Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities

Colorectal Cancer Clinical Trial

Official title:

CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100254
• Other study ID #: I 159309
• Secondary ID: NCI-2013-01707I
• Status: Completed
• Phase: N/A
• Start date: October 1, 2009
• Est. completion date: September 23, 2017

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.

Description:

PRIMARY OBJECTIVES: I. Assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for African Americans in the two communities. II. Using a Community-Based Participatory Research (CBPR) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in African Americans. III. Examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence African Americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking. IV. Examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (CRC) screening and health care seeking behaviors. OUTLINE: Program locations are randomized to 1 of 2 arms. ARM I: Participants view videos with information about CRC and screening delivered by personal narrative. ARM II: Participants view videos with information about CRC and screening delivered by informative fact-based message. After completion of study, patients are followed up at 3 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1310
• Est. completion date: September 23, 2017
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
• EDUCATIONAL INTERVENTION:
• Currently non-adherent to colorectal cancer screening
• Self-identify as African American
• Are 50 years of age or older
• Have the ability to provide informed consent in English
• FOLLOW-UP ASSESSMENTS:
• Must be non-adherent for CRC screening at the time of the educational program
• Have telephone service (mobile or landline), to participate in the follow up interviews
• Agree to providing consent for release/review of their medical record

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Healthy, no Evidence of Disease

Intervention

Behavioral:
• behavioral intervention
View personal narrative informational video
• behavioral intervention
View fact-based informational video

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in likelihood of CRC screening in previously unscreened subjects	A change score (post-presentation minus pre-presentation) will be created and summarized. In addition, the change score will be further dichotomized (e.g. increase versus no increase in the likelihood of screening) and the percent of those who experienced an increased likelihood, denoted by pi, will be computed. A corresponding 95% confidence interval will be calculated. To test for differences in variables collected pre- and post-presentation, generalized mixed linear models will be used. Testing will be done at the 0.0.5 nominal significance level and using the approximate t-test method.	Baseline to 6 months post-presentation
Secondary	Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys	A linear mixed model (LMM) will be employed and implemented in the SAS program MIXED.	Post-presentation up to 6 months
Secondary	Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey	An LMM will be employed and implemented in the SAS program MIXED.	Post-presentation up to 6 months
Secondary	Number of participants who had or scheduled colonoscopy	A generalized linear model with a logit link function will be used.	Up to 6 months
Secondary	Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)	A generalized linear model with a logit link function will be used.	Up to 6 months
Secondary	Number of participants who discussed CRC screening with their primary care physician	A generalized linear model with a logit link function will be used.	Up to 6 months
Secondary	Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences	Qualitative text from a text analysis program will be funneled into categories using the PEN-3 and analyzed according to the categories' role and influence. Findings will be examined in comparison to quantitative data regarding the content of the intervention.	Baseline to 1 week post-presentation & 6-months
Secondary	Influential factors in behavior changes, assessed using qualitative analyses of text from participant interviews, including affective associations with the program, participants' cognitive-affective influences, and predisposing influences	Qualitative text from a text analysis program will be funneled into categories using the PEN-3 and analyzed according to the categories' role and influence. Findings will be examined in comparison to quantitative data regarding the content of the intervention.	1 week post-presentation to 6 months