Ronald E. Myers - US grants

For some time, fecal occult blood (FOB) testing has been incorporated into a large number of colorectal cancer screening programs in the United States and internationally. In these programs, the guaiac-impregnated paper slide is the most commonly used FOB test used to detect occult stool blood. Distribution of the FOB test in colorectal cancer screening programs is predicated on the test's capacity to indicate the presence of early-stage tumors. FOB test performance in screening program target populations, however, has been disappointingly low. The proposed study is a controlled investigation of participation in a colorectal cancer screening program that is offered routinely by an individual practice association (IPA) HMO to its member population of men and women 50 or more years of age. A telephone survey of 500 men and women randomly selected from the screening program target population will be conducted initially to gather data relevant to FOB test performance. These data will include sociodemographic characteristics; health knowledge, attitudes and behaviors; past health behavior and future behavioral intent; and perceived social support. FOB test performance in two different screening program models - one based in a centralized screening office and one based in physician offices - will be analyzed. The effect of mailed and telephone reminders also will be studied. Physician support and reminders are studied in controls (n=200) and study group (n=200). Studies of participation relative to colorectal cancer screening have suffered from a variety of weaknesses, including: (1) age variance between study populations; (2) the analysis of different health behaviors and explanatory variables from study to study; and (3) failure to employ multivariate statistical techniques. As a result, few clear conclusions have been drawn regarding factors that influence participation in colorectal cancer screening programs. In the proposed study, these concerns are addressed by defining the study population by age (men and women 50 or more years of age), by specifying the behavior to be studied (FOB test performance), and by using multivariate statistical techniques in data analysis. Conclusions drawn from this study will be used to develop interventions to increase FOB test performance in populations offered occult blood testing as part of cancer screening programs.

Adherence to prostate cancer screening among older African American men, a population group at high risk for the disease, has been reported to be low. However, little is known about factors associated with adherence to screening or about effective approaches which may be used to increase screening in this high-risk group. The proposed study should result in an improved understanding of barriers to Screening among African American men and should also inform the future development and application of methods for increasing adherence to prostate cancer screening in this and other high-risk populations. The proposed three-year study will be conducted by the Fox Chase Cancer Center together with the University of Chicago Urologic-Oncology Group (UOG) and the University of Chicago Health Service (UHS). Older (50 to 70 years of age) African American men will be offered two consecutive rounds of free screening (digital rectal examination (DRE) and prostate specific antigen (PSA) testing) at a one-year interval (i.e., serial screening). Initially, 715 subjects will be identified in the UHS patient population. A telephone survey will be administered to study subjects. Overall, we estimate that 500 (70%) subjects in the sample will complete the survey. Subjects who complete the survey will be randomly assigned either to a CONTROL GROUP (N=250) or TREATMENT GROUP (N=250). Ml of these individuals will be mailed a Screening invitation letter two months after being surveyed. CONTROL GROUP subjects will receive Normal Care. A letter will be mailed which invites them to schedule an appointment for free prostate screening offered at the UOG office. Subjects who contact the UOG will be given a time, date, and location for the screening examination. Screening results will be sent to the patient and his physician. TREATMENT GROUP subjects will receive Normal Care plus a set of behavioral interventions (i.e., an educational booklet (ProRecord), an instruction telephone call (ITC), and a mailed reminder letter (RL). Adherence will be defined as undergoing DRE and PSA testing within 90 days of the date on which the screening invitation letter was mailed. Screening results will be sent to each subject and his physician. Descriptive analyses will serve to characterize study subjects in terms of sociodemographic background, medical history, risk factors, and knowledge, attitudes and beliefs (KABs) about prostate cancer and screening. Bivariate associations between these factors and adherence will be assessed. Finally, factors that are significantly associated (alpha=0.05) with adherence in will be used in multivariate analyses to identify independent predictors of adherence. As part of these analyses, the independent effect of subject exposure to the behavioral intervention will be evaluated.

DESCRIPTION: Complete diagnostic evaluation (CDE) for persons with positive results on fecal occult blood testing (FOBT plus) is a key component of colorectal cancer screening. Experts consider CDE as either colonoscopy or double air-contrast barium enema x-ray (BE) with flexible sigmoidoscopy. These procedures require primary care physician (PCP) referral(s) to gastroenterologists and colorectal surgeons and/or to radiologists. However, PCP referral for CDE is infrequent. The investigators' survey results and pilot study data indicate that PCP practice factors and PCP misperceptions about indications for CDE are likely to impact CDE referral. They propose to study PCP referral of FOBT plus patients to CDE in an established HMO-based colorectal cancer screening program that involves annual FOBT mailings to 120,000 older adults (50 years of age) in Pennsylvania and New Jersey. The study has five phases: (1) conduct a PCP focus group to elucidate CDE-related issues and barriers and convene an expert panel to develop study interventions and validate patient CDE referral status; (2) administer a baseline and endpoint telephone survey to PCPs in HMO-affiliated practices; (3) conduct a randomized, controlled trial of interventions designed to improve CDE referral and completion (Control (N is equal to 120), Intervention Group 1 (N is equal to 120), Intervention Group 2 (N is equal to 120); (4) collect CDE data from PCP surveys and forms, medical chart audit, and administrative sources; and (5) analyze intervention impact and cost-effectiveness. Control Group practices will receive usual care (i.e., the USHC Colorectal Cancer Screening Program). Intervention Group 1 practices will receive usual care plus mailed CDE reminder-feedback. Intervention Group two practices will receive usual care, mailed CDE reminder-feedback, and two CDE academic detailing outreach visits.

