NCT03080701

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

March 23, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1.6 years

First QC Date

January 31, 2017

Last Update Submit

November 4, 2019

Conditions

Keywords

Behavioral: Automated Mailing

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (3)

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

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.

Behavioral: Auto Mailing Plus Lottery

Interventions

Participant receives money as a thank you for completing CRC screening within 6 months.

Group 2 - Auto Mailing Plus Money

Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.

Group 3 - Auto Mailing Plus Lottery

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known high risk for CRC
  • History of CRC
  • History of inflammatory bowel disease
  • Current anticoagulation therapy
  • Organ failure
  • Serious illness
  • Debilitating disease
  • Dementia
  • Nursing home resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Beverly B Green, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The randomization sequence will be concealed to everyone except the study biostatistician.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

March 15, 2017

Study Start

March 23, 2017

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations