search
Back to results

Evaluation of Letters Promoting Colorectal Cancer Testing

Primary Purpose

Cancer Colorectal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Letter
Loss Frame and Fear Appeals
Transparency
Default Effect and Presentation of Alternatives
Enhanced Fear Appeals and Decoy Effect
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer Colorectal focused on measuring Mass Screening, Communication, Occult Blood, Colonoscopy, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Framing, Fear Appeals, Default Effect, Decoy Effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Geisinger

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standard Letter

Letter with Risks

Letter with Risks and Options

Letter with Risks, Options, and Consequences for Inaction

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

FIT Kit Return at 6 months
Binary variable indicating whether a valid FIT kit was returned for testing
Colonoscopy Ordered at 6 months
Binary variable indicating whether a colonoscopy was ordered

Secondary Outcome Measures

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)
Colonoscopy Ordered at 12 months
Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)
FIT Kit Result
Binary variable indicating whether the test was positive or negative (if FIT kit was returned)
Colonoscopy Completed
Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)
Colonoscopy Result
Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)

Full Information

First Posted
September 4, 2020
Last Updated
September 22, 2021
Sponsor
Geisinger Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04548765
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
January 24, 2021 (Actual)
Study Completion Date
July 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Colorectal
Keywords
Mass Screening, Communication, Occult Blood, Colonoscopy, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Framing, Fear Appeals, Default Effect, Decoy Effect

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
1 x 4 design
Masking
ParticipantCare Provider
Masking Description
Participants and providers are not aware of the different letter versions.
Allocation
Randomized
Enrollment
14644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Letter
Arm Type
Active Comparator
Arm Description
The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home.
Arm Title
Letter with Risks
Arm Type
Experimental
Arm Description
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.
Arm Title
Letter with Risks and Options
Arm Type
Experimental
Arm Description
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.
Arm Title
Letter with Risks, Options, and Consequences for Inaction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Letter
Intervention Description
Recipients receive a letter promoting CRC screening.
Intervention Type
Behavioral
Intervention Name(s)
Loss Frame and Fear Appeals
Intervention Description
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
Intervention Name(s)
Transparency
Intervention Description
The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.
Intervention Type
Behavioral
Intervention Name(s)
Default Effect and Presentation of Alternatives
Intervention Description
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
Intervention Name(s)
Enhanced Fear Appeals and Decoy Effect
Intervention Description
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.
Primary Outcome Measure Information:
Title
FIT Kit Return at 6 months
Description
Binary variable indicating whether a valid FIT kit was returned for testing
Time Frame
6 months from intervention start date
Title
Colonoscopy Ordered at 6 months
Description
Binary variable indicating whether a colonoscopy was ordered
Time Frame
6 months from intervention start date
Secondary Outcome Measure Information:
Title
FIT Kit Return at 12 months
Description
Binary variable indicating whether a valid FIT kit was returned for testing (a longer time frame allows for late responses)
Time Frame
12 months from intervention start date
Title
Colonoscopy Ordered at 12 months
Description
Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)
Time Frame
12 months from intervention start date
Title
FIT Kit Result
Description
Binary variable indicating whether the test was positive or negative (if FIT kit was returned)
Time Frame
12 months from intervention start date
Title
Colonoscopy Completed
Description
Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)
Time Frame
12 months from intervention start date
Title
Colonoscopy Result
Description
Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)
Time Frame
12 months from intervention start date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Goren, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
IPD Sharing URL
http://osf.io

Learn more about this trial

Evaluation of Letters Promoting Colorectal Cancer Testing

We'll reach out to this number within 24 hrs