NCT02100254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,310

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2017

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

7 years

First QC Date

March 12, 2014

Last Update Submit

July 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 6 months post-presentation

Secondary Outcomes (7)

  • Number of negative affective responses to CRC screening per Affective Associations and Affectively-Based Risk surveys

    Post-presentation up to 6 months

  • Number of positive cognitive responses to CRC screening per Cognitively-Based Perceived Risk survey

    Post-presentation up to 6 months

  • Number of participants who had or scheduled colonoscopy

    Up to 6 months

  • Number of participants who performed the fecal occult blood test (FOBT)/fecal immunohistochemistry test (FIT)

    Up to 6 months

  • Number of participants who discussed CRC screening with their primary care physician

    Up to 6 months

  • +2 more secondary outcomes

Study Arms (2)

Arm I (personal narrative)

EXPERIMENTAL

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

Behavioral: behavioral intervention

Arm II (fact-based message)

ACTIVE COMPARATOR

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

Behavioral: behavioral intervention

Interventions

View personal narrative informational video

Also known as: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Arm I (personal narrative)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Deborah Erwin

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 31, 2014

Study Start

October 1, 2009

Primary Completion

September 23, 2016

Study Completion

September 23, 2017

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations