Cancer ColorectalNCT04548765
Evaluation of Letters Promoting Colorectal Cancer Testing
A study testing Letter, Loss Frame and Fear Appeals and Transparency in people with Cancer Colorectal, run by Geisinger Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Letter, Loss Frame and Fear Appeals and Transparency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,644 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2020to 23 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Members who are on the do not contact list at Geisinger Health Plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies
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).
Read the 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.
- Conditions
- Cancer Colorectal
- Being tested
- Letter, Loss Frame and Fear Appeals, Transparency, Default Effect and Presentation of Alternatives, Enhanced Fear Appeals and Decoy Effect
- Keywords
- Mass Screening, Communication, Occult Blood, Colonoscopy, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Framing, Fear Appeals, Default Effect, Decoy Effect
- Medical subject headings
- Colonic Neoplasms, Communication, Risk Reduction Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
Recipients receive a letter promoting CRC screening.
Loss Frame and Fear AppealsBehavioural
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.
TransparencyBehavioural
The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.
Default Effect and Presentation of AlternativesBehavioural
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 EffectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Letter | Active comparator | The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home. Receives: Behavioral: Letter |
| Letter with Risks | Experimental | 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. Receives: Behavioral: Letter; Behavioral: Loss Frame and Fear Appeals; Behavioral: Transparency |
| Letter with Risks and Options | Experimental | 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. Receives: Behavioral: Letter; Behavioral: Loss Frame and Fear Appeals; Behavioral: Default Effect and Presentation of Alternatives; Behavioral: Enhanced Fear Appeals and Decoy Effect |
| Letter with Risks, Options, and Consequences for Inaction | Experimental | 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. Receives: Behavioral: Letter; Behavioral: Loss Frame and Fear Appeals; Behavioral: Enhanced Fear Appeals and Decoy Effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT Kit Return at 6 months
Binary variable indicating whether a valid FIT kit was returned for testing
Measured: 6 months from intervention start date
Colonoscopy Ordered at 6 months
Binary variable indicating whether a colonoscopy was ordered
Measured: 6 months from intervention start date
Secondary outcomes (5)
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)
Measured: 12 months from intervention start date
Colonoscopy Ordered at 12 months
Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)
Measured: 12 months from intervention start date
FIT Kit Result
Binary variable indicating whether the test was positive or negative (if FIT kit was returned)
Measured: 12 months from intervention start date
Colonoscopy Completed
Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)
Measured: 12 months from intervention start date
Colonoscopy Result
Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)
Measured: 12 months from intervention start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start24 Jul 2020
- Primary completion24 Jan 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 1 x 4 design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548765
- Sponsor's protocol ID
- 2020-0510
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies
- ClinicalTrials.gov ID
- NCT04548765
- Acronym / sponsor ID
- 2020-0510
- Conditions
- Cancer Colorectal
- Keywords
- Mass Screening, Communication, Occult Blood, Colonoscopy, Risk Reduction Behavior, Economics, Behavioral, Psychology, Loss Framing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,644 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 1 x 4 design
| Arm | Type | Receives |
|---|---|---|
| Standard Letter | Active comparator | Behavioral: LetterThe standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home. |
| Letter with Risks | Experimental | Behavioral: Letter, Behavioral: Loss Frame and Fear Appeals, Behavioral: TransparencyThe 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 | Experimental | Behavioral: Letter, Behavioral: Loss Frame and Fear Appeals, Behavioral: Default Effect and Presentation of Alternatives, Behavioral: Enhanced Fear Appeals and Decoy EffectIn 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 | Experimental | Behavioral: Letter, Behavioral: Loss Frame and Fear Appeals, Behavioral: Enhanced Fear Appeals and Decoy EffectIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Members who are on the do not contact list at Geisinger Health Plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetterRecipients receive a letter promoting CRC screening. | Behavioural | Letter with Risks, Letter with Risks and Options, Letter with Risks, Options, and Consequences for Inaction, Standard Letter |
| Loss Frame and Fear AppealsThe 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. | Behavioural | Letter with Risks, Letter with Risks and Options, Letter with Risks, Options, and Consequences for Inaction |
| TransparencyThe letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient. | Behavioural | Letter with Risks |
| Default Effect and Presentation of AlternativesThe 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). | Behavioural | Letter with Risks and Options |
| Enhanced Fear Appeals and Decoy EffectComparisons 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. | Behavioural | Letter with Risks and Options, Letter with Risks, Options, and Consequences for Inaction |
Primary outcome
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
Colonoscopy Ordered at 6 months
Time frame: 6 months from intervention start date
Binary variable indicating whether a colonoscopy was ordered
5 secondary outcomes
FIT Kit Return at 12 months
Time frame: 12 months from intervention start date
Colonoscopy Ordered at 12 months
Time frame: 12 months from intervention start date
FIT Kit Result
Time frame: 12 months from intervention start date
Colonoscopy Completed
Time frame: 12 months from intervention start date
Colonoscopy Result
Time frame: 12 months from intervention start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Goren, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter, Loss Frame and Fear Appeals and Transparency in people with Cancer Colorectal, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT Kit Return at 6 months (time frame: 6 months from intervention start date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.