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Evaluating Strategies to Present Colon Cancer Screening Information

Primary Purpose

Colonic Neoplasms, Colorectal Neoplasms, Colonic Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health communication intervention
Education information
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Neoplasms focused on measuring Colon cancer screening, Colorectal cancer screening, Colonoscopy, Sigmoidoscopy, Stool blood test, Narrative

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington University website HeathStudy.wustl.edu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Information only

Screener Narrative

Survivor Narrative

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Identification With the Character
Participants assigned to narrative conditions were asked if they liked and felt similar to the character in the story they read with 3 items each with response options 1=Strongly Disagree - 5=Strongly Agree. Measures were based on previous work by the study investigators. Mean scores for liking and similarity were created; higher scores reflect higher perceived similarity and liking for the character. Means will be compared between the two groups assigned to read a narrative.
Three Measures of Engagement
Confirmatory factor analyses did not support an aggregate measure adapted from an existing transportation scale, so a single item "What I just read affected me emotionally" was used to measure emotional engagement for all participants. For participants assigned to either narrative condition, two items reflected cognitive (imagery) engagement "While I was reading the story, I could easily picture the events in it taking place" and "I had a vivid mental image of the person in the story". Mean scores were created for cognitive engagement. Two items reflected self-referencing engagement: "I could picture myself in the scene of the events described in the story" and "The events in the story are relevant to my life" were assessed and mean scores created for self-referencing engagement. Responses for all items were 1=Not at all - 7=Very much. Higher mean scores reflected higher engagement.
Self-efficacy for Getting Screened for Colon Cancer
Six items assess confidence in getting screened for colon cancer despite common barriers. Mean scores are created from response options that range from 1=not at all confident to 7=very confident. Higher scores reflect greater confidence in getting colorectal cancer screening. Means will be compared between all three study groups.
Affect
Using the Positive and Negative Affect Schedule, we assessed the strength of 5 positive (happy, proud, strong, inspired, hopeful) and 5 negative (angry, guilty, sad, nervous, afraid) emotions felt during the assigned reading (1=Not at all - 7=Extremely). Higher mean subscale scores reflect stronger positive and negative emotions. Means will be compared between all three study groups.
Defensive Information Processing
Seven scales assessing defensive information processing will be assessed using previously validated measures for opt-out behavior (3 items), opt-out information (1 item), blunting (2 items), self-exemption (5 items), deny immediacy (3 items), counterarguing (4 items), and minimize the harm (2 items). Response options range from 1=strongly disagree to 7=strongly agree. Mean scores are created for each scale and higher scores reflect greater defensive information processing. Means will be compared between all three study groups.
Absolute Perceived Susceptibility to Colon Cancer
Absolute perceived risk was assessed with three items: I am at risk for developing colorectal cancer, If I do not get screened regularly, I would feel vulnerable to developing colorectal cancer, If I do not get screened regularly, it is likely that I will develop colorectal cancer. Response options range from 1=strongly disagree to 5=strongly agree. Mean scale scores were created and higher scores reflect greater perceived susceptibility to colorectal cancer. Mean scores will be compared between all three study groups.

