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

Primary Purpose

Colorectal Cancer, Healthy, no Evidence of Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavioral intervention
behavioral intervention
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute
  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (personal narrative)

Arm II (fact-based message)

Arm Description

Participants view videos with information about CRC and screening delivered by personal narrative.

Participants view videos with information about CRC and screening delivered by informative fact-based message.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of participants who had or scheduled colonoscopy
A generalized linear model with a logit link function will be used.
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.
Number of participants who discussed CRC screening with their primary care physician
A generalized linear model with a logit link function will be used.
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.
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.

Full Information

First Posted
March 12, 2014
Last Updated
July 20, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02100254
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (undefined)
Primary Completion Date
September 23, 2016 (Actual)
Study Completion Date
September 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Healthy, no Evidence of Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (personal narrative)
Arm Type
Experimental
Arm Description
Participants view videos with information about CRC and screening delivered by personal narrative.
Arm Title
Arm II (fact-based message)
Arm Type
Active Comparator
Arm Description
Participants view videos with information about CRC and screening delivered by informative fact-based message.
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Intervention Description
View personal narrative informational video
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Intervention Description
View fact-based informational video
Primary Outcome Measure Information:
Title
Change in likelihood of CRC screening in previously unscreened subjects
Description
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.
Time Frame
Baseline to 6 months post-presentation
Secondary Outcome Measure Information:
Title
Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys
Description
A linear mixed model (LMM) will be employed and implemented in the SAS program MIXED.
Time Frame
Post-presentation up to 6 months
Title
Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey
Description
An LMM will be employed and implemented in the SAS program MIXED.
Time Frame
Post-presentation up to 6 months
Title
Number of participants who had or scheduled colonoscopy
Description
A generalized linear model with a logit link function will be used.
Time Frame
Up to 6 months
Title
Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)
Description
A generalized linear model with a logit link function will be used.
Time Frame
Up to 6 months
Title
Number of participants who discussed CRC screening with their primary care physician
Description
A generalized linear model with a logit link function will be used.
Time Frame
Up to 6 months
Title
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
Description
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.
Time Frame
Baseline to 1 week post-presentation & 6-months
Title
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
Description
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.
Time Frame
1 week post-presentation to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Erwin
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29595298
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.
Results Reference
derived

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

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