Colorectal CancerNCT03080701
Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations
A study testing Auto Mailing Plus Money and Auto Mailing Plus Lottery in people with Colorectal Cancer, run by Kaiser Permanente at 1 site in United States.
Trial summary
The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Auto Mailing Plus Money and Auto Mailing Plus Lottery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 2 Nov 2018
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No evidence in electronic data of FIT screening in past year or a colonoscopy in the prior 9 years.
- Continuously enrolled in Group Health Cooperative (GHC) for at least one year.
- Patients who have Medicaid coverage or are non-white race or Hispanic any race.
Who cannot join
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
- Serious illness
Show all 9Show fewer
- Debilitating disease
- Dementia
- Nursing home resident
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Systems of Support (SOS) to Increase Colon Cancer Screening Disparities Supplement
The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. We will test whether financial incentives increases screening uptake and decreases screening disparities. The investigators hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.
Read the detailed description
Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for CRC screening, two-thirds who are identified in the electronic data as being from a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.
- Conditions
- Colorectal Cancer
- Being tested
- Auto Mailing Plus Money, Auto Mailing Plus Lottery
- Keywords
- Behavioral: Automated Mailing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto Mailing Plus MoneyBehavioural
Participant receives money as a thank you for completing CRC screening within 6 months.
Auto Mailing Plus LotteryBehavioural
Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Automated Mailing | No intervention | The mailing process will be identical to those used in the SOS study. Mailing 1 includes an introductory letter on CRC screening and a pamphlet on CRC testing choices (colonoscopy every 10 years, FIT testing yearly, or flexible sigmoidoscopy every 10 years combined with interval FIT testing), and pros and cons of each. The letter will state that they will soon be receiving a FIT kit in the mail, and a number to call if they prefer another option. Mailing 2 includes a brief letter reaffirming the importance of screening, a FIT kit (the one used by Group Health), pictograph instructions, and a postage-paid return envelope. Mailing 3 a reminder letter, is sent to participants not completing the FIT kit after 3 weeks. The intervention for Group 1 includes no incentive. |
| Group 2 - Auto Mailing Plus Money | Experimental | Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will receive a monetary thank you gift for completing testing (FIT colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the monetary thank you gift for CRC screening completion. Mailing 4 will include the money with a thank you letter for those who complete the screening Receives: Behavioral: Auto Mailing Plus Money |
| Group 3 - Auto Mailing Plus Lottery | Experimental | Receives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will have a 1 in 10 chance of winning money (FIT, colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the 1 in 10 chance of winning the lottery for CRC screening completion. Mailing 4 will include a thank you letter with money for those who complete their screening and win the lottery. Participants who do not win the lottery will receive a thank you letter. Receives: Behavioral: Auto Mailing Plus Lottery |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC Screening Within 6 Months Following Randomization
We will compare among the 3 arms (1) automated mailing; (2) Auto mailing plus $10; (3) Auto mailing plus $50 lottery for completion and the effect of each on CRC screening completion at 6 months (yes/no) within the following subgroups of each arm: 1. White and not Hispanic versus non-White or Hispanic. 2. Medicaid versus non-Medicaid (Medicare, employer-based, private) insurance. 3. History of prior versus no prior completion of CRC screening tests. 4. High school or less versus college or more education level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start23 Mar 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Texas
- Responsible party
- Sponsor
- Investigators
- Beverly B Green, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080701
- Sponsor's protocol ID
- 4RO1CA121125-09 REVISED
- Other IDs
- 4R01CA121125-09
- Status last verified
- Nov 2019
- First submitted
- 31 Jan 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems of Support (SOS) to Increase Colon Cancer Screening Disparities Supplement
- ClinicalTrials.gov ID
- NCT03080701
- Acronym / sponsor ID
- 4RO1CA121125-09 REVISED
- Conditions
- Colorectal Cancer
- Keywords
- Behavioral: Automated Mailing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Michigan, University of Texas
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 15 Mar 2017 (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.
The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. We will test whether financial incentives increases screening uptake and decreases screening disparities. The investigators hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.
Detailed description
Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for CRC screening, two-thirds who are identified in the electronic data as being from a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Automated Mailing | No intervention | –The mailing process will be identical to those used in the SOS study. Mailing 1 includes an introductory letter on CRC screening and a pamphlet on CRC testing choices (colonoscopy every 10 years, FIT testing yearly, or flexible sigmoidoscopy every 10 years combined with interval FIT testing), and pros and cons of each. The letter will state that they will soon be receiving a FIT kit in the mail, and a number to call if they prefer another option. Mailing 2 includes a brief letter reaffirming the importance of screening, a FIT kit (the one used by Group Health), pictograph instructions, and a postage-paid return envelope. Mailing 3 a reminder letter, is sent to participants not completing the FIT kit after 3 weeks. The intervention for Group 1 includes no incentive. |
| Group 2 - Auto Mailing Plus Money | Experimental | Behavioral: Auto Mailing Plus MoneyReceives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will receive a monetary thank you gift for completing testing (FIT colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the monetary thank you gift for CRC screening completion. Mailing 4 will include the money with a thank you letter for those who complete the screening |
| Group 3 - Auto Mailing Plus Lottery | Experimental | Behavioral: Auto Mailing Plus LotteryReceives the same number of mailings and materials as group 1 with the following modifications. In Mailing 1 the letter will include the intervention notification that they will have a 1 in 10 chance of winning money (FIT, colonoscopy or flex sig within 6 months). Mailing 2 and mailing 3 (reminder letters for those still not returning kits) will include the same information about the 1 in 10 chance of winning the lottery for CRC screening completion. Mailing 4 will include a thank you letter with money for those who complete their screening and win the lottery. Participants who do not win the lottery will receive a thank you letter. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No evidence in electronic data of FIT screening in past year or a colonoscopy in the prior 9 years.
- Continuously enrolled in Group Health Cooperative (GHC) for at least one year.
- Patients who have Medicaid coverage or are non-white race or Hispanic any race.
Key exclusion criteria (9 listed)
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
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 |
|---|---|---|
| Auto Mailing Plus MoneyParticipant receives money as a thank you for completing CRC screening within 6 months. | Behavioural | Group 2 - Auto Mailing Plus Money |
| Auto Mailing Plus LotteryParticipant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months. | Behavioural | Group 3 - Auto Mailing Plus Lottery |
Primary outcome
CRC Screening Within 6 Months Following Randomization
Time frame: 6 months
We will compare among the 3 arms (1) automated mailing; (2) Auto mailing plus $10; (3) Auto mailing plus $50 lottery for completion and the effect of each on CRC screening completion at 6 months (yes/no) within the following subgroups of each arm: 1. White and not Hispanic versus non-White or Hispanic. 2. Medicaid versus non-Medicaid (Medicare, employer-based, private) insurance. 3. History of prior versus no prior completion of CRC screening tests. 4. High school or less versus college or more education level.
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 5 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Beverly B Green, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto Mailing Plus Money and Auto Mailing Plus Lottery in people with Colorectal Cancer, run by Kaiser Permanente 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 3 inclusion and 9 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 5 Nov 2019. 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?
CRC Screening Within 6 Months Following Randomization (time frame: 6 months). 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 5 Nov 2019.