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Evaluating Strategies to Present Colon Cancer Screening Information

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ClinicalTrials.gov Identifier: NCT02485561
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amy McQueen, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 30, 2015
Results First Submitted Date  ICMJE May 2, 2018
Results First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE June 1, 2015
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Intentions to Get Screened for Colon Cancer [ Time Frame: Immediately post-intervention ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
Intentions to get screened for colon cancer in the next 6 months will be assessed with a visual analog response scale. [ Time Frame: Immediately post-intervention ]
Mean group differences will be examined.
Change History Complete list of historical versions of study NCT02485561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Identification With the Character [ Time Frame: Immediately post-intervention ]
    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 [ Time Frame: Immediately post-intervention ]
    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 [ Time Frame: Immediately post-intervention ]
    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 [ Time Frame: Immediately post-intervention ]
    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 [ Time Frame: Immediately post-intervention ]
    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 [ Time Frame: Immediately post-intervention ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Identification with the character will be assessed with perceived similarity and liking (3 items each) based on previous work by the study investigators. (McQueen & Kreuter 2010; McQueen et al., 2011) [ Time Frame: Immediately post-intervention ]
    Means will be compared between the two groups assigned to read a narrative.
  • Engagement will be assessed with an 8-item version of the Transportation Scale. (Sestir, 2010; Green & Brock, 2000) [ Time Frame: Immediately post-intervention ]
    Means will be compared between relevant groups: all three groups can be compared on 5 general items about the assigned readings. Participants in the narrative conditions can be further compared on the 3 items that assess empathy and vivid mental images of the person in the story.
  • Self-efficacy for getting screened for colon cancer will be assessed with a previously validated multi-item scale.(McQueen et al., 2008) [ Time Frame: Immediately post-intervention ]
    Items assess confidence in getting screened for colon cancer despite common barriers. Response options range from 1=not at all confident to 7=very confident. Means will be compared between all three study groups.
  • Affect: Items from the Positive and Negative Affect Schedule (PANAS; Crawford & Henry 2004) will measure affective responses while reading the colon cancer and screening materials. [ Time Frame: Immediately post-intervention ]
    Means will be compared between all three study groups.
  • Seven scales assessing defensive information processing will be assessed using previously validated measures.(McQueen et al., 2013, McQueen et al., 2014) [ Time Frame: Immediately post-intervention ]
    Response options range from 1=strongly disagree to 7=strongly agree. Means will be compared between all three study groups.
  • Perceived susceptibility to colon cancer will be assessed with multiple standard items assessing absolute, comparative, and feelings-of-risk of developing colon cancer. (Weinstein 2007) [ Time Frame: Immediately post-intervention ]
    Response options range from 1=strongly disagree to 5=strongly agree. Mean scores will be compared between all three study groups.
  • Perceived prevalence of finding colon cancer during screening will be assessed with three items developed for this study. [ Time Frame: Immediately post-intervention ]
    Response options range from 1=strongly disagree to 7=strongly agree. Means will be compared between all three study groups.
Current Other Pre-specified Outcome Measures
 (submitted: October 18, 2018)
  • Social Influence [ Time Frame: Immediately post-intervention ]
    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.
  • Worry [ Time Frame: Immediately post-intervention ]
    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.
  • Perceived Benefits and Barriers of Colorectal Cancer Screening [ Time Frame: Immediately post-intervention ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: June 25, 2015)
  • 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. [ Time Frame: Immediately post-intervention ]
    Response options range from 1=strongly disagree to 7=strongly agree. Means will be compared between all three study groups.
  • Multiple items will assess worry for developing and detecting colon cancer, and worry about the test procedure itself based on items from previous work. [ Time Frame: Immediately post-intervention ]
    Means will be compared between all three study groups.
  • Perceived benefits and barriers of colorectal cancer screening will be assessed with previously validated scales. (McQueen 2008) [ Time Frame: Immediately post-intervention ]
    Response options range from 1=strongly disagree to 7=strongly agree. Means will be compared between all three study groups.
  • Steps to completing screening will be measured by items created for this study including: seeking information, talking to others, having an appointment or home test kit, doing any prep, and completing a test. [ Time Frame: 1 month follow up ]
    Individual steps and a sum index will be compared between all three study groups.
 
Descriptive Information
Brief Title  ICMJE Evaluating Strategies to Present Colon Cancer Screening Information
Official Title  ICMJE Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Colonic Diseases
  • Gastrointestinal Neoplasms
Intervention  ICMJE
  • Behavioral: Health communication intervention
    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.
  • Behavioral: Education information
    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.
Study Arms  ICMJE
  • Active Comparator: Information only
    INTERVENTION: Information about colon cancer and screening tests from sources such as the Centers for Disease Control and Prevention Screen for Life campaign.
    Intervention: Behavioral: Education information
  • Experimental: Screener Narrative
    INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer
    Interventions:
    • Behavioral: Health communication intervention
    • Behavioral: Education information
  • Experimental: Survivor Narrative
    INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer
    Interventions:
    • Behavioral: Health communication intervention
    • Behavioral: Education information
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
486
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2015)
400
Actual Study Completion Date  ICMJE January 31, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02485561
Other Study ID Numbers  ICMJE HRPO201501019
R21CA187608 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: A data sharing agreement with an interested researcher that complies with federal, university, and institution review board standards for protecting data.
Responsible Party Amy McQueen, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Amy McQueen, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP