Colonic Diseases, Colonic Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms
Conditions
Keywords
Colon cancer screening, Colorectal cancer screening, Colonoscopy, Sigmoidoscopy, Stool blood test, Narrative
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).
Interventions
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.
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intentions to Get Screened for Colon Cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Getting Screened for Colon Cancer | 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 | 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 | 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 | 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. |
| Identification With the Character | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Benefits and Barriers of Colorectal Cancer Screening | 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. |
| Social Influence | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
We sent electronic invitations to prospective participants from two opt-in registries: 1) Washington University's Volunteer for Health Research Participant Registry and 2) ResearchMatch.org hosted by Vanderbilt University.
Pre-assignment details
Nearly all participants completed all study components online. They provided informed consent and proceeded to the baseline survey (n=486). Only those that completed the baseline survey were randomized (n=477) to one of three intervention conditions, so that number is smaller than the total who started the study.
Participants by arm
| Arm | Count |
|---|---|
| Information Only INTERVENTION: Information about colon cancer and screening tests.
Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 161 |
| Screener Narrative INTERVENTION: Information + Personal Narrative from someone who was screened for colon cancer
Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.
Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 157 |
| Survivor Narrative INTERVENTION: Information + Personal Narrative from someone who was screened for, and diagnosed with, colon cancer
Health communication intervention: This study will compare the effects of adding personal experiences with colon cancer screening to educational information to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.
Education information: Typical materials are used to present educational information to participants about colon cancer and screening tests. | 159 |
| Total | 477 |
Baseline characteristics
| Characteristic | Information Only | Screener Narrative | Survivor Narrative | Total |
|---|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 5.8 | 57.8 years STANDARD_DEVIATION 6.6 | 57.4 years STANDARD_DEVIATION 6.2 | 57.4 years STANDARD_DEVIATION 6.2 |
| Any prior colorectal cancer screening | 45 Participants | 57 Participants | 51 Participants | 153 Participants |
| Race/Ethnicity, Customized African American/Black | 28 Participants | 24 Participants | 25 Participants | 77 Participants |
| Race/Ethnicity, Customized Caucasian/White | 123 Participants | 126 Participants | 128 Participants | 377 Participants |
| Race/Ethnicity, Customized Other race | 10 Participants | 7 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Female | 109 Participants | 108 Participants | 117 Participants | 334 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 42 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 155 | 0 / 159 |
| other Total, other adverse events | 0 / 159 | 0 / 155 | 0 / 159 |
| serious Total, serious adverse events | 0 / 159 | 0 / 155 | 0 / 159 |
Outcome results
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.
Time frame: Immediately post-intervention
Population: Participants who completed the baseline, intervention, and immediately post-intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information Only | Intentions to Get Screened for Colon Cancer | 68.64 units on a 0-100 scale | Standard Deviation 26.42 |
| Screener Narrative | Intentions to Get Screened for Colon Cancer | 65.51 units on a 0-100 scale | Standard Deviation 27.29 |
| Survivor Narrative | Intentions to Get Screened for Colon Cancer | 64.30 units on a 0-100 scale | Standard Deviation 29.99 |
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.
Time frame: Immediately post-intervention
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information Only | Absolute Perceived Susceptibility to Colon Cancer | 2.98 units on a 5-point response scale | Standard Deviation 0.76 |
| Screener Narrative | Absolute Perceived Susceptibility to Colon Cancer | 3.03 units on a 5-point response scale | Standard Deviation 0.72 |
| Survivor Narrative | Absolute Perceived Susceptibility to Colon Cancer | 3.08 units on a 5-point response scale | Standard Deviation 0.78 |
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.
Time frame: Immediately post-intervention
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Information Only | Affect | Positive affect | 2.88 units on a 7-point response scale | Standard Deviation 1.58 |
| Information Only | Affect | Negative affect | 2.45 units on a 7-point response scale | Standard Deviation 1.34 |
| Screener Narrative | Affect | Positive affect | 3.22 units on a 7-point response scale | Standard Deviation 1.57 |
| Screener Narrative | Affect | Negative affect | 2.07 units on a 7-point response scale | Standard Deviation 1.1 |
| Survivor Narrative | Affect | Negative affect | 2.91 units on a 7-point response scale | Standard Deviation 1.41 |
| Survivor Narrative | Affect | Positive affect | 3.09 units on a 7-point response scale | Standard Deviation 1.47 |
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.
