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.


Background: Screening decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Screening breakdowns arise from lack of uptake and failure to follow-up after a positive screening test.

Objectives: Systems of support to increase colorectal cancer screening and follow-up (SOS) is a randomized trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design.

Methods: The setting is a large nonprofit healthcare organization. In part-1 study, patients age 50-75 due for CRC screening are randomized to one of 4 study conditions. Arm 1 receives usual care. Arm 2 receives automated support (mailed information about screening choices and fecal occult blood tests (FOBT)). Arm 3 receives automated and assisted support (a medical assistant telephone call). Arm 4 receives automated, assisted, and care management support (a registered nurse provides behavioral activation and coordination of care). In part-2, study patients with a positive FOBT or adenomas on flexible sigmoidoscopy are randomized to receive either usual care or nurse care management. Primary outcomes are: 1) the proportion with CRC screening, 2) the proportion with a complete diagnostic evaluation after a positive screening test.

Results: We sent recruitment letters to 15,414 patients and 4675 were randomized. Randomly assigned treatment groups were similar in age, sex, race, education, self-reported health, and CRC screening history.

Conclusions: We will determine the effectiveness and cost effectiveness of stepped increases in systems of support to increase CRC screening and follow-up after a positive screening test over 2years.

Trial registration: NCT00697047.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Allied Health Personnel
  • Colonoscopy
  • Colorectal Neoplasms / diagnosis
  • Colorectal Neoplasms / prevention & control*
  • Data Collection
  • Female
  • Humans
  • Male
  • Mass Screening*
  • Middle Aged
  • Nursing Care
  • Nursing Staff, Hospital
  • Occult Blood
  • Patient Compliance*
  • Patient Selection*
  • Practice Guidelines as Topic
  • Quality Control
  • Registries
  • Reminder Systems
  • Research Design*
  • Sample Size
  • Sigmoidoscopy
  • Telephone

Associated data