Cancer is the second leading cause of death among U.S. adults, and colorectal cancer is the second leading cause of cancer-related deaths among U.S. men and women. In 2004, there were 145,083 new cases of colorectal cancer, and 53,580 people died of the disease (1). Although colorectal cancer affects both sexes and all races, men, African Americans, and Alaska Natives have disproportionately high incidences and mortality rates of colorectal cancer (2). In addition, colorectal cancer is expensive to treat: in 2004, the national cost of medical treatment for this disease was $8.4 billion (3).

Most colorectal cancers develop slowly from pre-existing polyps. This slow development provides an opportunity to intervene with screening tests, which can either prevent colorectal cancer through the removal of polyps or detect it at an early stage (4). Substantial scientific evidence shows that the incidence and mortality are reduced by regular screening (5-10). However, screening rates have been slow to increase (11), and it is not clear how best to implement an effective colorectal cancer screening program that reaches the people most in need. Uninsured persons, low-income persons, or those who have not seen a physician within the previous year are least likely to be screened (11).

The Centers for Disease Control and Prevention (CDC) has 15 years of experience supporting the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for the medically underserved population, but a similar national program for colorectal cancer is not in place (12). The NBCCEDP uses a comprehensive approach to breast and cervical cancer control, which includes providing early detection services, educational activities, public and private partnerships, and quality assurance measures. Clinically, screening for colorectal cancer is more complex than screening for either breast or cervical cancer because several screening tests are acceptable, each with a different recommended interval and each performed by different types of health care specialists. To understand better how to structure and implement population-level colorectal cancer screening and to explore which settings and program models are most viable and cost-effective, CDC began a 3-year colorectal cancer screening demonstration program in 2005. It was designed for low-income persons aged 50 to 64 years who are underinsured or uninsured for colorectal cancer screening.

This article describes briefly the process used to establish the CDC-funded Colorectal Cancer Screening Demonstration Program and the tools developed to implement this program. In accompanying reports in this issue of Preventing Chronic Disease (13-15), we present case-study and cost-study evaluation findings from the program start-up period, which we defined as beginning when the demonstration sites received their initial funds and ending when the screening itself began. Future reports will include evaluation results from the implementation phase of the program.

In the summer of 2004, CDC held two meetings with 58 invited stakeholders, including clinicians and health scientists from CDC, other federal health agencies, partner organizations such as the American Cancer Society and Prevent Cancer Foundation, state health departments, and health systems such as managed care organizations. Also in attendance were representatives from Australia, the United Kingdom, and Italy, many with experience in organized colorectal cancer screening programs. During these stakeholder meetings, we used published data, the combined experience of meeting attendees, and consensus opinion to make key decisions that helped define the demonstration program. These decisions included the following:

Of the 39 applicants who competed for funds to start a demonstration project, 5 were selected and awarded a combined $2.1 million for year 1 of a 3-year program beginning in 2005. The successful applicants were the Maryland Department of Health and Mental Hygiene; Missouri Department of Health and Senior Services; Nebraska Department of Health and Human Services; Public Health – Seattle & King County, Washington; and Stony Brook University Medical Center, New York. The program's structure and the screening tests selected for the program are described in Figure 1.

Each of the five programs is described in this issue of Preventing Chronic Disease (14). Program components in the five selected sites include clinical services (screening, surveillance, and diagnostic services), patient support, data collection and tracking, program management, public education and outreach, quality services measures, partnerships, and evaluation of program process and effectiveness. A multidisciplinary CDC team worked closely with the five selected sites during their start-up; the team included physicians, public health advisors, epidemiologists, program analysts, evaluators, health economists, data consultants, and health communications specialists.

During the start-up phase, which ranged from 9 to 11 months, CDC staff and program staff at each site collaborated to develop the program's materials and components. These include policies, a set of standard data elements (colorectal cancer clinical data elements or CCDEs), a data user's manual, data collection forms, a readiness checklist, a cost-assessment tool, and an evaluation plan. The cost-assessment tool and evaluation plan are described in another article in this issue of Preventing Chronic Disease (15). The readiness checklist, program policies, CCDEs, and data users' manual are available at http://www.cdc.gov/cancer/colorectal/what_is_cdc_doing/demonstration. Data collection forms were designed individually by each program site and are available on request.

A comprehensive evaluation of the colorectal cancer screening program is being conducted. It will provide information to guide our next steps. Evaluators engaged program and CDC stakeholders in developing a multisite and multiple-method evaluation to assess the program's implementation, outcomes, and efficiencies. Qualitative and quantitative evaluation approaches will be used 1) to analyze patient screening and diagnostic services, 2) to determine cost and cost-effectiveness, and 3) to conduct a longitudinal multiple-case study.

Colorectal cancer screening is rapidly becoming a priority at the local, state, and national levels. Several states (e.g., New York, Maryland) have long-standing programs; other states and cities (e.g., Colorado, New York City) recently began colorectal cancer screening; and others (e.g., Iowa, Wyoming) are planning to allocate new resources for organized colorectal cancer screening programs. CDC is working closely with the five demonstration program sites and communicating with other local and state partners who are taking steps toward establishing local or state programs so that lessons learned can be disseminated widely. Several pieces of legislation have been introduced into the U.S. Congress that, if passed, would establish a national colorectal cancer screening program.

Program activities for the demonstration sites will continue through August 2008. The evaluation findings published in this issue of Preventing Chronic Disease (13-15) and findings to be reported from the implementation phase of the demonstration program will be used to make adjustments during the demonstration period and to guide emerging programs and larger future efforts.