Educational Program for Colorectal Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Under 18, Cognitive deficit, Psychiatric impairment

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively an educational program increases knowledge about colorectal cancer genetics among Hispanic/Latino/a (H/L) communities. The program trains community members to become Genetic Navigation Engagement Specialists, who then educate others in their community. Participants engage in educational sessions and focus groups to learn and share information about cancer genetics. Individuals who identify as Hispanic/Latino/a, speak English or Spanish, and have an interest in learning about cancer genetics may be well-suited for this trial. As an unphased study, this trial provides a unique opportunity to contribute to community health education and empowerment.

What prior data suggests that this educational program is safe?

Research has shown that using Community Genetic Navigation Engagement Specialists in programs like this one is generally safe. These specialists help people understand the genetics of colorectal cancer. The program emphasizes education, not medical procedures, so it poses no physical risks.

In other studies, these trained specialists improved communication about colorectal cancer without any reported issues. This type of educational program has been used in similar settings, and participants have responded well. The specialists guide and support, ensuring a safe and informative experience for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to educating patients about colorectal cancer genetics through a community-driven model. Unlike traditional methods, which typically rely on healthcare providers for education, this program empowers participants who have completed initial training to teach others. This peer-led model could increase engagement and understanding by creating a supportive learning environment. The trial also leverages technology, offering virtual check-ins, which could make it more accessible to a broader audience. By involving the community and using innovative educational techniques, this trial aims to enhance awareness and early detection of colorectal cancer, potentially leading to better outcomes.

What evidence suggests that this educational program is effective for increasing knowledge about colorectal cancer genetics?

Research has shown that trained Community Genetic Navigation Engagement Specialists can help people learn about the genetics of colorectal cancer. In this trial, participants in the Phase I arm will complete educational sessions on colorectal cancer genetics. One study found that these specialists boost confidence in understanding genetic information. Participants in similar programs reported improved ability to discuss colorectal cancer and genetic testing. The program also aims to help participants teach others, as demonstrated in the Phase II arm, where participants who completed Phase I will train additional participants. These findings suggest that the educational program could effectively increase understanding of colorectal cancer genetics in Hispanic/Latino/a communities. ^{1 2 3 6 7}

Who Is on the Research Team?

Lourdes Baezconde-Garbanati

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino/a community members. It aims to educate them about colorectal cancer genetics, addressing the low participation in genetic studies and trials due to lack of access, knowledge, and culturally sensitive materials.

Inclusion Criteria

I am 18 years old or older.

Ability to understand and the willingness to sign a written informed consent

Self-reported H/L ethnicity, of any race

Exclusion Criteria

I am under 18 years old.

Any person with major cognitive deficit or psychiatric impairment

Any person unable to read English or Spanish, and/or unable to write English or Spanish (for surveys participants only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Education

Participants complete educational sessions regarding colorectal cancer genetics over 3 hours each, one to two times per week, for a total of 18 hours over 3-6 weeks. Participants may attend virtual check-in meetings over 30-60 minutes each month.

3-6 weeks

1-2 visits per week (virtual)

Phase II Training

Participants who completed phase I train additional participants via educational sessions regarding colorectal cancer genetics. New phase II participants attend the educational sessions regarding colorectal cancer genetics, led by phase I participants, over a total of 10-18 hours.

Varies

Monthly virtual check-ins

Focus Group

Participants attend a focus group, over 60-90 minutes, on study.

1 session

1 visit (in-person or virtual)

Follow-up

Participants are monitored for outcomes such as confidence and knowledge gained after training, with follow-ups at 6 and 12 months.

12 months

Follow-up at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Genetic Navigation Engagement Specialists

Trial Overview The intervention being tested is an educational program that includes discussions, interviews, surveys, and other educational activities. The goal is to train individuals on colorectal cancer genetics to increase awareness and knowledge within H/L communities.

How Is the Trial Designed?

Group I: Phase II (Training, education) Experimental Treatment 3 Interventions

Participants who completed phase I train additional participants via educational sessions regarding colorectal cancer genetics. New phase II participants attend the educational sessions regarding colorectal cancer genetics, led by phase I participants, over a total of 10-18 hours. Participants may attend virtual check-in meetings over 30-60 minutes each month.

Group II: Phase I (Education) Experimental Treatment 3 Interventions

Participants complete educational sessions regarding colorectal cancer genetics over 3 hours each, one to two times per week, for a total of 18 hours over 3-6 weeks. Participants may attend virtual check-in meetings over 30-60 minutes each month. Participants who complete the training program may then participate in phase II.

Group III: Observational (Focus group) Experimental Treatment 1 Intervention

Participants attend a focus group, over 60-90 minutes, on study.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07276048

Community Genetic Navigation Engagement Specialists to ... The community genetic navigation engagement specialist training program may increase knowledge regarding colorectal cancer genetics in H/L ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07229443

Study Details | NCT07229443 | Community Genetic ... This clinical trial evaluates the effectiveness of trained community engagement specialists for improving communication on colorectal cancer ...

3. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/6131/740283/Abstract-6131-Increasing-self-efficacy-self

Abstract 6131: Increasing self efficacy, self confidence, and ... Increasing self efficacy, self confidence, and genetic knowledge via the Community Genetic Navigation Engagement Specialist Train-the-Trainer ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT07276048

Community Genetic Navigation Engagement Specialists to ... Measured by scores obtained from questioners developed by our team to capture confidence level of participants in training peers, focusing on confidence of ...

5. withpower.com withpower.com/trial/phase-colorectal-neoplasms-5-2024-27fb9

Community Program for Colorectal Cancer Prevention This trial aims to evaluate how effectively trained community specialists can enhance communication about preventing colorectal cancer and genetic testing ...

6. mdpi.com mdpi.com/2072-6694/17/21/3590

Qualitative Outcomes of Colorectal Cancer Screening ... Among those with abnormal FITs, 50% received navigation, and 23% completed diagnostic colonoscopy. While higher-risk patients received navigation, none ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10185972/

Implementation of a Population-Based Cancer Family ... This program screened 212,827 individuals, over half of whom were considered underserved, and identified 133 clinically actionable genetic ...