Evaluation of Letters Promoting Colorectal Cancer Testing

Cancer Colorectal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548765
• Other study ID #: 2020-0510
• Status: Completed
• Phase: N/A
• Start date: July 24, 2020
• Est. completion date: July 23, 2021

Study information

• Verified date: September 2021
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14644
• Est. completion date: July 23, 2021
• Est. primary completion date: January 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colorectal
• Colorectal Neoplasms

Intervention

Behavioral:
• Letter
Recipients receive a letter promoting CRC screening.
• 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.
• Transparency
The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.
• 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).
• 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.

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT Kit Return at 6 months	Binary variable indicating whether a valid FIT kit was returned for testing	6 months from intervention start date
Primary	Colonoscopy Ordered at 6 months	Binary variable indicating whether a colonoscopy was ordered	6 months from intervention start date
Secondary	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
Secondary	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
Secondary	FIT Kit Result	Binary variable indicating whether the test was positive or negative (if FIT kit was returned)	12 months from intervention start date
Secondary	Colonoscopy Completed	Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)	12 months from intervention start date
Secondary	Colonoscopy Result	Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)	12 months from intervention start date