Clinical trial NCT02485561: Evaluating Strategies to Present Colon Cancer Screening Information
Official title: Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Colorectal Neoplasms
Colonic Diseases
Gastrointestinal Neoplasms
Keywords: Colon cancer screening
Colorectal cancer screening
Colonoscopy
Sigmoidoscopy
Stool blood test
Narrative
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-06-30
Enrollment: 486
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: The use of patient narratives in interventions and their availability on the Internet is becoming ubiquitous and has far outpaced empirical research to assess how and for whom narratives are effective. To improve future behavioral interventions that incorporate narratives, researchers need to identify the best role models to promote colon cancer screening and examine their potentially different mechanisms of influence.

For the proposed web-based, 3-arm English-language pilot intervention with a brief, 1 month follow-up, the study investigators will randomize 400 average-risk adults age 50-75 who are non-adherent to colon cancer screening guidelines and have no cancer history to one of three groups to read: 1) basic information about colon cancer risk and test options, 2) the same colon cancer and screening information plus a narrative from a colon cancer survivor, or 3) the same colon cancer and screening information plus a narrative from someone who got screened for colon cancer. To better assess behavior change, a 6 and 12 month follow up survey was added.

All participants will read general information about colon cancer and screening guidelines, test options, and benefits based on Centers for Disease Control and Prevention educational materials. Narrative participants will then view a role model that is tailored to each participant by gender, race/ ethnicity, and age group. Along with a photo will be a brief message to identify role models as colon cancer survivors or screeners. Narrative conditions will include a single role model and story of first-person experiences of colonoscopy. Participants will complete survey measures before and after the information and stories are presented and at one, 6, and 12 month follow-up. Participation in the first part of the study will take about 30 minutes and about 15 minutes for the follow up survey. Participants can complete all study requirements through our website: http://HealthStudy.wustl.edu

This study will examine potential mediators or mechanisms that explain the effects of these narratives on screening-related outcomes based on a proposed conceptual model. The study investigators will enroll a diverse sample of participants to explore any differences in narrative effects by audience characteristics (potential moderators).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intentions to Get Screened for Colon Cancer
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Identification With the Character
timeFrame: Immediately post-intervention
measure: Three Measures of Engagement
timeFrame: Immediately post-intervention
measure: Self-efficacy for Getting Screened for Colon Cancer
timeFrame: Immediately post-intervention
measure: Affect
timeFrame: Immediately post-intervention
measure: Defensive Information Processing
timeFrame: Immediately post-intervention
measure: Absolute Perceived Susceptibility to Colon Cancer
timeFrame: Immediately post-intervention
Other outcomes:
measure: Social Influence
timeFrame: Immediately post-intervention
measure: Worry
timeFrame: Immediately post-intervention
measure: Perceived Benefits and Barriers of Colorectal Cancer Screening
timeFrame: Immediately post-intervention
Locations:
city: Saint Louis
country: United States
facility: Washington University website HeathStudy.wustl.edu
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amy McQueen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sestir M, Green MC. You are who you watch: Identification and transportation effects on temporary self-concept. Social Influence 5(4): 272-88, 2010.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.