Clinical trial NCT04548765: Evaluation of Letters Promoting Colorectal Cancer Testing
Official title: Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Colorectal
Keywords: Mass Screening
Communication
Occult Blood
Colonoscopy
Risk Reduction Behavior
Economics, Behavioral
Psychology
Loss Framing
Fear Appeals
Default Effect
Decoy Effect
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 14644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1 x 4 design
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: FIT Kit Return at 6 months
timeFrame: 6 months from intervention start date
measure: Colonoscopy Ordered at 6 months
timeFrame: 6 months from intervention start date
Secondary outcomes:
measure: FIT Kit Return at 12 months
timeFrame: 12 months from intervention start date
measure: Colonoscopy Ordered at 12 months
timeFrame: 12 months from intervention start date
measure: FIT Kit Result
timeFrame: 12 months from intervention start date
measure: Colonoscopy Completed
timeFrame: 12 months from intervention start date
measure: Colonoscopy Result
timeFrame: 12 months from intervention start date
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References: