NCT02485561

Brief Summary

This is a study examining the effects of different educational-motivational materials about colorectal cancer screening on perceptions and intentions to get screened. Eligible participants will be randomized to one of three experimental conditions. All participants will be provided information about colon cancer and screening options based on the Centers for Disease Control and Prevention Screen for Life materials. Some participants also will be asked to read a personal narrative about colon cancer screening. This study will determine whether participant's perceptions about and colorectal cancer screening intentions and behaviors differ by which information they read. Participants will complete surveys before, immediately after, and one month after randomization. To assess behavior change, as suggested by grant reviewers and the project officer, we added 6 and 12 month follow up surveys. Participants can complete all study requirements through the study website: http://HealthStudy.wustl.edu

Trial Health

87
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

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

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

June 18, 2015

Results QC Date

May 2, 2018

Last Update Submit

October 18, 2018

Conditions

Colonic NeoplasmsColorectal NeoplasmsColonic DiseasesGastrointestinal Neoplasms

Keywords

Colon cancer screeningColorectal cancer screeningColonoscopySigmoidoscopyStool blood testNarrative

Outcome Measures

Primary Outcomes (1)

  • Intentions to Get Screened for Colon Cancer

    Intention was measured on all surveys with the mean of 3 items assessed using slider bars (coded 1=not at all - 100=extremely) asking about the likelihood of being screened in the next 6 months, the importance of screening, and commitment to screening. Higher scores indicate greater intentions to get screened for colorectal cancer.

    Immediately post-intervention

Secondary Outcomes (6)

  • Identification With the Character

    Immediately post-intervention

  • Three Measures of Engagement

    Immediately post-intervention

  • Self-efficacy for Getting Screened for Colon Cancer

    Immediately post-intervention

  • Affect

    Immediately post-intervention

  • Defensive Information Processing

    Immediately post-intervention

  • +1 more secondary outcomes

Other Outcomes (3)

  • Social Influence

    Immediately post-intervention

  • Worry

    Immediately post-intervention

  • Perceived Benefits and Barriers of Colorectal Cancer Screening

    Immediately post-intervention

Study Arms (3)

Information only

ACTIVE COMPARATOR

INTERVENTION: Information about colon cancer and screening tests from sources such as the Centers for Disease Control and Prevention Screen for Life campaign.

Behavioral: Education information

Screener Narrative

EXPERIMENTAL

INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer

Behavioral: Health communication interventionBehavioral: Education information

Survivor Narrative

EXPERIMENTAL

INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer

Behavioral: Health communication interventionBehavioral: Education information

Interventions

Health communication interventionBEHAVIORAL

This study will compare the effects of adding narratives that describe personal experiences with colon cancer screening to educational information alone to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.

Screener NarrativeSurvivor Narrative
Education informationBEHAVIORAL

Educational materials such as those from the Centers for Disease Control and Prevention are used to present educational information to participants about colon cancer and screening tests.

Information onlyScreener NarrativeSurvivor Narrative

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female adults of any race or ethnicity living in the United States
  • Age 50-75 years old
  • Access to the Internet to complete all study requirements at http://HealthStudy.wustl.edu

You may not qualify if:

  • Unable to read English
  • Prior diagnosis of cancer (except non-melanoma skin cancer)
  • Prior diagnosis of Crohn's disease, inflammatory bowel disease or colitis
  • Currently adherent to colon cancer screening guidelines defined as a home-based stool blood test in the past 12 months, a sigmoidoscopy in the past 5 years, or a colonoscopy in the past 10 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University website HeathStudy.wustl.edu

St Louis, Missouri, 63110, United States

Location

Related Publications (12)

  • Weinstein ND, Kwitel A, McCaul KD, Magnan RE, Gerrard M, Gibbons FX. Risk perceptions: assessment and relationship to influenza vaccination. Health Psychol. 2007 Mar;26(2):146-51. doi: 10.1037/0278-6133.26.2.146.

    PMID: 17385965BACKGROUND

  • Sestir M, Green MC. You are who you watch: Identification and transportation effects on temporary self-concept. Social Influence 5(4): 272-88, 2010.

    BACKGROUND

  • Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.

    PMID: 15333231BACKGROUND

  • Green MC, Brock TC. The role of transportation in the persuasiveness of public narratives. J Pers Soc Psychol. 2000 Nov;79(5):701-21. doi: 10.1037//0022-3514.79.5.701.

    PMID: 11079236BACKGROUND

  • McQueen A, Kreuter MW, Kalesan B, Alcaraz KI. Understanding narrative effects: the impact of breast cancer survivor stories on message processing, attitudes, and beliefs among African American women. Health Psychol. 2011 Nov;30(6):674-82. doi: 10.1037/a0025395. Epub 2011 Sep 5.

    PMID: 21895370BACKGROUND

  • McQueen A, Kreuter MW. Women's cognitive and affective reactions to breast cancer survivor stories: a structural equation analysis. Patient Educ Couns. 2010 Dec;81 Suppl:S15-21. doi: 10.1016/j.pec.2010.08.015. Epub 2010 Sep 17.

    PMID: 20850258BACKGROUND

  • McQueen A, Vernon SW, Swank PR. Construct definition and scale development for defensive information processing: an application to colorectal cancer screening. Health Psychol. 2013 Feb;32(2):190-202. doi: 10.1037/a0027311. Epub 2012 Feb 20.

    PMID: 22353026BACKGROUND

  • McQueen A, Swank PR, Vernon SW. Examining patterns of association with defensive information processing about colorectal cancer screening. J Health Psychol. 2014 Nov;19(11):1443-58. doi: 10.1177/1359105313493649. Epub 2013 Jul 17.

    PMID: 23864072BACKGROUND

  • McQueen A, Tiro JA, Vernon SW. Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening. Cancer Epidemiol Biomarkers Prev. 2008 Sep;17(9):2231-7. doi: 10.1158/1055-9965.EPI-08-0176.

    PMID: 18768488BACKGROUND

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND

  • Vernon SW, Meissner H, Klabunde C, Rimer BK, Ahnen DJ, Bastani R, Mandelson MT, Nadel MR, Sheinfeld-Gorin S, Zapka J. Measures for ascertaining use of colorectal cancer screening in behavioral, health services, and epidemiologic research. Cancer Epidemiol Biomarkers Prev. 2004 Jun;13(6):898-905. No abstract available.

    PMID: 15184243BACKGROUND

  • McQueen A, Caburnay C, Kreuter M, Sefko J. Improving Adherence to Colorectal Cancer Screening: A Randomized Intervention to Compare Screener vs. Survivor Narratives. J Health Commun. 2019;24(2):141-155. doi: 10.1080/10810730.2019.1587109. Epub 2019 Mar 29.

    PMID: 30924402DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsColonic DiseasesGastrointestinal NeoplasmsNarration

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesCommunicationBehavior

Results Point of Contact

Title
Amy McQueen
Organization
Washington University in St. Louis
amcqueen@wustl.edu
3142862016

Study Officials

  • Amy McQueen, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 30, 2015

Study Start

June 1, 2015

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

November 15, 2018

Results First Posted

November 15, 2018

Record last verified: 2018-10

Locations

US(1)