Full Information

First Posted
June 18, 2015
Last Updated
October 18, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02485561
Brief Title
Evaluating Strategies to Present Colon Cancer Screening Information
Official Title
Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Colorectal Neoplasms, Colonic Diseases, Gastrointestinal Neoplasms
Keywords
Colon cancer screening, Colorectal cancer screening, Colonoscopy, Sigmoidoscopy, Stool blood test, Narrative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
486 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information only
Arm Type
Active Comparator
Arm Description
INTERVENTION: Information about colon cancer and screening tests from sources such as the Centers for Disease Control and Prevention Screen for Life campaign.
Arm Title
Screener Narrative
Arm Type
Experimental
Arm Description
INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer
Arm Title
Survivor Narrative
Arm Type
Experimental
Arm Description
INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer
Intervention Type
Behavioral
Intervention Name(s)
Health communication intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intentions to Get Screened for Colon Cancer
Description
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.
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Identification With the Character
Description
Participants assigned to narrative conditions were asked if they liked and felt similar to the character in the story they read with 3 items each with response options 1=Strongly Disagree - 5=Strongly Agree. Measures were based on previous work by the study investigators. Mean scores for liking and similarity were created; higher scores reflect higher perceived similarity and liking for the character. Means will be compared between the two groups assigned to read a narrative.
Time Frame
Immediately post-intervention
Title
Three Measures of Engagement
Description
Confirmatory factor analyses did not support an aggregate measure adapted from an existing transportation scale, so a single item "What I just read affected me emotionally" was used to measure emotional engagement for all participants. For participants assigned to either narrative condition, two items reflected cognitive (imagery) engagement "While I was reading the story, I could easily picture the events in it taking place" and "I had a vivid mental image of the person in the story". Mean scores were created for cognitive engagement. Two items reflected self-referencing engagement: "I could picture myself in the scene of the events described in the story" and "The events in the story are relevant to my life" were assessed and mean scores created for self-referencing engagement. Responses for all items were 1=Not at all - 7=Very much. Higher mean scores reflected higher engagement.
Time Frame
Immediately post-intervention
Title
Self-efficacy for Getting Screened for Colon Cancer
Description
Six items assess confidence in getting screened for colon cancer despite common barriers. Mean scores are created from response options that range from 1=not at all confident to 7=very confident. Higher scores reflect greater confidence in getting colorectal cancer screening. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention
Title
Affect
Description
Using the Positive and Negative Affect Schedule, we assessed the strength of 5 positive (happy, proud, strong, inspired, hopeful) and 5 negative (angry, guilty, sad, nervous, afraid) emotions felt during the assigned reading (1=Not at all - 7=Extremely). Higher mean subscale scores reflect stronger positive and negative emotions. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention
Title
Defensive Information Processing
Description
Seven scales assessing defensive information processing will be assessed using previously validated measures for opt-out behavior (3 items), opt-out information (1 item), blunting (2 items), self-exemption (5 items), deny immediacy (3 items), counterarguing (4 items), and minimize the harm (2 items). Response options range from 1=strongly disagree to 7=strongly agree. Mean scores are created for each scale and higher scores reflect greater defensive information processing. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention
Title
Absolute Perceived Susceptibility to Colon Cancer
Description
Absolute perceived risk was assessed with three items: I am at risk for developing colorectal cancer, If I do not get screened regularly, I would feel vulnerable to developing colorectal cancer, If I do not get screened regularly, it is likely that I will develop colorectal cancer. Response options range from 1=strongly disagree to 5=strongly agree. Mean scale scores were created and higher scores reflect greater perceived susceptibility to colorectal cancer. Mean scores will be compared between all three study groups.
Time Frame
Immediately post-intervention
Other Pre-specified Outcome Measures:
Title
Social Influence
Description
Social influence will be assessed with three items developed for this study based on standard measures that include physician, family, and friends as important social referents encouraging colorectal cancer screening. Response options range from 1=strongly disagree to 7=strongly agree. Mean scores were created and higher scores reflect greater perceived social influence for getting screened for colorectal cancer. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention
Title
Worry
Description
Worry was assessed with four items regarding worry about getting colorectal cancer, having a test that shows they have colorectal cancer, concern that colorectal cancer screening will be physically uncomfortable, and concern that there could be complications from the test. Response options ranged from 1=strongly disagree to 5=strongly agree. Mean scores were created (Range 1-5); higher scores reflect greater worry. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention
Title
Perceived Benefits and Barriers of Colorectal Cancer Screening
Description
Perceived colorectal cancer screening benefits (8 items) barriers (6 items) are assessed with items from previously validated scales. Response options range from 1=strongly disagree to 7=strongly agree. Mean scores were created for each scale; higher scores reflect greater perceived benefits and barriers of getting screened. Means will be compared between all three study groups.
Time Frame
Immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McQueen, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University website HeathStudy.wustl.edu
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
A data sharing agreement with an interested researcher that complies with federal, university, and institution review board standards for protecting data.
Citations:
PubMed Identifier
17385965
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.
Results Reference
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Results Reference
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15333231
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.
Results Reference
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PubMed Identifier
11079236
Citation
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Results Reference
background
PubMed Identifier
21895370
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.
Results Reference
background
PubMed Identifier
20850258
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.
Results Reference
background
PubMed Identifier
22353026
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.
Results Reference
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PubMed Identifier
23864072
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.
Results Reference
background
PubMed Identifier
18768488
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.
Results Reference
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Citation
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Results Reference
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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.
Results Reference
derived

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Evaluating Strategies to Present Colon Cancer Screening Information

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