Know Cancer

forgot password

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

50 Years
73 Years
Open (Enrolling)
Colorectal Cancer Screening

Thank you

Trial Information

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

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

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

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

Inclusion Criteria:

- Not up to date on CRCS

- Continuously enrolled in 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

Colorectal cancer screening rates (as defined by both the NCQA HEDIS measure and the American Cancer Society), and follow-up rates after a positive screening test.

Outcome Time Frame:

Baseline, 12 mo f/u, 24 mo f/u, and 6mo after positive screening test

Safety Issue:


Principal Investigator

Beverly B Green, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Group Health Cooperative


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

May 2013

Related Keywords:

  • Colorectal Cancer Screening
  • Colorectal Neoplasms
  • Mass Screening
  • Population Surveillance
  • Randomized controlled trial
  • Occult Blood
  • Colonoscopy
  • Sigmoidoscopy
  • Health Behavior
  • Colonic Neoplasms
  • Colorectal Neoplasms



Group Health Research Institute Seattle, Washington  98101