Time frame: Immediately post-intervention
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Information Only | Defensive Information Processing | Blunting | 3.75 units on a 7-point response scale | Standard Deviation 1.79 |
| Information Only | Defensive Information Processing | Suppression | 2.97 units on a 7-point response scale | Standard Deviation 1.27 |
| Information Only | Defensive Information Processing | Self-exemption | 3.15 units on a 7-point response scale | Standard Deviation 1.75 |
| Information Only | Defensive Information Processing | Opt-out behavior | 3.72 units on a 7-point response scale | Standard Deviation 1.75 |
| Information Only | Defensive Information Processing | Opt-out information | 2.79 units on a 7-point response scale | Standard Deviation 1.85 |
| Information Only | Defensive Information Processing | Normalize the risk | 2.89 units on a 7-point response scale | Standard Deviation 1.39 |
| Information Only | Defensive Information Processing | Counterarguing | 2.17 units on a 7-point response scale | Standard Deviation 1.13 |
| Screener Narrative | Defensive Information Processing | Self-exemption | 3.30 units on a 7-point response scale | Standard Deviation 1.83 |
| Screener Narrative | Defensive Information Processing | Opt-out behavior | 3.69 units on a 7-point response scale | Standard Deviation 1.82 |
| Screener Narrative | Defensive Information Processing | Opt-out information | 2.54 units on a 7-point response scale | Standard Deviation 1.68 |
| Screener Narrative | Defensive Information Processing | Blunting | 3.63 units on a 7-point response scale | Standard Deviation 1.68 |
| Screener Narrative | Defensive Information Processing | Suppression | 3.10 units on a 7-point response scale | Standard Deviation 1.33 |
| Screener Narrative | Defensive Information Processing | Counterarguing | 2.31 units on a 7-point response scale | Standard Deviation 1.26 |
| Screener Narrative | Defensive Information Processing | Normalize the risk | 2.87 units on a 7-point response scale | Standard Deviation 1.44 |
| Survivor Narrative | Defensive Information Processing | Suppression | 2.83 units on a 7-point response scale | Standard Deviation 1.23 |
| Survivor Narrative | Defensive Information Processing | Opt-out information | 2.90 units on a 7-point response scale | Standard Deviation 1.77 |
| Survivor Narrative | Defensive Information Processing | Normalize the risk | 3.05 units on a 7-point response scale | Standard Deviation 1.55 |
| Survivor Narrative | Defensive Information Processing | Counterarguing | 2.30 units on a 7-point response scale | Standard Deviation 1.36 |
| Survivor Narrative | Defensive Information Processing | Self-exemption | 3.06 units on a 7-point response scale | Standard Deviation 1.77 |
| Survivor Narrative | Defensive Information Processing | Blunting | 3.78 units on a 7-point response scale | Standard Deviation 1.76 |
| Survivor Narrative | Defensive Information Processing | Opt-out behavior | 3.68 units on a 7-point response scale | Standard Deviation 1.85 |
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.
Time frame: Immediately post-intervention
Population: Participants who completed baseline, intervention, and immediately post-intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Information Only | Identification With the Character | Perceived similarity | NA units on a 5-point response scale | — |
| Information Only | Identification With the Character | Liking of character | NA units on a 5-point response scale | — |
| Screener Narrative | Identification With the Character | Perceived similarity | 3.69 units on a 5-point response scale | Standard Deviation 0.81 |
| Screener Narrative | Identification With the Character | Liking of character | 3.73 units on a 5-point response scale | Standard Deviation 0.63 |
| Survivor Narrative | Identification With the Character | Perceived similarity | 3.47 units on a 5-point response scale | Standard Deviation 0.91 |
| Survivor Narrative | Identification With the Character | Liking of character | 3.75 units on a 5-point response scale | Standard Deviation 0.69 |
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.
Time frame: Immediately post-intervention
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information Only | Self-efficacy for Getting Screened for Colon Cancer | 5.80 units on a 7-point response scale | Standard Deviation 1.36 |
| Screener Narrative | Self-efficacy for Getting Screened for Colon Cancer | 5.81 units on a 7-point response scale | Standard Deviation 1.34 |
| Survivor Narrative | Self-efficacy for Getting Screened for Colon Cancer | 5.66 units on a 7-point response scale | Standard Deviation 1.33 |
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.
Time frame: Immediately post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Information Only | Three Measures of Engagement | Cognitive engagement | NA units on a scale | — |
| Information Only | Three Measures of Engagement | Emotional engagement | 2.95 units on a scale | Standard Deviation 1.86 |
| Information Only | Three Measures of Engagement | Self-referencing engagement | NA units on a scale | — |
| Screener Narrative | Three Measures of Engagement | Cognitive engagement | 5.45 units on a scale | Standard Deviation 1.35 |
| Screener Narrative | Three Measures of Engagement | Emotional engagement | 3.05 units on a scale | Standard Deviation 1.8 |
| Screener Narrative | Three Measures of Engagement | Self-referencing engagement | 5.23 units on a scale | Standard Deviation 1.47 |
| Survivor Narrative | Three Measures of Engagement | Emotional engagement | 3.65 units on a scale | Standard Deviation 1.94 |
| Survivor Narrative | Three Measures of Engagement | Self-referencing engagement | 4.51 units on a scale | Standard Deviation 1.73 |
| Survivor Narrative | Three Measures of Engagement | Cognitive engagement | 5.47 units on a scale | Standard Deviation 1.31 |
Perceived Benefits and Barriers of Colorectal Cancer Screening
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
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Information Only | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived benefits | 5.98 units on a scale | Standard Deviation 0.92 |
| Information Only | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived barriers | 3.15 units on a scale | Standard Deviation 1.34 |
| Screener Narrative | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived benefits | 6.08 units on a scale | Standard Deviation 0.93 |
| Screener Narrative | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived barriers | 3.15 units on a scale | Standard Deviation 1.29 |
| Survivor Narrative | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived benefits | 5.92 units on a scale | Standard Deviation 1 |
| Survivor Narrative | Perceived Benefits and Barriers of Colorectal Cancer Screening | Perceived barriers | 3.10 units on a scale | Standard Deviation 1.34 |
Social Influence
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
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information Only | Social Influence | 5.34 units on a scale | Standard Deviation 1.33 |
| Screener Narrative | Social Influence | 5.40 units on a scale | Standard Deviation 1.24 |
| Survivor Narrative | Social Influence | 5.32 units on a scale | Standard Deviation 1.19 |
Worry
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
Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Information Only | Worry | 2.62 units on a scale | Standard Deviation 0.99 |
| Screener Narrative | Worry | 2.66 units on a scale | Standard Deviation 0.82 |
| Survivor Narrative | Worry | 2.78 units on a scale | Standard Deviation 1.01 |