Colorectal Carcinoma
Conditions
Brief summary
This clinical trial evaluates the effectiveness of trained community engagement specialists for improving communication on colorectal cancer (CRC) prevention and genetic testing among Hispanic/Latino/a/x (H/L) communities. CRC is the second and third leading cause of cancer deaths among United States (US) H/L men and women respectively. Knowledge of inherited germline mutations (changes in a gene that occurs in a sperm or egg cell) is critical for understanding cause of disease and can impact patient treatment options and outcomes. Educational programs and participant engagement approaches focused on H/L individuals considering Latino cultural values, literacy, numeracy, barriers faced, cultural beliefs and attitudes, as well as language of participants are much needed to address these observed disparities. The Community Genetic Navigation Specialists (CoGENES) Program focuses on increasing knowledge, and preparing the CoGENES trainees to help respond to questions, fears, and concerns regarding genetic testing, counseling, biospecimen (sample of urine, blood, or tissue cells) donation and participation in clinical trials to H/L community members, patients and their families. CoGENES may improve communication on colorectal cancer prevention and genetic testing which can help reduce cancer disparities among H/L communities.
Detailed description
PRIMARY OBJECTIVE: I. To develop a local workforce of trained community engagement specialists to act as liaison agents to improve communication on genetic research, clinical genetic testing, and counseling to Hispanic/Latino/a/x (H/L) individuals. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP 1: Participants receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing to review at their own pace over 6-10 weeks. Participants may optionally receive a CoGENES training session within 2 weeks post-intervention. GROUP 2: Participants receive a CoGENES training session over 45-60 minutes. After completion of study intervention, participants are followed up at 8 weeks, 6 months and 12 months.
Interventions
OTHERBest Practice
Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing
OTHERHealth Promotion and Education
Receive CoGENES training
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Southern California
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be 18 years of age or older * Ability to understand and the willingness to sign a written informed consent * Self-reported H/L ethnicity, of any race * Ability to read, write, and speak Spanish or English * Resides in Los Angeles County
Exclusion criteria
* Anyone younger than 18 years of age * Any person with major cognitive deficit or psychiatric impairment * Any person unable to read and write Spanish or English * Resides outside of Los Angeles County * Any person who considers themselves a community health educator or "promotor/a de salud" and/or has taken in the past three years training on colorectal cancer and/or cancer genetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in knowledge about colorectal cancer prevention | Baseline to 12 months | We will use the WCRF/AICR score, which is a standardized scoring system, typically ranging from 0 to 7 points, that measures an individual's adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for cancer prevention. A higher score indicates greater compliance with lifestyle factors like maintaining a healthy weight, engaging in physical activity, eating a diet rich in plant-based foods, and limiting alcohol, fast food, and sugary drinks. We will compare pre- and post-intervention to assess knowledge. |
| Change in knowledge about genetic testing | Baseline to 12 months | Will use the Genetic Literacy and Comprehension (GLAC) measure to assess participant 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. |
| Change in knowledge about tumor testing | Baseline to 12 months | Will assess participants knowledge about tumor testing as determined by scores obtained from validated surveys. Will compare pre- and post- surveys to assess knowledge. Higher scores mean better knowledge. |
| Change in knowledge about genetic counseling | Baseline to 12 months | There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire will be administered at pre- and post-genetic education. |
| Changes in dietary and lifestyle patterns | Baseline to 12 months | Measured by scores obtained from surveys developed for this study. Will compare pre- and post- surveys to evaluate changes. Higher scores mean positive changes. |
| Intention to pursue colorectal cancer screening | Up to 12 months | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). |
| Intention to inquire about cancer history among family members | Up to 12 months | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). |
| Intention to ask healthcare provider about genetic testing and counseling | Up to 12 months | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana C Stern, PhD
University of Southern California
Outcome results
None listed