Trial Outcomes & Findings for Evaluating Strategies to Present Colon Cancer Screening Information (NCT NCT02485561)

NCT ID: NCT02485561

Last Updated: 2018-11-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

486 participants

Primary outcome timeframe

Immediately post-intervention

Results posted on

2018-11-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
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.
Overall Study
STARTED
161
157
159
Overall Study
Completed 1 mo Survey
145
138
144
Overall Study
COMPLETED
133
118
136
Overall Study
NOT COMPLETED
28
39
23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Strategies to Present Colon Cancer Screening Information

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Information Only
n=161 Participants
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.
Screener Narrative
n=157 Participants
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.
Survivor Narrative
n=159 Participants
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.
Total
n=477 Participants
Total of all reporting groups
Age, Continuous
57.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
57.8 years
STANDARD_DEVIATION 6.6 • n=7 Participants
57.4 years
STANDARD_DEVIATION 6.2 • n=5 Participants
57.4 years
STANDARD_DEVIATION 6.2 • n=4 Participants
Sex: Female, Male
Female
109 Participants
n=5 Participants
108 Participants
n=7 Participants
117 Participants
n=5 Participants
334 Participants
n=4 Participants
Sex: Female, Male
Male
52 Participants
n=5 Participants
49 Participants
n=7 Participants
42 Participants
n=5 Participants
143 Participants
n=4 Participants
Race/Ethnicity, Customized
Caucasian/White
123 Participants
n=5 Participants
126 Participants
n=7 Participants
128 Participants
n=5 Participants
377 Participants
n=4 Participants
Race/Ethnicity, Customized
African American/Black
28 Participants
n=5 Participants
24 Participants
n=7 Participants
25 Participants
n=5 Participants
77 Participants
n=4 Participants
Race/Ethnicity, Customized
Other race
10 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
23 Participants
n=4 Participants
Any prior colorectal cancer screening
45 Participants
n=5 Participants
57 Participants
n=7 Participants
51 Participants
n=5 Participants
153 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline, intervention, and immediately post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Intentions to Get Screened for Colon Cancer
68.64 units on a 0-100 scale
Standard Deviation 26.42
65.51 units on a 0-100 scale
Standard Deviation 27.29
64.30 units on a 0-100 scale
Standard Deviation 29.99

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed baseline, intervention, and immediately post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Identification With the Character
Perceived similarity
NA units on a 5-point response scale
Standard Deviation NA
Info only participants did not get narratives thus did not have someone to compare themselves to
3.69 units on a 5-point response scale
Standard Deviation 0.81
3.47 units on a 5-point response scale
Standard Deviation 0.91
Identification With the Character
Liking of character
NA units on a 5-point response scale
Standard Deviation NA
Info only participants did not get narratives thus did not have someone to indicate their liking of
3.73 units on a 5-point response scale
Standard Deviation 0.63
3.75 units on a 5-point response scale
Standard Deviation 0.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Three Measures of Engagement
Emotional engagement
2.95 units on a scale
Standard Deviation 1.86
3.05 units on a scale
Standard Deviation 1.80
3.65 units on a scale
Standard Deviation 1.94
Three Measures of Engagement
Cognitive engagement
NA units on a scale
Standard Deviation NA
Info only participants were not exposed to a narrative so could not report on imagery from reading a story
5.45 units on a scale
Standard Deviation 1.35
5.47 units on a scale
Standard Deviation 1.31
Three Measures of Engagement
Self-referencing engagement
NA units on a scale
Standard Deviation NA
Info only participants were not exposed to a narrative so could not report on how the story relates to themselves
5.23 units on a scale
Standard Deviation 1.47
4.51 units on a scale
Standard Deviation 1.73

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Self-efficacy for Getting Screened for Colon Cancer
5.80 units on a 7-point response scale
Standard Deviation 1.36
5.81 units on a 7-point response scale
Standard Deviation 1.34
5.66 units on a 7-point response scale
Standard Deviation 1.33

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Affect
Positive affect
2.88 units on a 7-point response scale
Standard Deviation 1.58
3.22 units on a 7-point response scale
Standard Deviation 1.57
3.09 units on a 7-point response scale
Standard Deviation 1.47
Affect
Negative affect
2.45 units on a 7-point response scale
Standard Deviation 1.34
2.07 units on a 7-point response scale
Standard Deviation 1.10
2.91 units on a 7-point response scale
Standard Deviation 1.41

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Defensive Information Processing
Normalize the risk
2.89 units on a 7-point response scale
Standard Deviation 1.39
2.87 units on a 7-point response scale
Standard Deviation 1.44
3.05 units on a 7-point response scale
Standard Deviation 1.55
Defensive Information Processing
Opt-out information
2.79 units on a 7-point response scale
Standard Deviation 1.85
2.54 units on a 7-point response scale
Standard Deviation 1.68
2.90 units on a 7-point response scale
Standard Deviation 1.77
Defensive Information Processing
Opt-out behavior
3.72 units on a 7-point response scale
Standard Deviation 1.75
3.69 units on a 7-point response scale
Standard Deviation 1.82
3.68 units on a 7-point response scale
Standard Deviation 1.85
Defensive Information Processing
Blunting
3.75 units on a 7-point response scale
Standard Deviation 1.79
3.63 units on a 7-point response scale
Standard Deviation 1.68
3.78 units on a 7-point response scale
Standard Deviation 1.76
Defensive Information Processing
Self-exemption
3.15 units on a 7-point response scale
Standard Deviation 1.75
3.30 units on a 7-point response scale
Standard Deviation 1.83
3.06 units on a 7-point response scale
Standard Deviation 1.77
Defensive Information Processing
Suppression
2.97 units on a 7-point response scale
Standard Deviation 1.27
3.10 units on a 7-point response scale
Standard Deviation 1.33
2.83 units on a 7-point response scale
Standard Deviation 1.23
Defensive Information Processing
Counterarguing
2.17 units on a 7-point response scale
Standard Deviation 1.13
2.31 units on a 7-point response scale
Standard Deviation 1.26
2.30 units on a 7-point response scale
Standard Deviation 1.36

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Absolute Perceived Susceptibility to Colon Cancer
2.98 units on a 5-point response scale
Standard Deviation 0.76
3.03 units on a 5-point response scale
Standard Deviation 0.72
3.08 units on a 5-point response scale
Standard Deviation 0.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Social Influence
5.34 units on a scale
Standard Deviation 1.33
5.40 units on a scale
Standard Deviation 1.24
5.32 units on a scale
Standard Deviation 1.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Worry
2.62 units on a scale
Standard Deviation 0.99
2.66 units on a scale
Standard Deviation 0.82
2.78 units on a scale
Standard Deviation 1.01

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately post-intervention

Population: Participants who completed the baseline survey, intervention, and immediate post-intervention survey

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.

Outcome measures

Outcome measures
Measure
Information Only
n=159 Participants
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.
Screener Narrative
n=155 Participants
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.
Survivor Narrative
n=159 Participants
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.
Perceived Benefits and Barriers of Colorectal Cancer Screening
Perceived barriers
3.15 units on a scale
Standard Deviation 1.34
3.15 units on a scale
Standard Deviation 1.29
3.10 units on a scale
Standard Deviation 1.34
Perceived Benefits and Barriers of Colorectal Cancer Screening
Perceived benefits
5.98 units on a scale
Standard Deviation 0.92
6.08 units on a scale
Standard Deviation 0.93
5.92 units on a scale
Standard Deviation 1.00

Adverse Events

Information Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Screener Narrative

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Survivor Narrative

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy McQueen

Washington University in St. Louis

Phone: 3142862016

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place