Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426927
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-08
Brief Title:
PeLear CCC Proyecto Latino Contra Cancer Colorectal
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeLear CCC
Brief Summary:
The study aims to recruit 60 Spanish speaking individuals who identify as Latinos are older than 18 years old 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 187 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
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 187 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 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 Explore 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
4 Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos
5 Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire
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
1 Identify novel Latino-perceived barriers to participation in CCTs
2 Assess the association between an educational video and CRC knowledge
3 Explore 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
4 Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos
5 Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTSC0205 | OTHER_GRANT | NCTraCS Institute | None |