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Sponsors and Collaborators: |
Group Health Cooperative Kaiser Permanente Fred Hutchinson Cancer Research Center |
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Information provided by: | Group Health Cooperative |
ClinicalTrials.gov Identifier: | NCT00697047 |
SOS is a four-arm randomized controlled study of ways to increase screening for colonrectal 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.
Condition | Intervention |
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Colorectal Cancer Screening |
Behavioral: Usual care plus automated mailing Behavioral: Usual care, automated mailing plus phone assistance by a medical assistant Behavioral: Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Systems of Support to Increase Colon Cancer Screening and Follow-up |
Estimated Enrollment: | 6200 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Usual Care
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2: Experimental
Usual care plus automated mailing
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Behavioral: Usual care plus automated mailing
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)
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3: Experimental
Usual care, automated mailing plus phone assistance by a medical assistant who helps patients clarify screening intent and refers care (such as ordering a screening colonoscopy) back to the patient's physician.
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Behavioral: Usual care, automated mailing plus phone assistance by a medical assistant
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)
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4: Experimental
Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening (assesses risks related to screening tests, counsels and assists patient in making a screening choice, and arranges the screening plan).
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Behavioral: Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)
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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.
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 follow-up after a positive screening test.
The secondary aims are:
Ages Eligible for Study: | 50 Years to 73 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lynda T Tyll, RN, MS | 206-287-2939 | tyll.l@ghc.org |
Contact: Beverly B Green, MY, MPH | 206-287-2997 | green.b@ghc.org |
United States, Washington | |
Group Health Cooperative -Center for Health Studies | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Beverly B Green, MD, MPH | Group Health Cooperative |
Responsible Party: | Group Health Cooperative, Center for Health Studies ( Beverly B. Green, MD, MPH (Principal Investigator) ) |
Study ID Numbers: | 5RO1CA121125, CFDA: 93.393, OC: 414E, PCC:4KHE |
Study First Received: | June 11, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697047 |
Health Authority: | United States: Institutional Review Board |
Colorectal Neoplasms Mass Screening Population Surveillance Randomized controlled trial |
Occult Blood Colonoscopy Sigmoidoscopy Health Behavior |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |