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Completed

NCT Number: NCT02100254

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Healthy, no Evidence of Disease Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute, Buffalo, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

View personal narrative informational video

Other names: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

CRC Screening Thoughts and Feelings: Increasing Engagement of African Americans

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
Mar 31, 2014
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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