Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up
SOS
Systems of Support to Increase Colon Cancer Screening and Follow-up
1 other identifier
interventional
4,653
1 country
1
Brief Summary
SOS is a four-arm randomized controlled study of ways to increase screening for colorectal cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is a very important problem because screening both prevents colorectal cancer and decreases colon cancer deaths. We are studying 3 different levels of support to help people get screened and follow-up after positive screening tests. These involve comparing to usual care stepwise increasing in intensity approaches; an automated approach of mailing information and home screening tests, this plus phone assistance by a medical assistant, both of these plus phone counseling and care management. We will also compare nurse assisted follow-up after a positive screening test compared to usual care By doing this study we hope to increase colon cancer screening rates, and also follow-up rates for positive screening tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jul 2008
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedNovember 3, 2020
October 1, 2020
10.5 years
June 11, 2008
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Short-term adherence to CRC screening
To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.
From randomization to the end of 2 years
Long-term adherence to CRC screening
To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).
From randomization to the end of 9 years
Secondary Outcomes (2)
Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3
From year 3 to the end of 9 years
Impact of SOS interventions on outcomes and CRC-related costs
From randomization to the end of 9 years
Study Arms (4)
1- Usual Care
NO INTERVENTIONUsual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.
2 - Automated Mailing
EXPERIMENTALUsual care plus automated mailing. Mailing 1 is a pamphlet about screening choices and number to call for colonoscopy. Mailing 2 is a FIT kit if not requesting colonoscopy. Mailing 3 is a Reminder letter.
3 - Automated Mailing Plus Assisted
EXPERIMENTALUsual care, automated mailing plus, if screening is still not completed, phone assistance by a medical assistant (MA) who asks about patients screening intent, and provides brief assistance to complete this (e.g. sends another fecal test, assists with provider order for a colonoscopy).
4 - Auto Plus Assisted Plus Navigation
EXPERIMENTALUsual care, automated mailing, phone assistance by a medical assistant, plus navigation by a registered nurse (RN) if still not screened. Navigators are trained to use motivational interviewing techniques. They assess CRC and procedure risk, facilitate screening choice, address barriers, and provide follow-up until screening is completed.
Interventions
If not screened after automated mailing, MA assists with screening.
If not screened after automated mailing and assistance by MA, RN begins navigation.
Eligibility Criteria
You may qualify if:
- Not up to date on CRCS
- Continuously enrolled in Group Health Cooperative (GHC) for 24 months
- Expected to continue to be enrolled at GHC for 24 months.
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
- Kaiser Permanentelead
- Fred Hutchinson Cancer Centercollaborator
- The University of Texas Health Science Center, Houstoncollaborator
Study Sites (1)
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
Related Publications (12)
Meenan RT, Anderson ML, Chubak J, Vernon SW, Fuller S, Wang CY, Green BB. An economic evaluation of colorectal cancer screening in primary care practice. Am J Prev Med. 2015 Jun;48(6):714-21. doi: 10.1016/j.amepre.2014.12.016.
PMID: 25998922RESULTGreen BB, Anderson ML, Wang CY, Vernon SW, Chubak J, Meenan RT, Fuller S. Results of nurse navigator follow-up after positive colorectal cancer screening test: a randomized trial. J Am Board Fam Med. 2014 Nov-Dec;27(6):789-95. doi: 10.3122/jabfm.2014.06.140125.
PMID: 25381076RESULTGreen BB, Wang CY, Horner K, Catz S, Meenan RT, Vernon SW, Carrell D, Chubak J, Ko C, Laing S, Bogart A. Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants. Contemp Clin Trials. 2010 Nov;31(6):589-603. doi: 10.1016/j.cct.2010.07.012. Epub 2010 Jul 30.
PMID: 20674774RESULTGreen BB, Bogart A, Chubak J, Vernon SW, Morales LS, Meenan RT, Laing SS, Fuller S, Ko C, Wang CY. Nonparticipation in a population-based trial to increase colorectal cancer screening. Am J Prev Med. 2012 Apr;42(4):390-7. doi: 10.1016/j.amepre.2011.11.014.
PMID: 22424252RESULTGreen BB, Wang CY, Anderson ML, Chubak J, Meenan RT, Vernon SW, Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):301-11. doi: 10.7326/0003-4819-158-5-201303050-00002.
PMID: 23460053RESULTWang CY, de Dieu Tapsoba J, Anderson ML, Vernon SW, Chubak J, Fuller S, Green BB. Time to screening in the systems of support to increase colorectal cancer screening trial. Cancer Epidemiol Biomarkers Prev. 2014 Aug;23(8):1683-8. doi: 10.1158/1055-9965.EPI-14-0270. Epub 2014 Jun 2.
PMID: 24891548RESULTMurphy CC, Vernon SW, Haddock NM, Anderson ML, Chubak J, Green BB. Longitudinal predictors of colorectal cancer screening among participants in a randomized controlled trial. Prev Med. 2014 Sep;66:123-30. doi: 10.1016/j.ypmed.2014.06.013. Epub 2014 Jun 15.
PMID: 24937648RESULTGreen BB, Anderson ML, Chubak J, Fuller S, Meenan RT, Vernon SW. Impact of continued mailed fecal tests in the patient-centered medical home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up randomized trial. Cancer. 2016 Jan 15;122(2):312-21. doi: 10.1002/cncr.29734. Epub 2015 Oct 21.
PMID: 26488332RESULTGreen BB, Anderson ML, Chubak J, Baldwin LM, Tuzzio L, Catz S, Cole A, Vernon SW. Colorectal Cancer Screening Rates Increased after Exposure to the Patient-Centered Medical Home (PCMH). J Am Board Fam Med. 2016 Mar-Apr;29(2):191-200. doi: 10.3122/jabfm.2016.02.150290.
PMID: 26957375RESULTGreen BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Meenan RT, Vernon SW. A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial. J Gen Intern Med. 2022 Apr;37(5):1073-1080. doi: 10.1007/s11606-021-06922-2. Epub 2021 May 28.
PMID: 34047921DERIVEDGreen BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Kimbel KJ, Kullgren JT, Meenan RT, Vernon SW. Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e196570. doi: 10.1001/jamanetworkopen.2019.6570.
PMID: 31276178DERIVEDGreen BB, BlueSpruce J, Tuzzio L, Vernon SW, Aubree Shay L, Catz SL. Reasons for never and intermittent completion of colorectal cancer screening after receiving multiple rounds of mailed fecal tests. BMC Public Health. 2017 May 30;17(1):531. doi: 10.1186/s12889-017-4458-6.
PMID: 28558663DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly B Green, MD, MPH
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
July 1, 2008
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
November 3, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- January 1, 2021 - December 31, 2030
- Access Criteria
- Deidentified individual participant data and a data dictionary without investigator support will be made available upon request to Bev.B.Green@kp.org and approval.
Deidentified individual participant data and a data dictionary without investigator support will be made available upon request to Bev.B.Green@kp.org and approval. The final dataset will include patient data from computerized medical records and telephone interviews with subjects. This includes demographic data (automated data and self-report), diagnoses, laboratory and procedure results and utilization data. Data will be made available as study manuscripts are published and will be de-identified prior to release for sharing.