- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100254
Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities
CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
New York, New York, United States, 10029
- Mount Sinai School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (personal narrative)
Participants view videos with information about CRC and screening delivered by personal narrative.
|
View personal narrative informational video
Other Names:
View fact-based informational video
Other Names:
|
Active Comparator: Arm II (fact-based message)
Participants view videos with information about CRC and screening delivered by informative fact-based message.
|
View personal narrative informational video
Other Names:
View fact-based informational video
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in likelihood of CRC screening in previously unscreened subjects
Time Frame: Baseline to 6 months post-presentation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys
Time Frame: Post-presentation up to 6 months
|
A linear mixed model (LMM) will be employed and implemented in the SAS program MIXED.
|
Post-presentation up to 6 months
|
Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey
Time Frame: Post-presentation up to 6 months
|
An LMM will be employed and implemented in the SAS program MIXED.
|
Post-presentation up to 6 months
|
Number of participants who had or scheduled colonoscopy
Time Frame: Up to 6 months
|
A generalized linear model with a logit link function will be used.
|
Up to 6 months
|
Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)
Time Frame: Up to 6 months
|
A generalized linear model with a logit link function will be used.
|
Up to 6 months
|
Number of participants who discussed CRC screening with their primary care physician
Time Frame: Up to 6 months
|
A generalized linear model with a logit link function will be used.
|
Up to 6 months
|
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
Time Frame: Baseline to 1 week post-presentation & 6-months
|
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
|
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
Time Frame: 1 week post-presentation to 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deborah Erwin, Roswell Park Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 159309 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2013-01707 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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