Evaluation of Letters Promoting Colorectal Cancer Testing
Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies
1 other identifier
interventional
14,644
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2020
CompletedFirst Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2021
CompletedSeptember 24, 2021
September 1, 2021
6 months
September 4, 2020
September 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
FIT Kit Return at 12 months
12 months from intervention start date
Colonoscopy Ordered at 12 months
12 months from intervention start date
FIT Kit Result
12 months from intervention start date
Colonoscopy Completed
12 months from intervention start date
Colonoscopy Result
12 months from intervention start date
Study Arms (4)
Standard Letter
ACTIVE COMPARATORThe standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home.
Letter with Risks
EXPERIMENTALThe 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.
Letter with Risks and Options
EXPERIMENTALIn 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.
Letter with Risks, Options, and Consequences for Inaction
EXPERIMENTALIn 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.
Interventions
Recipients receive a letter promoting CRC screening.
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.
The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Members who are on the do not contact list at Geisinger Health Plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
Study Sites (1)
Geisinger
Danville, Pennsylvania, 17822, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Goren, PhD
Geisinger Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Participants and providers are not aware of the different letter versions.
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director, Behavioral Insights Team
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 16, 2020
Study Start
July 24, 2020
Primary Completion
January 24, 2021
Study Completion
July 23, 2021
Last Updated
September 24, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
- Access Criteria
- The data on the Open Science Framework will be open to anyone requesting that information.
Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.