Clinical trial NCT06426927: PeLear CCC: Proyecto Latino Contra Cancer Colorrectal
Official title: A Colorectal Cancer Educational Intervention in the Latino Community Assessing the Feasibility of Recruitment & Retention Via a Church-Based Approach: Identification of Novel Barriers to Cancer Clinical Trial Enrollment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Rectal Cancer
Colon Cancer
Colon Rectal Cancer
Rectal Neoplasms
Colon Adenocarcinoma
Hereditary Nonpolyposis Colon Cancer
Keywords: Colorectal Cancer
Latinx
Barriers
Cancer Clinical Trials
Latino
Spanish
Familial Colorectal Cancer
Lynch Syndrome
Hispanic
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2024-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Barriers Preventing Latinos from Participating in Cancer Clinical Trials
timeFrame: 30 days after participation in Study Day 2
Secondary outcomes:
measure: Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
timeFrame: On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
measure: Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
timeFrame: On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
measure: Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
timeFrame: On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
measure: Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials
timeFrame: On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Saint Thomas More Church
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: José G. Guillem, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sepucha KR, Feibelmann S, Cosenza C, Levin CA, Pignone M. Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions. BMC Med Inform Decis Mak. 2014 Aug 20;14:72. doi: 10.1186/1472-6947-14-72.
citation: American Cancer Society. Cancer Facts & Figures for Hispanic/Latino People 2021-2023. Atlanta: American Cancer Society, Inc. 2021.
citation: Power E, Simon A, Juszczyk D, Hiom S, Wardle J. Assessing awareness of colorectal cancer symptoms: measure development and results from a population survey in the UK. BMC Cancer. 2011 Aug 23;11:366. doi: 10.1186/1471-2407-11-366.