An interventional study of Colorectal Cancer Educational Videos in Spanish in Colorectal Cancer, Rectal Cancer and Colon Cancer, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other
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.
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:
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:
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
Enrolled participants will watch three educational videos in Spanish pertaining to: (1) Colorectal Cancer (CRC) symptoms; (2) CRC risk factors and (3) CRC facts, screening, treatment, and Cancer Clinical Trials (CCT).
Other: Colorectal Cancer Educational Videos in Spanish
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.
Attitudes Regarding Participation in Clinical Trials-Conceptual Themes (General Clinical Trials)
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for attitudes regarding general clinical trials will be reported in terms of percentage of participants.
Time frame: 30 days after participation in Study Day 2
Attitudes Regarding Participation in Cancer Clinical Trials-Conceptual Themes (Cancer Clinical Trials)
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for attitudes regarding cancer clinical trials will be reported in terms of percentage of participants.
Time frame: 30 days after participation in Study Day 2
Perceptions of Latino Community for Increasing Enrollment in Randomized Clinical Trials-Conceptual Themes (General Clinical Trials)
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for perceptions of the Hispanic/Latino community will be reported in terms of percentage of participants.
Time frame: 30 days after participation in Study Day 2
Holistic Themes
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 3 holistic themes will be reported in terms of percentage of participants.
Time frame: 30 days after participation in Study Day 2
Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) symptoms will be assessed using the "Knowledge of Warning Signs" questions from the "Bowel Cancer Awareness Measure". Potential answers include "Yes", "No" and "Don't Know". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.
Time frame: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days
Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
Use of appropriate statistical measures to compare mean of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) risk factors will be assessed using the "Knowledge of Risk Factors" questions from the "Bowel Cancer Awareness Measure". This scale is measured using a Likert 1-5 scale with "1" corresponding to "Strongly Disagree" and "5" corresponding to "Strongly Agree". The overall score will range from 1 to 5 and it is anticipated that the average scores will increase after the intervention. Higher scores imply greater knowledge of risk factors.
Time frame: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days
Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
Use of appropriate statistical measures to compare mean of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (CRC) screening and general facts will be assessed using nine questions from the "Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of colorectal cancer screening and facts.
Time frame: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 days
Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials
Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of Study Day 1 post-video health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size. The number of participants who responded "Yes" to willingness to participate in cancer clinical trials are reported in the data table.
Time frame: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes) after the video projection
| Milestone | Educational Videos |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for attitudes regarding general clinical trials will be reported in terms of percentage of participants.
| percentage of participants | Educational Videos |
|---|---|
| Work is a priority | 85 |
| Preference for communicating in Spanish | 80 |
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for attitudes regarding cancer clinical trials will be reported in terms of percentage of participants.
| percentage of participants | Educational Videos |
|---|---|
| Fear of side effects | 60 |
| Knowledge is "peace of mind" | 45 |
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes for perceptions of the Hispanic/Latino community will be reported in terms of percentage of participants.
| percentage of participants | Educational Videos |
|---|---|
| Go to where Latinos congregate | 90 |
| Video-based communication is preferred | 80 |
Twenty participants were invited for qualitative interviews. Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 3 holistic themes will be reported in terms of percentage of participants.
| percentage of participants | Educational Videos |
|---|---|
| Perception of Clinical Trials (CTs): "Positives Outweigh the Negatives" | 58 |
| Attitudes regarding CTs: "Factors Alleviating/ Exacerbating Fear Influence Attitude" | 100 |
| Attitudes regarding Cancer CTs: "Peace of Mind vs. Bodily Invasion/Side Effects Influence Attitude" | 45 |
Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) symptoms will be assessed using the "Knowledge of Warning Signs" questions from the "Bowel Cancer Awareness Measure". Potential answers include "Yes", "No" and "Don't Know". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.
| score on a scale | Educational Videos |
|---|---|
| Study Day 1: Baseline | 4.10 ± 0.36 |
| Study Day 1: Post-video | 7.23 ± 0.32 |
| Study Day 2: 30 +/- 7 days | 6.95 ± 0.29 |
Use of appropriate statistical measures to compare mean of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) risk factors will be assessed using the "Knowledge of Risk Factors" questions from the "Bowel Cancer Awareness Measure". This scale is measured using a Likert 1-5 scale with "1" corresponding to "Strongly Disagree" and "5" corresponding to "Strongly Agree". The overall score will range from 1 to 5 and it is anticipated that the average scores will increase after the intervention. Higher scores imply greater knowledge of risk factors.
| score on a scale | Educational Videos |
|---|---|
| Study Day 1: Baseline | 3.06 ± 0.08 |
| Study Day 1: Post-video | 4.08 ± 0.15 |
| Study Day 2: 30 +/- 7 days | 3.93 ± 0.12 |
Use of appropriate statistical measures to compare mean of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (CRC) screening and general facts will be assessed using nine questions from the "Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of colorectal cancer screening and facts.
| score on a scale | Educational Videos |
|---|---|
| Study Day 1: Baseline | 3.80 ± 0.20 |
| Study Day 1: Post-video | 6.05 ± 0.20 |
| Study Day 2: 30 +/- 7 days | 5.12 ± 0.22 |
Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of Study Day 1 post-video health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size. The number of participants who responded "Yes" to willingness to participate in cancer clinical trials are reported in the data table.
| Participants | Educational Videos |
|---|---|
| Study Day 1: Baseline | 55 |
| Study Day 1: Post-video | 54 |
Collected over Adverse Events were monitored from the time of signing informed consent through study completion, up to 30 days for participants involved in the educational video only and up to 60 days for those who participated in the qualitative interviews.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Educational Videos | — | — | 0/60 (0%) |
| Age, Continuous(years) | Educational Videos |
|---|---|
| Mean | 51.3 (20 to 73) |
| Sex: Female, Male(Participants) | Educational Videos |
|---|---|
| Female | 31 |
| Male | 29 |
| Ethnicity (NIH/OMB)(Participants) | Educational Videos |
|---|---|
| Hispanic or Latino | 60 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Educational Videos |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 1 |
| Unknown or Not Reported | 34 |
| Region of Enrollment(Participants) | Educational Videos |
|---|---|
| United States | 60 |
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University of North Carolina, Chapel Hill