Evaluation of Letters Promoting Colorectal Cancer Testing

NCT ID: NCT04548765

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14644 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-24
• Study Completion Date: 2021-07-23

Brief Summary

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

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.

Conditions

Cancer Colorectal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Standard Letter

The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home.

Group Type: ACTIVE_COMPARATOR

Letter

Intervention Type: BEHAVIORAL

Recipients receive a letter promoting CRC screening.

Letter with Risks

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.

Group Type: EXPERIMENTAL

Letter

Intervention Type: BEHAVIORAL

Recipients receive a letter promoting CRC screening.

Loss Frame and Fear Appeals

Intervention Type: BEHAVIORAL

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.

Transparency

Intervention Type: BEHAVIORAL

The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.

Letter with Risks and Options

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.

Group Type: EXPERIMENTAL

Letter

Intervention Type: BEHAVIORAL

Recipients receive a letter promoting CRC screening.

Loss Frame and Fear Appeals

Intervention Type: BEHAVIORAL

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.

Default Effect and Presentation of Alternatives

Intervention Type: BEHAVIORAL

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).

Enhanced Fear Appeals and Decoy Effect

Intervention Type: BEHAVIORAL

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.

Letter with Risks, Options, and Consequences for Inaction

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.

Group Type: EXPERIMENTAL

Letter

Intervention Type: BEHAVIORAL

Recipients receive a letter promoting CRC screening.

Loss Frame and Fear Appeals

Intervention Type: BEHAVIORAL

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.

Enhanced Fear Appeals and Decoy Effect

Intervention Type: BEHAVIORAL

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.

Interventions

Letter

Recipients receive a letter promoting CRC screening.

Intervention Type: BEHAVIORAL

Loss Frame and Fear Appeals

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.

Intervention Type: BEHAVIORAL

Transparency

The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.

Intervention Type: BEHAVIORAL

Default Effect and Presentation of Alternatives

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).

Intervention Type: BEHAVIORAL

Enhanced Fear Appeals and Decoy Effect

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Goren

Program Director, Behavioral Insights Team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Goren, PhD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-0510

Identifier Type: -

Identifier Source: org_study_id