Colorectal CarcinomaNCT07229443
CoGENES Randomized Controlled Trial (RCT)
A study testing Best Practice, Health Promotion and Education and Survey Administration in people with Colorectal Carcinoma, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Best Practice, Health Promotion and Education and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Evaluation of a Colorectal Cancer Education Training Program
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Colorectal Carcinoma
- Being tested
- Best Practice, Health Promotion and Education, Survey Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing
Health Promotion and EducationOther
Receive CoGENES training
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (usual care) | Active comparator | 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. Receives: Other: Best Practice; Other: Survey Administration |
| Group 2 (CoGENES) | Experimental | Participants receive a CoGENES training session over 45-60 minutes. Receives: Other: Health Promotion and Education; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge about colorectal cancer prevention
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.
Measured: Baseline to 12 months
Change in knowledge about genetic testing
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.
Measured: Baseline to 12 months
Change in knowledge about tumor testing
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.
Measured: Baseline to 12 months
Change in knowledge about genetic counseling
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.
Measured: Baseline to 12 months
Changes in dietary and lifestyle patterns
Measured by scores obtained from surveys developed for this study. Will compare pre- and post- surveys to evaluate changes. Higher scores mean positive changes.
Measured: Baseline to 12 months
Intention to pursue colorectal cancer screening
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).
Measured: Up to 12 months
Intention to inquire about cancer history among family members
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).
Measured: Up to 12 months
Intention to ask healthcare provider about genetic testing and counseling
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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mariana C Stern, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229443
- Sponsor's protocol ID
- 19PS-24-7
- Other IDs
- NCI-2025-02815, 19PS-24-7, P30CA014089, U2CCA252971-01
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Colorectal Cancer Education Training Program
- ClinicalTrials.gov ID
- NCT07229443
- Acronym / sponsor ID
- 19PS-24-7
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (usual care) | Active comparator | Other: Best Practice, Other: Survey AdministrationParticipants 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 (CoGENES) | Experimental | Other: Health Promotion and Education, Other: Survey AdministrationParticipants receive a CoGENES training session over 45-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing | Other | Group 1 (usual care) |
| Health Promotion and EducationReceive CoGENES training | Other | Group 2 (CoGENES) |
| Survey AdministrationAncillary studies | Other | Group 1 (usual care), Group 2 (CoGENES) |
Primary outcome
Change in knowledge about colorectal cancer prevention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana C Stern, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Health Promotion and Education and Survey Administration in people with Colorectal Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge about colorectal cancer prevention (time frame: Baseline to 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.