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

July 20, 2022 updated by: Roswell Park Cancer Institute

CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans

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.

Study Overview

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

Interventional

Enrollment (Actual)

1310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
View fact-based informational video
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
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:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
View fact-based informational video
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deborah Erwin, Roswell Park Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 23, 2016

Study Completion (Actual)

September 23, 2017

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

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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