The CCSIT study was a randomized community intervention trial to assess the efficacy of two different behavioral and educational counseling interventions, and a financial support intervention, in promoting CRC screening. The project utilized community-based participatory research (CBPR) methods. The study protocol was reviewed by the Community Coalition Board17
of the Morehouse School of Medicine Prevention Research Center and was approved after the Board’s suggestions were incorporated. The study was also approved by the CDC and Morehouse School of Medicine Institutional Review Boards. The Metropolitan Atlanta Coalition on Cancer Awareness (MACCA, part of the Atlanta-based National Black Leadership Initiative on Cancer) participated in recruitment as did members of the Community Coalition Board. MACCA consisted of representatives of community organizations and agencies concerned with cancer as well as unaffiliated cancer prevention advocates. Other community organizations, churches, and clinics also participated. We have shared the results of the project with these groups, and the Community Coalition Board approved this manuscript.
The eligibility criteria for this project were: African American, over age 49, no history of CRC, and no previous CRC screening test within the recommended time interval. Two full-time and one part-time community health worker (CHW) made contacts in-person at senior centers, churches, community centers, and public health clinics. The CHWs worked with MACCA and with members of the Community Coalition Board.
Eligible volunteers were invited to an introductory meeting, where they received logo gift bags containing a cookbook, message fan, pamphlets, and CRC screening information, including a National Cancer Institute (NCI)-developed pamphlet. Also included was a “Resource Directory” that included CRC screening guidelines; methods of referral for screening tests; Medicare, Medicaid, and selected insurance coverage policies; locations of sites (including low-cost sites) in metro Atlanta where screening could be obtained; transportation routes to screening sites; and free or low-cost transportation services. At this meeting, participants completed informed consent forms and pre-test questionnaires. At a second introductory meeting, participants were assigned to one of the four cohorts and, for the two educational interventions, were notified of the time and place of the next meeting. Participants were randomized by the site – church, community/senior center, or clinic at which they volunteered. That is, all participants at a given site were assigned to the same arm of the study. This prevented the “contamination” that could result from participants in different arms of the study sharing information with each other. At this second introductory meeting, the participants were also shown a slide presentation on healthy living (“Down Home Healthy Living,” tailored for African Americans).
We selected for testing three of the interventions for which the Community Guide stated that there was “Insufficient Evidence”: one-on-one education, group education, and reducing out-of-pocket costs.
One-on-One Education Cohort
A health educator met individually with participants in this group for three 45-minute sessions over three weeks to review educational materials on CRC risk and screening. All meetings took place at the recruitment site. The educational material included descriptions of CRC symptoms, diagnosis and treatment, screening tests, and screening recommendations.
Group Education Cohort
For this approach, a health educator met with participants in groups of 4 – 14 (average = 5) to review the educational material. Although the material was identical to that covered in the one-on-one counseling, there were more people at each meeting, and four sessions over four weeks were required to cover the material. Again, all meetings took place at the recruitment site.
Reduced Out-of-Pocket Expense Cohort (Financial Support)
In this group, participants were offered financial reimbursement up to $500 for out-of-pocket expenses incurred for CRC screening, including transportation and other non-medical expenses. A health educator was available to assist with negotiating direct payment and arranging transportation to the doctor’s office or medical clinic for the screening test. The health educator also provided letters of introduction and guarantee of payment for the patient to assist in scheduling the test visit.
The amount offered was more than sufficient to pay all costs involved in obtaining an FOBT, but less than half the cost of a colonoscopy. For patients seeking an endoscopic screening, the amount could cover the co-payment and/or deductable for those with private insurance or Medicare or could pay the full cost of screening at a reduced-cost public facility. Of note, the waiting list for reduced-cost screening was generally long.
Participants in this group attended the introductory session but received no intervention other than accepting the contents of the gift bag with the educational pamphlets. They received pretesting (at the introductory session), post-testing, and follow-up on a schedule identical to that of the participants in the other cohorts.
We requested medical records from the participants’ physicians or health care facilities and abstracted the records to determine whether or not each participant had, in fact, been screened for CRC prior to enrollment in the study.
The questionnaire survey (pre-test/post-test) included an assessment of knowledge, attitudes, beliefs and practices regarding general health issues and, in particular, knowledge about CRC risk and screening. Screening status for CRC was assessed by phone and/or mail at the follow-up assessment periods at 3 and, if necessary, at 6 months after the intervention.
Educational resources for the small groups and one-on-one participants included materials from the National Cancer Institute (NCI) and the American Cancer Society as well as original materials prepared for the CCSIT project. The curriculum for the educational sessions described, in lay terms, the genetics, incidence and mortality rates for CRC; disparities in detection and treatment; and the screening methods used to detect CRC. It also covered the effectiveness of diet and exercise in the prevention of CRC. Time was devoted to explaining the screening methods and relating screening to early detection and prevention of CRC. We pilot-tested all measures and procedures at a senior citizens’ center in Atlanta. Based on the experience and feedback from nine participants, the materials were refined.
Training for Personnel
One of the CCSIT investigators (S.S.) conducted training for the staff responsible for recruiting participants and conducting the interventions.
We administered the post-test questionnaires to participants in the two educational cohorts at their final intervention session; those in the control and financial groups were given their post-test questionnaires two weeks after the second introductory session. All participants were contacted by telephone approximately three months after completing their post-test questionnaires to determine whether they had been screened for CRC; if they had not been screened, they were called again at six months.
If the telephone was not answered, or if the participant was not available, at least two repeat attempts were made either by telephone or through mail. If the phone had been disconnected or the number changed, an attempt to identify a new number was made through Directory Assistance.