A Feasibility Study about Increasing Colon Cancer Screening:

1. A Feasibility Study about Increasing Colon Cancer Screening:  How to Say “Yes” Even to the Uninsured and Under-insured Colon cancer is: # 2 cause of cancer death in the U.S. Preventable by removing pre-cancerous polyps, often found during a colonoscopy procedure, detected by endoscopy Highly treatable – if found early Participation in colon cancer screening is lower than for breast, cervical, and even prostate cancer. This pilot study explores an intervention strategy to increase CRC screening among the uninsured and under-insured in a predominantly African American community. Colon cancer is: # 2 cause of cancer death in the U.S. Preventable by removing pre-cancerous polyps, often found during a colonoscopy procedure, detected by endoscopy Highly treatable – if found early Participation in colon cancer screening is lower than for breast, cervical, and even prostate cancer. This pilot study explores an intervention strategy to increase CRC screening among the uninsured and under-insured in a predominantly African American community.

2. Test feasibility of implementing a CRC screening program in different venues that serve under and uninsured patients What are participation rates? Is a re-packaged stool test – to make instructions easier to follow – associated with a higher screening rate? Project Goal: Test the feasibility of implementing a community-based CRC screening intervention using a fecal immunochemical test, or FIT. FIT is a type of stool test. There are many brands on the market. This study used a 3-sample test manufactured by Beckman Coulter called the Hemoccult ICT. This test is similar to FOBT (fecal occult blood test); however it does not require dietary restrictions and it is believed to have a higher sensitivity, as well as good specificity. Three organizations distributed the FIT concurrently with a screening recommendation to their age and risk-eligible clients or patients. Research questions included: For this screening intervention, what is the reach and participation rate at different community sites or venues? Could we reliably muster resources to provide timely diagnostic follow-up and treatment for study participants who had a positive result? Is redesigned packaging for this stool test – based on focus group data – associated with an improved return rate? Project Goal: Test the feasibility of implementing a community-based CRC screening intervention using a fecal immunochemical test, or FIT. FIT is a type of stool test. There are many brands on the market. This study used a 3-sample test manufactured by Beckman Coulter called the Hemoccult ICT. This test is similar to FOBT (fecal occult blood test); however it does not require dietary restrictions and it is believed to have a higher sensitivity, as well as good specificity. Three organizations distributed the FIT concurrently with a screening recommendation to their age and risk-eligible clients or patients. Research questions included: For this screening intervention, what is the reach and participation rate at different community sites or venues? Could we reliably muster resources to provide timely diagnostic follow-up and treatment for study participants who had a positive result? Is redesigned packaging for this stool test – based on focus group data – associated with an improved return rate?

3. Academic-Community PartnershipGoals Increase adoption of CRC screening among: The uninsured and under insured African Americans Implement and evaluate a sustainable intervention that integrates: Best research evidence Professional expertise Preferences expressed by people in community and practice settings Study was initiated and developed through a partnership between researchers at UNC Chapel Hill and cancer prevention and control planners and health advocates in High Point, NC. Our goal included launching and evaluating an intervention that could be sustained after funding ended. We felt the likelihood of developing a sustainable program would be enhanced if it incorporated the best research evidence, professional advice of our local partners, and also incorporated preferences that community members had shared in focus groups and in community meetings. Study was initiated and developed through a partnership between researchers at UNC Chapel Hill and cancer prevention and control planners and health advocates in High Point, NC. Our goal included launching and evaluating an intervention that could be sustained after funding ended. We felt the likelihood of developing a sustainable program would be enhanced if it incorporated the best research evidence, professional advice of our local partners, and also incorporated preferences that community members had shared in focus groups and in community meetings.

4. Academic-Community PartnershipIntervention Planning Convened participatory planning meetings and “report backs” in the community Reviewed evidence Conducted community assessment, including focus groups Planning spanned nearly a year: It included community planning meetings and “report backs” to the community – using in-person sessions and newsletters. reviewing the evidence, particularly The Community Guide for Preventive Services and colon cancer screening recommendations from professional and advocacy organizations. Community assessment, including an inventory of public health and health care resources for CRC prevention, control, and treatment and focus groups with members of the community we were most concerned about reaching (African Americans who were not up-to-date for screening and were under-insured or uninsured). Difficult questions emerged during the planning process: The evidence-base for CRC screening and early detection is growing fast and, therefore, hard to synthesize. New data are released – almost daily – about the effectiveness of available tests, new screening technology, recommended intervals for screening, and the comparative cost-benefits of various tests. Systematic reviews in The Community Guide for Preventive Services tells us what intervention strategies are likely to be effective, but the recommendations are not always based on the most current research, and details about how to implement recommendations is missing. Are there enough endoscopists to meet increased demand? Who will pay for their services? Planning spanned nearly a year: It included community planning meetings and “report backs” to the community – using in-person sessions and newsletters. reviewing the evidence, particularly The Community Guide for Preventive Services and colon cancer screening recommendations from professional and advocacy organizations. Community assessment, including an inventory of public health and health care resources for CRC prevention, control, and treatment and focus groups with members of the community we were most concerned about reaching (African Americans who were not up-to-date for screening and were under-insured or uninsured). Difficult questions emerged during the planning process: The evidence-base for CRC screening and early detection is growing fast and, therefore, hard to synthesize. New data are released – almost daily – about the effectiveness of available tests, new screening technology, recommended intervals for screening, and the comparative cost-benefits of various tests. Systematic reviews in The Community Guide for Preventive Services tells us what intervention strategies are likely to be effective, but the recommendations are not always based on the most current research, and details about how to implement recommendations is missing. Are there enough endoscopists to meet increased demand? Who will pay for their services?

5. Evidence -USPSTF Screening Guidelines For average risk adults 50 years or older: Stool test -- fecal occult blood test (FOBT) or fecal immunochemical test (FIT), annually* flexible sigmoidoscopy every five years FOBT or FIT plus flexible sigmoidoscopy every 5 years double-contrast barium enema every five years colonoscopy every 10 years * multiple sample FOBT/FIT should be used US Preventive Services Task Force recommendations were a primary source for deciding which screening strategy to use in our intervention targeting age-appropriate people who are at average risk for CRC. All of the USPSTF-recommended screening strategies are effective for increasing early detection and reducing mortality, with none showing clear advantages for reducing mortality. The academic/community partnership team selected a 3-sample FIT, manuractured by Beckman Coulter (Hemoccult ICT). Although other, more convenient 1 and 2 sample FIT were on the market, guidelines continue to recommend a multi-day test (polyps may bleed intermittently). Also, anecdotal evidence suggested that some of the other FITs produce a higher rate of false positives. One goal of our intervention was to reduce the number of average risk people needing referral to endoscopy services due to false positive results. US Preventive Services Task Force recommendations were a primary source for deciding which screening strategy to use in our intervention targeting age-appropriate people who are at average risk for CRC. All of the USPSTF-recommended screening strategies are effective for increasing early detection and reducing mortality, with none showing clear advantages for reducing mortality. The academic/community partnership team selected a 3-sample FIT, manuractured by Beckman Coulter (Hemoccult ICT). Although other, more convenient 1 and 2 sample FIT were on the market, guidelines continue to recommend a multi-day test (polyps may bleed intermittently). Also, anecdotal evidence suggested that some of the other FITs produce a higher rate of false positives. One goal of our intervention was to reduce the number of average risk people needing referral to endoscopy services due to false positive results.

6. Evidence - The Guide to Community Preventive Services The Community Guide recommends the following client-directed interventions for CRC screening: Client reminders Reducing structural barriers Small media Reducing out-of-pocket costs One-on-one education According to the Community Guide for Preventive Services, the following 5 client-directed intervention strategies have been proven to be effective. To the extent possible, we wanted to develop a screening program that incorporated the evidence-base. According to the Community Guide for Preventive Services, the following 5 client-directed intervention strategies have been proven to be effective. To the extent possible, we wanted to develop a screening program that incorporated the evidence-base.

7. The Intervention Provide CRC screening recommendation and FIT at: 2 “free” clinics 1 organization also distributed FIT at community health events and its wellness clinics Package FIT as a small media intervention based on focus group data The intervention, included: : Increased access-- for average-risk individuals 50 years and older -- to a CRC screening recommendation and an actual FIT kit FIT kits were distributed at 2 free or low-cost clinics a 3rd site -- a community outreach and health organization -- also distributed the kits at selected health fairs and community events, as well as in their wellness clinic Based on focus group data, the kits were repackaged as a small media intervention: increased font; added images to illustrate each step of the stool test process; aligned and bundled the materials to makes the steps easier to follow. Distribution sites were responsible for notifying patients of FIT results and referring patients to diagnostic colonoscopy if needed. Income-eligible patients were able access free diagnostic services through collaborative agreements with a local GI practice and hospital.The intervention, included: : Increased access-- for average-risk individuals 50 years and older -- to a CRC screening recommendation and an actual FIT kit FIT kits were distributed at 2 free or low-cost clinics a 3rd site -- a community outreach and health organization -- also distributed the kits at selected health fairs and community events, as well as in their wellness clinic Based on focus group data, the kits were repackaged as a small media intervention: increased font; added images to illustrate each step of the stool test process; aligned and bundled the materials to makes the steps easier to follow. Distribution sites were responsible for notifying patients of FIT results and referring patients to diagnostic colonoscopy if needed. Income-eligible patients were able access free diagnostic services through collaborative agreements with a local GI practice and hospital.

8. Methods -Data Collection, Outcomes Unique participant ID Self-administered, brief demographic questionnaire Data tracking logs maintained as part of the patient record Enrollment site (Site A, B, C) Fit Returned: Yes/No Dates: Participant receives FIT Lab receives completed FIT Participant notified of test results Endoscopy referral data Endoscopy completion date At enrollment, A research assistant assigned a unique ID number to each FIT Kit to permit tracking through the screening program. Each participant completed a brief demographic questionnaire. Each site maintained FIT tracking logs.At enrollment, A research assistant assigned a unique ID number to each FIT Kit to permit tracking through the screening program. Each participant completed a brief demographic questionnaire. Each site maintained FIT tracking logs.

9. Methods -Sample Three enrollment and screening sites Clinic for uninsured: below 100% FPG Clinic for under and uninsured: below 250% FPG Community-based organization: added health events to its clinic distribution program Participant eligibility criteria 50 years or older Not up-to-date for screening No personal or family history of CRC or polyps Asymptomatic The 3 distribution sites were identified by our community partners and also in 4 focus groups conducted as formative research for this pilot. Representatives from each of these sites became members of the planning group. Two “free” clinics served slightly different populations based on income and insurance guidelines. One community-based organization that has been engaged in minority health promotion and health advocacy for 30+ years and has a distinguished record of community outreach and engagement. Eligibility criteria match USPSTF screening recommendations for average risk individuals.The 3 distribution sites were identified by our community partners and also in 4 focus groups conducted as formative research for this pilot. Representatives from each of these sites became members of the planning group. Two “free” clinics served slightly different populations based on income and insurance guidelines. One community-based organization that has been engaged in minority health promotion and health advocacy for 30+ years and has a distinguished record of community outreach and engagement. Eligibility criteria match USPSTF screening recommendations for average risk individuals.

10. Methods -Sample: Aim 1 AIM 1. Test feasibility of implementing a CRC screening program in different venues that serve under and uninsured patients Enrolled: 203 Total approached: 1167 Refused: 50 (19.8%) Aim 1: test the feasibility of implementing this FIT screening program through different venues. Over the period of 1 almost one year, 203 enrolled, a small percentage of approximately 1167 people approached. Refusal rate was less than 20% (50 out of 253 eligible people refused). Number of ineligibles was much higher than expected – 914 people or 78% of those approached. Reasons for exclusion were: Symptomatic: 4% Personal or family history of polyps or cancer: 25%. Unfortunately, these two groups are reported in aggregate. A higher percentage than expected said they were up-to-date for screening. An important limitation of this study is inadequate documentation of non-participants and their reasons for not participating. Cancer control planners need better data to develop CRC screening risk profiles. This should be an important goal of future research.Aim 1: test the feasibility of implementing this FIT screening program through different venues. Over the period of 1 almost one year, 203 enrolled, a small percentage of approximately 1167 people approached. Refusal rate was less than 20% (50 out of 253 eligible people refused). Number of ineligibles was much higher than expected – 914 people or 78% of those approached. Reasons for exclusion were: Symptomatic: 4% Personal or family history of polyps or cancer: 25%. Unfortunately, these two groups are reported in aggregate. A higher percentage than expected said they were up-to-date for screening. An important limitation of this study is inadequate documentation of non-participants and their reasons for not participating. Cancer control planners need better data to develop CRC screening risk profiles. This should be an important goal of future research.

11. Results: Aim 1 Respondent Characteristics Mean age 57.5 years Male 42% African American 61% Income Less than $15,000 80% Less than $5,000 34% Insurance Status No insurance 60% Has Medicare/Medicaid 28% Has regular provider 86% Successfully reached the target population. A high percentage reported having a regular provider. These are primarily patients of the two free clinics.Successfully reached the target population. A high percentage reported having a regular provider. These are primarily patients of the two free clinics.

12. Results: Aim 1FIT Return Rates by Site  Overall, 66% completed the FIT Sites A-B – the two clinics -- both had FIT return or screening rates of 74%. Site C – used outreach strategies, primarily, to enroll patients into the screening program. Clients of this agency were also more likely to be male and less likely to report having a regular health care provider. FIT completion rates of 74% at Sites A and B indicate that some types of free clinics can play an important role in closing the screening gap and early detection gap for the insured and uninsured. Under and uninsured may be more willing to use to FOBT or FIT screening than previously assumed by health care providers and cancer prevention and control planners. Overall, 66% completed the FIT Sites A-B – the two clinics -- both had FIT return or screening rates of 74%. Site C – used outreach strategies, primarily, to enroll patients into the screening program. Clients of this agency were also more likely to be male and less likely to report having a regular health care provider. FIT completion rates of 74% at Sites A and B indicate that some types of free clinics can play an important role in closing the screening gap and early detection gap for the insured and uninsured. Under and uninsured may be more willing to use to FOBT or FIT screening than previously assumed by health care providers and cancer prevention and control planners.

13. Results: Aim 1Diagnostic Screening Referrals  4 Positive FIT results 3 completed colonoscopy 1 not yet followed through on referral Polyps found and removed in all three patients.

14. Methods: Aim 2 RCT to Measure Differences in FIT Use Is a re-packaged stool test – designed to make instructions easier to follow – associated with a higher screening rate? Aim 2: RCT to test whether a redesigned kit was associated with an increased screening rate. Redesigned kit: Added persuasive messages about colon cancer risk and screening benefits Increased font size Made images larger and clearer Aligned and bundled stool sampling materials to make each step easier to follow Made toll-free number to call for help or information more prominent Only patients at sites A and B (the two clinics with 74% return rates) were enrolled into the RCT. The goal was to enroll 100 patients into each arm: Intervention: redesigned kit (participants were subset of feasibility study sample) Control: a “usual care” kit (participants were newly recruited) RCT eligibility criteria was same as for the feasibility study. Aim 2: RCT to test whether a redesigned kit was associated with an increased screening rate. Redesigned kit: Added persuasive messages about colon cancer risk and screening benefits Increased font size Made images larger and clearer Aligned and bundled stool sampling materials to make each step easier to follow Made toll-free number to call for help or information more prominent Only patients at sites A and B (the two clinics with 74% return rates) were enrolled into the RCT. The goal was to enroll 100 patients into each arm: Intervention: redesigned kit (participants were subset of feasibility study sample) Control: a “usual care” kit (participants were newly recruited) RCT eligibility criteria was same as for the feasibility study.

15. Aim 2RCT Sample Enrolled: 198 patients At the 2 clinics Intervention kit (n=102) Usual care FIT kit (n=96) Usual care kit was a biohazard baggie containing 3 FIT cards, 3 sample sticks, and 3 latex gloves. This is the FIT kit already in use at one of the two free clinic sites. The other clinic had not previously provided stool tests to their patients. Usual care kit was a biohazard baggie containing 3 FIT cards, 3 sample sticks, and 3 latex gloves. This is the FIT kit already in use at one of the two free clinic sites. The other clinic had not previously provided stool tests to their patients.

16. No statistically significant difference in the return rates, overall or by race. A study with greater statistical power might be able to help us determine whether the redesigned kit can help erase the gap in return rates between African Americans and Whites. (See pair of middle bars.)No statistically significant difference in the return rates, overall or by race. A study with greater statistical power might be able to help us determine whether the redesigned kit can help erase the gap in return rates between African Americans and Whites. (See pair of middle bars.)

17. Conclusions and Summary Patients seen at typical “free clinics” will accept and use FIT (74%). Alternative screening sites (e.g., community-based screening events) less effective for CRC screening promotion (39%). Offering annual FIT screening to average risk, age-appropriate patients did not exceed capacity of local endoscopy providers to donate diagnostic follow-up. Still unsure if packaging improvements/small media can increase FIT screening rate in some populations. The effect of packaging and small media interventions may be modest or nonexistent; however, merely recommending FIT screening and making the test easily available to patients at free clinics is likely to have a positive effect on screening rates. Assurance of appropriate follow-up in the case of a positive result is also critical. This screening intervention did not overwhelm the capacity of a small local endoscopy practice to donate services at no charge. The effect of packaging and small media interventions may be modest or nonexistent; however, merely recommending FIT screening and making the test easily available to patients at free clinics is likely to have a positive effect on screening rates. Assurance of appropriate follow-up in the case of a positive result is also critical. This screening intervention did not overwhelm the capacity of a small local endoscopy practice to donate services at no charge.

18. Acknowledgements Members of the Greensboro CRC Screening Planning Group: Gordon Cole, Merle Green, Carin Hiott, Kim Lookabill, Kathy Norcott, Kathy Reid, Walter Shepherd, Greg Taylor, Cindy Toler, Brandolyn White and Jerri White Adult Health Center, High Point Regional Health System Beckman Coulter, Inc Carolina Community Network staff and faculty, with special thanks to Brandolyn White, Crystal Meyer and Paul Godley CHAI Core, UNC-Chapel Hill Community Clinic of High Point UNC Program on Ethnicity, Cornerstone Gastroenterology Guilford County Department of Public Health Greensboro Community Research Advisory Board High Point Regional Health System David Farrell at People Designs Piedmont Health Services and Sickle Cell Agency Washington Colon Health Program