Clinical trial NCT02100254: Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities
Official title: CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Healthy, no Evidence of Disease
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 1310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in likelihood of CRC screening in previously unscreened subjects
timeFrame: Baseline to 6 months post-presentation
Secondary outcomes:
measure: Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys
timeFrame: Post-presentation up to 6 months
measure: Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey
timeFrame: Post-presentation up to 6 months
measure: Number of participants who had or scheduled colonoscopy
timeFrame: Up to 6 months
measure: Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)
timeFrame: Up to 6 months
measure: Number of participants who discussed CRC screening with their primary care physician
timeFrame: Up to 6 months
measure: 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
timeFrame: Baseline to 1 week post-presentation & 6-months
measure: 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
timeFrame: 1 week post-presentation to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Deborah Erwin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiviniemi MT, Klasko-Foster LB, Erwin DO, Jandorf L. Decision-making and socioeconomic disparities in colonoscopy screening in African Americans. Health Psychol. 2018 May;37(5):481-490. doi: 10.1037/hea0000603. Epub 2018 Mar 29.