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Trial record 4 of 3909 for:    colon cancer AND Colonic Diseases

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

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

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Colorectal Neoplasms Colonic Diseases Gastrointestinal Neoplasms Behavioral: Health communication intervention Behavioral: Education information Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Arm Intervention/treatment
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.
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.

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485561


Locations
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United States, Missouri
Washington University website HeathStudy.wustl.edu
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amy McQueen, PhD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Amy McQueen, Washington University School of Medicine:
Informed Consent Form  [PDF] December 3, 2015


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

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Responsible Party: Amy McQueen, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02485561     History of Changes
Other Study ID Numbers: HRPO201501019
R21CA187608 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2015    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy McQueen, Washington University School of Medicine:
Colon cancer screening
Colorectal cancer screening
Colonoscopy
Sigmoidoscopy
Stool blood test
Narrative

Additional relevant MeSH terms:
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Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Intestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases