PeLear CCC: Proyecto Latino Contra Cancer Colorrectal

Trial Title: PeLear CCC: Proyecto Latino Contra Cancer Colorrectal

NCT ID: NCT06426927

Condition: Colorectal Cancer
Rectal Cancer
Colon Cancer
Colon Rectal Cancer
Rectal Neoplasms
Colon Adenocarcinoma
Hereditary Nonpolyposis Colon Cancer

Conditions: Official terms:
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis

Conditions: Keywords:
Colorectal Cancer
Latinx
Barriers
Cancer Clinical Trials
Latino
Spanish
Familial Colorectal Cancer
Lynch Syndrome
Hispanic

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Colorectal Cancer Educational Videos in Spanish
Description: Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, facts, screening and treatment will be assessed before and immediately after the educational video and at 30 +/- 7 days. In addition, the association between increase in CRC knowledge and willingness to participate in Cancer Clinical Trials (CCT) will be explored.
Arm group label: Educational Videos

Summary: The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are 18 years or older and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs. It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, although Latino individuals are among the largest and fastest growing communities of color in the US, currently comprising 18.7%, their representation in CCTs remains low. This is of concern because: 1) advances arising from trials with limited Latino representation may not be applicable to the Latino population, and 2) decreased Latino participation in CCTs may delay Latino access to novel therapies in a timely fashion. The investigators conducting this study believe that low cancer-specific health knowledge may be impacting Latino representation and willingness to participate in CCTs and can be addressed through culturally and linguistically appropriate community-based educational interventions. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement.

Detailed description: This pilot project aims to address the Clinical and Translational Science (CTS) roadblock of underrepresentation of Latinos in cancer clinical trials (CCTs) through a community-based, culturally, and linguistically appropriate educational intervention aimed at increasing health knowledge on a specific cancer. Colorectal cancer (CRC) will be the "use case" and the church will be the venue for Latino recruitment. This project will lead to the identification of novel Latino-perceived barriers to CCT enrollment, which will be applicable in other fields of medicine aiming to increase Latino CCT enrollment. The investigators believe that one barrier to recruitment for CCTs is low health education, specifically regarding cancers affecting the community, such as CRC, a commonly diagnosed cancer in the US Latino population. Therefore, the hypothesis that an increase in health knowledge in Latinos on a specific cancer mediates a change in their willingness to participate in CCTs will be tested. To do this, three educational CRC videos in Spanish will be created. The first video will review CRC symptoms, the second video will review CRC risk factors while the third video will provide information on CRC facts, screening, treatment and CCTs. In addition, a translated, non-validated questionnaire based on 3 sub-scales from 2 CRC knowledge questionnaires previously validated in English will be developed and pilot tested. Therefore, the Specific Aims of this Pilot Project are to: 1. Identify novel Latino-perceived barriers to participation in CCTs. 2. Assess the association between an educational video and CRC knowledge. 3. Assess the potential relationship between an increase in health knowledge of a specific cancer via an educational video in Spanish and willingness to participate in CCTs. To achieve these aims, recruit 60 Latino, Spanish speaking attendees of the Saint Thomas More (STM) Church in Chapel Hill will be recruited. The study will consist of three Study Days: 1. Study Day 1: Enrolled participants will be asked to attend an educational session at STM Church. During the educational session their baseline knowledge on CRC and their baseline willingness to participate in CCTs will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational CRC videos in Spanish and then their CRC knowledge as well as their willingness to participate in CCTs will be reassessed. 2. Study Day 2: Thirty +/- 7 days after the educational session, participants will be asked to return to STM Church in order to complete a follow-up questionnaire in Spanish. The questionnaire will assess their level of retainment of CRC knowledge, their willingness to participate in CCTs as well as assess in an open-ended fashion their perceived barriers to CCT participation. 3. Study Day 3: Twenty of the 60 enrolled participants will be asked to participate in a qualitative one-on-one interview aimed at identifying Latino perceived barriers to CCT participation.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Spanish speaking - Identifying as Latino - 18 years or older Exclusion Criteria: - Non-Spanish speakers - Not identifying as Latino - Younger than 18 years old

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Saint Thomas More Church

Address:
City: Chapel Hill
Zip: 27514
Country: United States

Status: Recruiting

Contact:
Last name: Jose G Guillem, MD, MPH, MBA

Phone: 919-966-8436
Email: jose_guillem@med.unc.edu

Contact backup:
Last name: Dimitrios Varvoglis, MD

Phone: 919-966-8436
Email: dimitrios_varvoglis@med.unc.edu

Start date: October 27, 2024

Completion date: March 31, 2025

Lead sponsor:
Agency: University of North Carolina, Chapel Hill
Agency class: Other

Collaborator:
Agency: North Carolina Translational and Clinical Sciences Institute
Agency class: Other

Source: University of North Carolina, Chapel Hill

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06426927
https://www.cancerresearchuk.org/sites/default/files/health_professional_bowel_cam_toolkit_version_2.1_09.02.11.pdf
https://www.census.gov/library/stories/2021/08/improved-race-ethnicity-measures-reveal-united-states-population-much-more-multiracial.html
https://report.nih.gov/sites/report/files/docs/NCITriennialInclusionReportFY2019_FY2021Final.pdf