July 22, 2014
Open Door Participating in STOP CRC: Screen to Prevent Colorectal Cancer
Four of the Open Door Community Health Centers will be taking part in a study called STOP CRC (Screen to Prevent Colorectal Cancer) to determine the effectiveness of a strategy aimed at increasing the screening rate for colorectal cancer (CRC) in the appropriate population, namely adults between the ages of 50 and 75. Open Door’s participation will begin in June, 2014 and continue for two years. A total of 22 other community clinics will be study sites, all these located in Oregon.
The principal investigators for the study are Gloria Coronado, Ph.D. at the Kaiser Permanente Center for Health Research in Portland, OR and Beverly Green, M.D., M.P.H. at the Group Health Research Institute in Seattle, WA.
The four Open Door clinics which will be part of this study are Eureka Community Health and Wellness Center, Humboldt Open Door Clinic, North Country Clinic, and McKinleyville Community Health Center. Two of these will be intervention sites and the other two control sites, i.e., they will not employ the intervention.
Colorectal cancer is the third most common cancer which strikes both women and men and the second leading cause of cancer deaths in the United States, following lung cancer. The disease is curable if a timely diagnosis is made, and it can often be found at an early stage by screening. Effective screening is possible by five modalities including colonoscopy and testing stool for blood. Just under two-thirds of the national population appropriate for screening is currently up to date on it and those in the safety net usually lag significantly behind other folks. Open Door has made an effort to improve and document screening especially in the last year and is approaching 60%, but the goal of the National Colorectal Cancer Roundtable is 80% by 2018. Screening is covered by all medical insurance and, currently, the most popular method among clinicians and patients is colonoscopy. However, it is expensive for the uninsured, is associated with very infrequent but serious complications, and some find the prospect of undergoing this procedure an unpleasant one.
Tests to detect blood in the stool have been around for many years, but the more recently employed fecal immunochemical test (FIT) is the most accurate we have had and is still relatively inexpensive, about $20-$30. It is also easier to use than earlier tests in that it requires a single sample rather than three and there are no dietary restrictions prior to testing. Whereas colonoscopy has to be repeated only every ten years if normal, it is currently believed that FIT must be repeated annually to be as good at preventing colon cancer deaths, although it is possible that biannual testing will turn out to be adequate.
The study intervention is simply a mail out of an FIT with instructions to those patients whose screening is not up to date. The control clinics will encourage screening as usual, and the additional numbers of patients who have been screened will then be compared. This will be a pragmatic trial. This means that there is no blinding and that all the clinics may try to encourage screening by any other means as long as the effort is the same in the intervention and control clinics. For example, all Open Door clinics are planning on incorporating “Flu-FIT” this next year, tying FIT screening to flu shots, and this is permitted in a pragmatic trial. As opposed to double blind randomized controlled trials done in a medical center setting, pragmatic trials attempt to accomplish important research in a real world setting. Clinics, rather than patients, are randomized in what is called a cluster randomized design and both standard and special statistical methods can be used to determine whether or not interventions are effective.
Any patient who has a positive FIT, i.e., blood detected in the stool, will be urged to undergo colonoscopy, an outpatient hospital procedure, to further evaluate for the possibility of colorectal cancer or polyps. This is because a positive stool test increases the probability of CRC from the baseline 3/1000 to about 5/100, or one out of twenty. Both St. Joseph Hospital and Mad River Community Hospital along with those physicians in our community who perform colonoscopy, gastroenterologists and general surgeons, have been supportive of this project.