Trial Outcomes & Findings for PeLear CCC: Proyecto Latino Contra Cancer Colorrectal (NCT NCT06426927)
NCT ID: NCT06426927
Last Updated: 2026-01-21
Results Overview
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.
COMPLETED
NA
60 participants
30 days after participation in Study Day 2
2026-01-21
Participant Flow
Participant milestones
| Measure |
Educational Videos
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).
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.
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|---|---|
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Overall Study
STARTED
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60
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Overall Study
COMPLETED
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60
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PeLear CCC: Proyecto Latino Contra Cancer Colorrectal
Baseline characteristics by cohort
| Measure |
Educational Videos
n=60 Participants
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).
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.
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Age, Continuous
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51.3 years
n=37 Participants
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Sex: Female, Male
Female
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31 Participants
n=37 Participants
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Sex: Female, Male
Male
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29 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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60 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=37 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=37 Participants
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Race (NIH/OMB)
White
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25 Participants
n=37 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=37 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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34 Participants
n=37 Participants
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Region of Enrollment
United States
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60 Participants
n=37 Participants
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PRIMARY outcome
Timeframe: 30 days after participation in Study Day 2Population: Per the protocol, a traditional "power analysis" is not directly applicable to the qualitative, semi-structured one-on-one interview aspect of the trial. Based on published methodologies to assess the adequate sample to reach "saturation", 20 participants were invited for qualitative interviews.
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.
Outcome measures
| Measure |
Educational Videos
n=20 Participants
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).
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.
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|---|---|
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Attitudes Regarding Participation in Clinical Trials-Conceptual Themes (General Clinical Trials)
Work is a priority
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85 percentage of participants
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Attitudes Regarding Participation in Clinical Trials-Conceptual Themes (General Clinical Trials)
Preference for communicating in Spanish
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80 percentage of participants
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PRIMARY outcome
Timeframe: 30 days after participation in Study Day 2Population: Per the protocol, a traditional "power analysis" is not directly applicable to the qualitative, semi-structured one-on-one interview aspect of the trial. Based on published methodologies to assess the adequate sample to reach "saturation", 20 participants were invited for qualitative interviews.
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.
Outcome measures
| Measure |
Educational Videos
n=20 Participants
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).
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.
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|---|---|
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Attitudes Regarding Participation in Cancer Clinical Trials-Conceptual Themes (Cancer Clinical Trials)
Knowledge is "peace of mind"
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45 percentage of participants
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Attitudes Regarding Participation in Cancer Clinical Trials-Conceptual Themes (Cancer Clinical Trials)
Fear of side effects
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60 percentage of participants
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PRIMARY outcome
Timeframe: 30 days after participation in Study Day 2Population: Per the protocol, a traditional "power analysis" is not directly applicable to the qualitative, semi-structured one-on-one interview aspect of the trial. Based on published methodologies to assess the adequate sample to reach "saturation", 20 participants were invited for qualitative interviews.
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.
Outcome measures
| Measure |
Educational Videos
n=20 Participants
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).
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.
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|---|---|
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Perceptions of Latino Community for Increasing Enrollment in Randomized Clinical Trials-Conceptual Themes (General Clinical Trials)
Go to where Latinos congregate
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90 percentage of participants
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Perceptions of Latino Community for Increasing Enrollment in Randomized Clinical Trials-Conceptual Themes (General Clinical Trials)
Video-based communication is preferred
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80 percentage of participants
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PRIMARY outcome
Timeframe: 30 days after participation in Study Day 2Twenty 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.
Outcome measures
| Measure |
Educational Videos
n=20 Participants
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).
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.
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Holistic Themes
Attitudes regarding Cancer CTs: "Peace of Mind vs. Bodily Invasion/Side Effects Influence Attitude"
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45 percentage of participants
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Holistic Themes
Perception of Clinical Trials (CTs): "Positives Outweigh the Negatives"
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58 percentage of participants
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Holistic Themes
Attitudes regarding CTs: "Factors Alleviating/ Exacerbating Fear Influence Attitude"
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100 percentage of participants
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SECONDARY outcome
Timeframe: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 daysUse 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.
Outcome measures
| Measure |
Educational Videos
n=60 Participants
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).
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.
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|---|---|
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Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
Study Day 1: Baseline
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4.10 score on a scale
Standard Error 0.36
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Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
Study Day 1: Post-video
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7.23 score on a scale
Standard Error 0.32
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Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms
Study Day 2: 30 +/- 7 days
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6.95 score on a scale
Standard Error 0.29
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SECONDARY outcome
Timeframe: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 daysUse 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.
Outcome measures
| Measure |
Educational Videos
n=60 Participants
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).
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.
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|---|---|
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Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
Study Day 1: Baseline
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3.06 score on a scale
Standard Error 0.08
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Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
Study Day 1: Post-video
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4.08 score on a scale
Standard Error 0.15
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Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors
Study Day 2: 30 +/- 7 days
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3.93 score on a scale
Standard Error 0.12
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SECONDARY outcome
Timeframe: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes); Study Day 2: 30 +/- 7 daysUse 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.
Outcome measures
| Measure |
Educational Videos
n=60 Participants
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).
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.
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|---|---|
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Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
Study Day 1: Baseline
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3.80 score on a scale
Standard Error 0.20
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Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
Study Day 1: Post-video
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6.05 score on a scale
Standard Error 0.20
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Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts
Study Day 2: 30 +/- 7 days
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5.12 score on a scale
Standard Error 0.22
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SECONDARY outcome
Timeframe: On Study Day 1: Immediately before (baseline) and immediately post-video (within 30 minutes) after the video projectionAppropriate 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.
Outcome measures
| Measure |
Educational Videos
n=60 Participants
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).
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.
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Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials
Study Day 1: Baseline
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55 Participants
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Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials
Study Day 1: Post-video
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54 Participants
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Adverse Events
Educational Videos
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
José Guillem, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place