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Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Mailing
Automated Mailing Plus Assisted
Auto Plus Assisted Plus Navigation
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior, Colorectal Screening

Eligibility Criteria

50 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

1- Usual Care

2 - Automated Mailing

3 - Automated Mailing Plus Assisted

4 - Auto Plus Assisted Plus Navigation

Arm Description

Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.

Usual 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.

Usual 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).

Usual 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3
To compare adherence to CRC screening, among those randomized to receive continued interventions compared to stopped interventions: a) during year 3; b) over the 7 years of follow-up from re-randomization at year 3 through the end of year 9.
Impact of SOS interventions on outcomes and CRC-related costs
To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness.

Full Information

First Posted
June 11, 2008
Last Updated
October 30, 2020
Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00697047
Brief Title
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up
Acronym
SOS
Official Title
Systems of Support to Increase Colon Cancer Screening and Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Fred Hutchinson Cancer Center, The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up A. Specific Aims There is strong evidence that colorectal cancer screening (CRCS) decreases colorectal cancer (CRC) mortality and reduces colorectal cancer incidence. Despite the efficacy of screening, 40-60% of eligible adults are not screened at recommended intervals, and many have never had any type of CRCS. Screening failures occur not only from lack of screening but also from breakdowns in follow-up of positive tests, which obviates the benefits of screening. Strategies for improving the uptake of CRCS typically focus on either patients or health care providers, without describing the infrastructure changes, or systems of support (SOS), that are required to implement and sustain these changes. We propose a two-part study using the Chronic Care Model to organize SOS. We will identify a cohort of Group Health patients aged 50 -73 years who have not had a colonoscopy (CS) in 10 years, a flexible sigmoidoscopy (FS) in 5 years, or a fecal occult blood test (FOBT) in 10 months. Part One: Subjects will be randomized to receive one of four interventions of stepwise increasing intensity of support. Usual care (UC). Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card). Assisted (UC + automated + a medical assistant) to document screening intent and assists patients via the resources already supplied or sending requests to the patient's physician. Care management (UC + automated + assisted + cancer screening nurse support) who counsels patient and assists with this screening plan (assessing procedural risk, and ordering tests). Part Two: Patients with a positive FOBT or a positive FS (CS needed) will be randomized to one of two follow-up intervention arms: A. Usual care (which at Group Health includes a registry and physician alerts) or B. Care Management (UC + cancer screening nurse who manages care after a positive test). Our study hypotheses are that increasing levels of SOS will result in increasing CRCS rates, and care management by cancer screening nurses will increase follow-up rates after a positive test. The primary specific aims are: To compare the effectiveness of each intervention condition on increasing CRCS rates. To compare the effectiveness of each intervention condition on follow-up after a positive screening test. The secondary aims are: To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior, Colorectal Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1- Usual Care
Arm Type
No Intervention
Arm Description
Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.
Arm Title
2 - Automated Mailing
Arm Type
Experimental
Arm Description
Usual 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.
Arm Title
3 - Automated Mailing Plus Assisted
Arm Type
Experimental
Arm Description
Usual 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).
Arm Title
4 - Auto Plus Assisted Plus Navigation
Arm Type
Experimental
Arm Description
Usual 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.
Intervention Type
Behavioral
Intervention Name(s)
Automated Mailing
Intervention Description
Usual Care plus Automated mailing
Intervention Type
Behavioral
Intervention Name(s)
Automated Mailing Plus Assisted
Intervention Description
If not screened after automated mailing, MA assists with screening.
Intervention Type
Behavioral
Intervention Name(s)
Auto Plus Assisted Plus Navigation
Intervention Description
If not screened after automated mailing and assistance by MA, RN begins navigation.
Primary Outcome Measure Information:
Title
Short-term adherence to CRC screening
Description
To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.
Time Frame
From randomization to the end of 2 years
Title
Long-term adherence to CRC screening
Description
To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).
Time Frame
From randomization to the end of 9 years
Secondary Outcome Measure Information:
Title
Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3
Description
To compare adherence to CRC screening, among those randomized to receive continued interventions compared to stopped interventions: a) during year 3; b) over the 7 years of follow-up from re-randomization at year 3 through the end of year 9.
Time Frame
From year 3 to the end of 9 years
Title
Impact of SOS interventions on outcomes and CRC-related costs
Description
To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness.
Time Frame
From randomization to the end of 9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly B Green, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
January 1, 2021 - December 31, 2030
IPD Sharing 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.
Citations:
PubMed Identifier
25998922
Citation
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.
Results Reference
result
PubMed Identifier
25381076
Citation
Green 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.
Results Reference
result
PubMed Identifier
20674774
Citation
Green 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. Erratum In: Contemp Clin Trials. 2012 Sep;33(5):1103.
Results Reference
result
PubMed Identifier
22424252
Citation
Green 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.
Results Reference
result
PubMed Identifier
23460053
Citation
Green 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.
Results Reference
result
PubMed Identifier
24891548
Citation
Wang 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.
Results Reference
result
PubMed Identifier
24937648
Citation
Murphy 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.
Results Reference
result
PubMed Identifier
26488332
Citation
Green 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.
Results Reference
result
PubMed Identifier
26957375
Citation
Green 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.
Results Reference
result
PubMed Identifier
34047921
Citation
Green 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.
Results Reference
derived
PubMed Identifier
31276178
Citation
Green 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.
Results Reference
derived
PubMed Identifier
28558663
Citation
Green 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.
Results Reference
derived

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Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up

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