Health TrialsbyHealthPanel

CoGENES Randomized Controlled Trial (RCT)

ConditionColorectal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing

  • Health Promotion and Education

    Other intervention

    Receive CoGENES training

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Group 1 (usual care)Active comparator 2 interventions
Group B: Group 2 (CoGENES)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 12 months
2

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.

Time frame
Baseline to 12 months
3

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.

Time frame
Baseline to 12 months
4

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.

Time frame
Baseline to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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