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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-02710 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19PS-24-8 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source | |
| U2CCA252971-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests how well an educational program for training Hispanic/Latino/a (H/L) community members regarding colorectal cancer genetics works to increase knowledge about genetic and genomic testing. H/L populations are underrepresented in colorectal cancer tumor and genetics studies due to lack of access of patients in clinical genetic testing, very low participation in clinical trials, lack of knowledge about cancer genetics and genomics, and lack of culturally sensitive materials for patient engagement in cancer genetics and genomic research. The community genetic navigation engagement specialist training program may increase knowledge regarding colorectal cancer genetics in H/L communities.
PRIMARY OBJECTIVES:
I. To evaluate a genetic education program for H/L community health educators to train them as Community Genetic Navigation Engagement Specialists (CoGENES).
II. To evaluate a culturally tailored CoGENES Educational Tool Kit for H/L communities on genetic research, genetic counseling, and cancer risk assessments to be used by the CoGENES trainees to disseminate to community agencies.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of the CoGENES Educational program to improve the confidence of community health educators to train others in the community, as demonstrated by:
Ia. Self-confidence delivering training survey scores; Ib. Number of educators trained by each CoGENES; Ic. As well as the number of people reached in the community at large.
OUTLINE: Participants are assigned to 1 of 3 groups.
PHASE 1: 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.
PHASE 2: 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.
FOCUS GROUP: Participants attend a focus group, over 60-90 minutes, on study.
After completion of study intervention, participants in phase I and II are followed up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (Focus group) | Other | Participants attend a focus group, over 60-90 minutes, on study. |
|
| Phase I (Education) | Experimental | 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. |
|
| Phase II (Training, education) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Other | Attend focus group |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who completed training program | Will report the number of participants started and number of participants who successfully completed the training program. Training is considered successful if they complete the required number of hours. Training lasts 3 hours per session once a week over 6 weeks. We will recruit 10-12 trainees per year for 3 years. | Up to 36 months |
| Knowledge gained after training | After training, participants will be assessed about their knowledge of genetic testing before training new trainees and educating community members. Will use the Genetic Literacy and Comprehension (GLAC) measure to assess trainees knowledge with eight commonly used genetic terms and concepts (genetic, chromosome, susceptibility, mutation, variation, abnormality, heredity, and sporadic) using a 7-point scale of 1 "Strongly Disagree" to 7 "Strongly Agree". We will compare pre- and post- surveys to assess knowledge. | Up to 36 months |
| Confidence of training after training completion | Measured by scores obtained from questioners developed by our team to capture confidence level of participants in training peers, focusing on confidence of explaining each module of the program to prospective trainees and answering questions, as well as confidence level using our Educational Toolkit to educate the community at large. Higher scores mean more confidence. | Up to 36 months |
| Number of people trained and/or reached in the community | Will report number of people trained and/or reached in the community | At 6 and 12 month follow up |
| Completion of focus groups | Will focus on readability, knowledge, acceptability, barriers. These qualitative analyses focus on the educational materials themselves, and their ability to transfer knowledge in the most effective way, as well as assessing the effectiveness of the materials in transferring information that is understandable, readable and usable for participants to train others. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourdes Baezconde-Garbanati | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States | ||
| USC / Norris Comprehensive Cancer Center |
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| Educational Intervention | Other | Complete educational sessions |
|
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| Educational Intervention | Other | Train participants |
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| Interview | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Up to 2 years |
| Los Angeles |
| California |
| 90033 |
| United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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