Evaluation of Letters Promoting Colorectal Cancer Testing

Study Overview
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Brief Summary
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In this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. The researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).

Detailed Description
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Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. Mailing fecal immunochemical (FIT) kits to at-risk patients is an effective way of increasing CRC testing uptake, as this test can be done at home and is less intrusive compared to colonoscopies. As part of an existing program, the health system mails FIT kits to eligible patients each year. Although this test needs to be conducted annually, not everyone who receives the test kit returns the kits for processing. In this study, the researchers aim to test different letters with the goal of encouraging the use of FIT kits or scheduling a colonoscopy. As part of this study, the kits are mailed with everything the patient will need to conduct the test at home and mail a sample back to the hospital. It also includes an introductory letter informing the patient about the program and inviting them to use the kit. The researchers are comparing a standard version of the introductory letter against 3 versions that include different combinations of behavioral nudges, specifically framing effects (loss, default, decoy) and fear appeals.

Official Title
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Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies

Conditions
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Cancer Colorectal

Intervention / Treatment
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* Behavioral: Letter
* Behavioral: Loss Frame and Fear Appeals
* Behavioral: Transparency
* Behavioral: Default Effect and Presentation of Alternatives
* Behavioral: Enhanced Fear Appeals and Decoy Effect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in Medicare Health Maintenance Organization (HMO) and Preferred Provider Organization (PPO; age 65 and older) or Commercial HMO in one large employer's group Has a flag indicating that the person is due for a colon cancer screening Exclusion Criteria: - Members who are on the do not contact list at Geisinger Health Plan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 1 x 4 design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Letter<br>The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home. | Behavioral: Letter<br>* Recipients receive a letter promoting CRC screening.<br>|
| Experimental: Letter with Risks<br>The standard letter is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; it also explains why test kits are being sent to disarm skepticism about the program. | Behavioral: Letter<br>* Recipients receive a letter promoting CRC screening.<br>Behavioral: Loss Frame and Fear Appeals<br>* The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.<br>Behavioral: Transparency<br>* The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.<br>|
| Experimental: Letter with Risks and Options<br>In addition to the enhancements added by the letter with risks, the letter also includes a table comparing FIT kit and colonoscopy. Presenting different screening options allows recipients to make the choice that best suits them. In addition, presenting multiple options increases the chance that recipients get screened in one way or another. | Behavioral: Letter<br>* Recipients receive a letter promoting CRC screening.<br>Behavioral: Loss Frame and Fear Appeals<br>* The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.<br>Behavioral: Default Effect and Presentation of Alternatives<br>* The pros and cons for screening with FIT kits and colonoscopy are presented. By showing an additional option, the table frames the FIT kit as the default option (since they are included in the mailer). In this situation, inaction is no longer the default option. Changing the default option increases the chance that the FIT kit is used. In addition, another viable alternative is provided (colonoscopy), which still contributes to the goal of the project (getting screened).<br>Behavioral: Enhanced Fear Appeals and Decoy Effect<br>* Comparisons of the mortality rates between screening with FIT kits, colonoscopy, and inaction (waiting for symptoms to appear) are displayed. Inaction is presented as a decoy, which has worse outcomes than either of the screening options. Due to this contrast, the inclusion of the decoy increases the appeal of the other screening options.<br>|
| Experimental: Letter with Risks, Options, and Consequences for Inaction<br>In addition to the enhancements added by the letter with risk, the comparison table includes comparisons of the consequences of getting screened vs. waiting for symptoms to appear. | Behavioral: Letter<br>* Recipients receive a letter promoting CRC screening.<br>Behavioral: Loss Frame and Fear Appeals<br>* The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.<br>Behavioral: Enhanced Fear Appeals and Decoy Effect<br>* Comparisons of the mortality rates between screening with FIT kits, colonoscopy, and inaction (waiting for symptoms to appear) are displayed. Inaction is presented as a decoy, which has worse outcomes than either of the screening options. Due to this contrast, the inclusion of the decoy increases the appeal of the other screening options.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT Kit Return at 6 months | Binary variable indicating whether a valid FIT kit was returned for testing | 6 months from intervention start date | 
| Colonoscopy Ordered at 6 months | Binary variable indicating whether a colonoscopy was ordered | 6 months from intervention start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT Kit Return at 12 months | Binary variable indicating whether a valid FIT kit was returned for testing (a longer time frame allows for late responses) | 12 months from intervention start date | 
| Colonoscopy Ordered at 12 months | Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses) | 12 months from intervention start date | 
| FIT Kit Result | Binary variable indicating whether the test was positive or negative (if FIT kit was returned) | 12 months from intervention start date | 
| Colonoscopy Completed | Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered) | 12 months from intervention start date | 
| Colonoscopy Result | Binary variable indicating whether the test was positive or negative (if colonoscopy was completed) | 12 months from intervention start date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Screening, Communication, Occult Blood, Colonoscopy, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Framing, Fear Appeals, Default Effect, Decoy Effect