, but this type of study is usually labeled "Not Applicable" for phase. This is because it doesn't test a drug or device that might cause side effects; instead, it examines the process of screening and education.

Other studies on similar screening methods have not reported safety issues. Since these services involve screenings and education, they are generally considered safe and manageable. There have been no reports of problems caused by the screenings themselves.

Overall, this combined approach appears to be a safe way to help people understand their cancer risk and the importance of regular screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these services because they offer a comprehensive approach to cancer screening and genetic services that could significantly enhance early detection and personalized care. Unlike the standard of care, which often involves separate and sequential steps for screening and genetic counseling, this approach bundles these services with navigation support. This integration not only streamlines the process but also provides patients with pre-test education and navigation through multicancer screening options, potentially leading to more timely interventions and better outcomes. By combining these elements, this method aims to improve patient engagement and adherence, ultimately optimizing the screening and prevention landscape for breast and colon cancer.

What evidence suggests that this trial's treatments could be effective for breast and colon cancer?

This trial will evaluate different approaches to cancer screening and genetic services for breast and colon cancer. Studies have shown that combining screenings for breast and colorectal cancers can increase the number of people getting tested. For example, one study found that 38.7% of participants completed both tests when offered enhanced care options. This method is gaining popularity because it allows individuals to be screened for multiple cancers simultaneously. The combined services also include genetic counseling, which helps individuals understand their cancer risks based on family history. This is crucial because knowing one's risk can lead to early detection or even prevention of cancer. Participants in this trial will be assigned to different arms, such as usual care breast cancer screening navigation or multicancer screening navigation, with some arms also including genetic referral and pretest education. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals at risk of breast and colon cancer due to genetic susceptibility. It's designed to assess the effectiveness of bundled familial cancer risk assessment and navigation services for multiple cancers compared to single-cancer navigation or usual care.

Inclusion Criteria

I am willing and able to follow all study requirements and be available for its duration.

I am female.

Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity

Exclusion Criteria

Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center & Research Institute

I am not due for breast cancer screening but eligible for colorectal cancer screening.

I have had breast or colorectal cancer, or I have symptoms like GI bleeding or a breast mass.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Randomization

Research staff obtain consent and HIPAA authorization, proceeding with baseline assessment and randomization, stratified by site and genetics eligibility.

2 weeks

Navigation

Participants receive either multicancer or single cancer navigation, with a wait list control for colorectal cancer screening referral and navigation.

6 months

Follow-up

Participants are monitored for receipt of colorectal and breast cancer screenings, as well as genetic testing and counseling.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bundled Cancer Screening and Genetic Services Navigation

Trial Overview The study compares two approaches: one group receives guidance on screening for both colorectal and breast cancer, while another gets help only for breast cancer. A control group waits for colorectal screening referral. Additionally, it tests standard genetics referrals against enhanced pretest education plus referral.

How Is the Trial Designed?

Group I: Usual care breast cancer screening navigation + usual care genetic referral Experimental Treatment 2 Interventions

Group II: Usual care breast cancer screening navigation + pretest education/usual care genetic referral Experimental Treatment 2 Interventions

Group III: Usual care breast cancer screening navigation Experimental Treatment 1 Intervention

Group IV: Multicancer screening navigation + usual care genetic referral Experimental Treatment 2 Interventions

Group V: Multicancer screening navigation + pretest education/usual care genetic referral Experimental Treatment 2 Interventions

Group VI: Multicancer screening navigation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07228000

Bundled Cancer Screening and Genetic Services Navigation The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer ...

2. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=11116110&term=CA301168

Division of Cancer Control & Population Sciences - Grant Details We will test the bundling of multicancer prevention services in two community breast cancer screening navigation programs aligned with NCI-recognized ...

3. reporter.nih.gov reporter.nih.gov/project-details/10798287

Project Details - NIH RePORTER PROJECT NARRATIVE The WISDOM study is a pragmatic trial designed to improve screening by harnessing our growing understanding of breast cancer risk and ...

4. researchgate.net researchgate.net/publication/277354344_Joint_breast_and_colorectal_cancer_screenings_in_medically_underserved_women

Joint breast and colorectal cancer screenings in medically ... Results: Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116362/

Bundling Colorectal Cancer Screening Outreach ... Models for “bundled” screening, linking one cancer screening test with other services, have gained attention for their potential as an effective ...

6. reporter.nih.gov reporter.nih.gov/search/12EFCD0B4A8DC6D57598B8961CAA4A01A2FFCEB861BF/project-details/11116110

Bundled Multicancer Screening and Genetic Services ... We will test the bundling of multicancer prevention services in two community breast cancer screening navigation programs aligned with NCI-recognized ...

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34482

What happens in the long term: Uptake of cancer surveillance ... The purpose of this study was to measure the long-term utilization of targeted cancer prevention and quality of life among at-risk relatives ...