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Completed

NCT Number: NCT04548765

Evaluation of Letters Promoting Colorectal Cancer Testing

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).

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Key information

Conditions

Cancer Colorectal Behavior Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Communication Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Risk Reduction Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letter

Behavioral

Recipients receive a letter promoting CRC screening.

Loss Frame and Fear Appeals

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

Behavioral

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

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

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.

Primary outcomes

  1. FIT Kit Return at 6 months

    Time frame: 6 months from intervention start date

    Binary variable indicating whether a valid FIT kit was returned for testing

  2. Colonoscopy Ordered at 6 months

    Time frame: 6 months from intervention start date

    Binary variable indicating whether a colonoscopy was ordered

Secondary outcomes

  1. FIT Kit Return at 12 months

    Time frame: 12 months from intervention start date

    Binary variable indicating whether a valid FIT kit was returned for testing (a longer time frame allows for late responses)

  2. Colonoscopy Ordered at 12 months

    Time frame: 12 months from intervention start date

    Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)

  3. FIT Kit Result

    Time frame: 12 months from intervention start date

    Binary variable indicating whether the test was positive or negative (if FIT kit was returned)

  4. Colonoscopy Completed

    Time frame: 12 months from intervention start date

    Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)

  5. Colonoscopy Result

    Time frame: 12 months from intervention start date

    Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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