Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Receipt of mailed Cologuard test for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 3 years. If test is positive, participant will be advised to schedule colonoscopy for further testing.

Receipt of mailed FIT for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 1 year. If test is positive, participant will be advised to schedule colonoscopy for further testing.

Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.

Cologuard

Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Fecal Immunochemical Test

Joshua Demb, PhD, MPH

Samir Gupta, MD, MSCS

Joshua Demb, PhD

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)

Head to Head Mailed Cologuard to Mailed FIT

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)

Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.

Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy

Measurement of feasibility of mailed outreach

Measurement of number of adenomas detected during study period

Measurement of number of sessile serrated lesions detected during study period

Number of colorectal cancers detected during study period

University of California, San Diego

Postdoctoral Scholar

Colonic Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Cola

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

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

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

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.

Health communication intervention

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.

Education information

Amy McQueen, PhD

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

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).

Evaluating Strategies to Present Colon Cancer Screening Information

Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening

A data sharing agreement with an interested researcher that complies with federal, university, and institution review board standards for protecting data.

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 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 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.

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.

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.

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.

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.

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.

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 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.

National Cancer Institute (NCI)

Washington University School of Medicine

Assistant Professor

The only foreseeable adverse events that could arise from participation in the online study included negative affect including cancer worry as a result of reading about colorectal cancer risk, or a breach of confidentiality by researchers or hackers.

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.

Information Only

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.

Screener 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.

Survivor Narrative

Total

Age, Continuous

Sex: Female, Male

Caucasian/White

African American/Black

Other race

Race/Ethnicity, Customized

Receipt of any colorectal screening test (i.e., home stool blood test, sigmoidoscopy, colonoscopy)

Any prior colorectal cancer screening

Participants who completed the baseline survey and were randomized to receive the assigned study intervention

Amy McQueen

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

Intentions to Get Screened for Colon Cancer

Perceived similarity

Liking of character

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

Identification With the Character

Emotional engagement

Cognitive engagement

Self-referencing engagement

Three Measures of Engagement

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego
Evaluating Strategies to Present Colon Cancer Screening Information	NCT02485561	Colonic Neoplas... Colorectal Neop... Colonic Disease... Gastrointestina...	Health communic... Education infor...	50 Years - 75 Years	Washington University School of Medicine
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego
Head to Head Mailed Cologuard to Mailed FIT	NCT06173375	Colorectal Canc...	Cologuard Fecal Immunoche...	45 Years - 49 Years	University of California, San Diego

Spots Global Cancer Trial Database for stool blood test