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

Colorectal Cancer Clinical Trial

— SOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697047
• Other study ID #: 5R01CA121125
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

1. Usual care (UC).

2. Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card).

3. 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.

4. 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:

1. To compare the effectiveness of each intervention condition on increasing CRCS rates.

2. To compare the effectiveness of each intervention condition on follow-up after a positive screening test.

The secondary aims are:

3. To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services

4. To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4653
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 73 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

Behavioral:
• Automated Mailing
Usual Care plus Automated mailing
• Automated Mailing Plus Assisted
If not screened after automated mailing, MA assists with screening.
• Auto Plus Assisted Plus Navigation
If not screened after automated mailing and assistance by MA, RN begins navigation.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Fred Hutchinson Cancer Research Center, The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.20 — View 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 — View 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.2014.06.1 — View 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 — View 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 — View 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 partic — View 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. — View 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 — View 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.EP — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	From year 3 to the end of 9 years
Secondary	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.	From randomization to the end of 9 years