Educational Intervention for Colorectal Cancer Screening

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Does not meet inclusion criteria

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to educate people about colorectal cancer and the importance of screening. It offers educational sessions, known as the Educational Intervention, covering screening methods such as the FIT kit (a home test for blood in stool) and colonoscopy. The goal is to increase participants' knowledge and encourage screening. Individuals living in the Tampa Bay area, who speak English or Spanish, and are between 45 and 75 years old may be suitable for this trial. As an unphased study, this trial provides a valuable opportunity to learn about colorectal cancer screening and take proactive steps for health.

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 seems to focus on educational materials rather than medical treatments, so you likely won't need to change your medications.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs, such as patient navigation, are safe for individuals. These programs guide and support patients through the healthcare system, particularly for cancer screenings. Studies have found that patient navigation services increase the number of people screened for colorectal cancer without causing harm. Reports of negative effects from these educational programs do not exist. Overall, these programs are well-received and aim to improve knowledge and access to screening services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Intervention for Colorectal Cancer Screening because it emphasizes personalized education and easy access to screening resources. Unlike traditional methods, which often rely solely on physician recommendation, this intervention provides colorectal cancer education in various formats—such as in-person, online, and by phone—making it more accessible and adaptable to individual needs. Additionally, it helps participants navigate the screening process by connecting them with resources, especially those without primary care providers, through Federally Qualified Health Centers. This tailored approach has the potential to increase screening rates and early detection, ultimately improving outcomes for colorectal cancer.

What evidence suggests that this educational intervention is effective for increasing colorectal cancer screening rates?

This trial will evaluate an educational intervention designed to increase colorectal cancer screening rates. Research has shown that educational programs can boost the number of people getting screened for colorectal cancer. Studies have found that clear information and guidance about screenings make individuals more likely to complete tests like the fecal immunochemical test (FIT) or a colonoscopy. For instance, patient navigation, which helps people understand and access screening services, has improved screening rates. A review of multiple studies found that this support significantly increases the number of people who get screened and follow up after abnormal results. Overall, educational efforts play a crucial role in encouraging people to get screened for colorectal cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Clement K Gwede, PhD, MPH, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Cathy D Meade, PhD, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers living in the Tampa Bay area (Hillsborough, Pinellas, Polk, or Pasco county), aged between 45 and 75 years old who can consent to participate. It's not open to those outside this age range or location.

Inclusion Criteria

Able to provide informed consent

Reside in the Tampa Bay area (namely Hillsborough, Pinellas, Polk or Pasco county)

I am between 45 and 75 years old.

Exclusion Criteria

Does not meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive educational materials and information regarding colorectal cancer, screenings, and recommendations

1 week

1 session (in-person, virtual, or phone)

Follow-up

Participants complete pre and post assessment surveys and follow-up surveys to assess knowledge and behavior changes

6 months

Surveys at baseline, immediately post-intervention, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention

Trial Overview The study provides educational materials about colorectal cancer and screening based on US Preventive Services Task Force recommendations. The goal is to see if these interventions increase awareness and screenings among participants.

How Is the Trial Designed?

Group I: Educational Intervention and Referral for Fecal Immunochemical Test (FIT) Kit or Colonoscopy Experimental Treatment 1 Intervention

The Community Health Educator (CHE) will provide online, phone or in-person colorectal cancer (CRC) early detection, prevention, and screening education to increase knowledge of CRC and the importance of screening. These sessions will be conducted in small in-person sessions, virtually within a group, virtually via a self-paced/self-directed online learning module, or one-on-one via phone. Additionally, the CHE will provide information regarding FIT kit and colonoscopy screening and the screening process for attendees. The CHE and research assistant will be prepared to provide access to screening resources and services through participants' existing coverage. Those participants who do not have a primary care provider will be provided information on obtaining FIT kits through the mechanisms of the Federally Qualified Health Center (FQHC) and/or a colonoscopy through the cancer center on a case by case basis.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5487219/

Characteristics of Effective Colorectal Cancer Screening ... Colorectal cancer (CRC) screening outcomes needed to be evidenced by completion of a fecal occult blood test (FOBT), flexible sigmoidoscopy, or a colonoscopy.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831644

Mailed Outreach and Patient Navigation for Colorectal ... Patient navigation has also been shown to improve rates of CRC screening and follow-up after abnormal test results. In a 2020 meta-analysis, ...

4. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-colorectal-cancer-screening.html

Colorectal Cancer Screening: Patient Navigation The systematic economic review finds patient navigation services to increase colorectal cancer screening are cost-effective with three studies' estimates of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03200366

Comparing Interventions to Increase Colorectal Cancer ... The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01141114

Study of Patient Navigation to Promote Colon Cancer ... A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...

7. academic.oup.com academic.oup.com/jnci/article/115/6/680/7050938

Characteristics of patient navigation programs in the Cancer ... Patient navigation is an evidence-based intervention that has been shown to substantially improve rates of colorectal cancer (CRC) screening and ...

8. formative.jmir.org formative.jmir.org/2024/1/e53224

The Development of a Digital Patient Navigation Tool to ... This study conducts user testing of a digital patient navigation tool, called eNav, designed to support FQHC patients in preparing for, requesting, and ...