This application titled, Increasing Access to Clinical and Educational Studies (ACES) seeks support for the development of a cancer education and research network developed to facilitate the development of new cancer prevention and control research grant applications that are culturally appropriate to minority populations in Philadelphia and feasible for implementation in community-based primary care practices that serve minority populations members. The network will link cancer researchers, community health care leaders, community-based nurses, community- based primary care practices, and cooperative oncology groups. This effort will expand a cancer research partnership that was formed in 1996 between the Kimmel Cancer Center (KCC) of Thomas Jefferson University (TJU) and Philadelphia community health care leaders. Specific aims of the application are to: (1) Organize a cancer education and research network in Philadelphia. (2) Recruit minority scientists who have the potential to become co- investigators on pilot studies and to develop investigator- initiated grant applications. (3) Provide education about cancer prevention and control through African American churches. (5) Submit new research grant applications that are designed to increase the participation of African Americans in cancer prevention and control research. In Phase 1 of the ACES Project, a steering committee and three disease site-specific (i.e., breast, colorectal, and prostate cancer) working groups will be organized. During Phase 2 of the project, community cancer education efforts and at least three pilot studies will be initiated. It is anticipated that these studies will assess methods for encouraging the informed use of cancer prevention and control modalities and participation in cooperative group trials among African Americans who reside in West Philadelphia and North Philadelphia. In Phase 3, we will prepare and submit new research grant applications based on results from the pilot studies.

ABSTRACT=The American Cancer Society recommends that men and women 50 or more years of age have a annual fecal occult blood test (FOBT) and a flexible sigmoidoscopy (FS) examination every five years to screen for colorectal cancer (CRC). Alternative CRC screening regimens that are recommended include having a barium enema X-ray (BE) at five- year intervals or a colonoscopy (CX) every 10 years. Compliance with CRC screening guidelines is low. The proposed study, Increasing Colon Cancer Screening in Primary Care, is intended to develop and test methods that may be used to increase CRC screening compliance. Study participants will be male and female patients of a large, urban primary care practice (Jefferson Family Medicine Associates), who are 50 to 74 years of age and are at average risk for CRC according to American Cancer Society guidelines. After a Baseline Survey and Baseline Chart Audit are completed, 1,488 study participants will be randomly assigned either to a Control Group, a Standard Intervention (SI) Group, a Tailored Intervention (TI) Group, or a Tailored Intervention plus Phone (TIP) Group. During a two-year period, the Control Group will receive usual care, while the intervention groups will be provided two annual screening interventions. The SI Group will receive a standard CRC screening invitation letter, a CRC screening kit (an educational booklet, and an educational videotape, and FOBTs), and a standard reminder letter. The TI Group will receive a tailored CRC screening invitation letter, a CRC screening kit, and a tailored reminder letter. Here, educational messages tailored to participant stage of decision making about screening will be embedded in the letters. The TIP Group will receive the same intervention at the TI Group, plus a tailored telephone counseling call to amplify educational messages in the tailored screening invitation letter. Midpoint and Endpoint Surveys will be administered and an Endpoint Chart Audit will be completed for study (participants. Specific aims of the study include the following: (1) Assess the impact of study interventions on screening compliance. (2) Assess the impact of study interventions on screening decision-making stage. (3) Assess the impact of study interventions on defined cognitive and psychosocial variables. (4) Identify variables associated with screening compliance and decision-making stage. (5) Evaluate intervention cost- effectiveness relative to screening compliance.

DESCRIPTION (provided by applicant) Screening can reduce the colorectal cancer (CRC) burden but remains underutilized in primary care. In the proposed study, tailored messaging will be used to encourage FOBT and endoscopic screening in 14 primary care practices that are part of the Christiana Care Health System in Delaware. Using a quasi-experimental pretest-posttest design, we will deliver a Tailored Screening Intervention or TSI (a tailored screening kit, a tailored telephone call, and a tailored reminder letter) to patients who complete a Baseline Survey. Participants will be sent a kit containing a tailored CRC screening invitation letter and two tailored message pages that reflect their perceptions about screening FOBT and flexible sigrnoidoscopy and screening decision stage. An informational booklet on CRC screening and FOBT cards with instructions will also be included. A trained nurse educator will deliver a tailored telephone call to patients 10 days after the kit is mailed. During the call, the nurse educator will confirm receipt of mailed materials, verify current decision stage, review deliver tailored messages, determine current decision stage, encourage positive movement in decision stage, provide tailored messages keyed to decision stage, explain steps involved in FOBT and endoscopy screening, and offer to schedule endoscopy screening. For patients who do not report that they have decided to screen, the nurse educator will recommend that they discuss screening with their primary care physician. At 30 days, a tailored reminder letter will be sent to patients who have not screened or who have not scheduled screening and to their primary physician. The letter will provide current tailored messages, encourage positive movement in decision stage, and suggest physician-patient discussion of screening. An Endpoint Survey will be administered and an Endpoint Chart Audit will be conducted. Primary study aims are to: 1. Determine intervention impact on CRC screening utilization, 2. Determine intervention impact on screening decision stage, and 3. Determine intervention impact on patient perceptions about screening.

DESCRIPTION (provided by applicant): The proposed project represents an exciting opportunity to engage older urban African Americans in a comparative effectiveness study of methods to increase CRC screening. African American participants represent only about 25% of study participants in the parent study. As a result, we will not be able to determine the impact of different intervention methods in this high-risk group. Determining how to increase CRC screening among African Americans will help to reduce disparities in disease incidence and mortality. In this competitive revision, the patient population for the study will be drawn from Einstein Health System primary care practices in Philadelphia that serve a predominantly African American patient population. Using a two-group randomized design, we will randomly assign consenting participants who complete a baseline telephone survey (N=472) to either a Standard Intervention (SI) Group (N=236) or an Enhanced Tailored Navigation Intervention (E-TNI) Group (N=236). SI Group participants will receive a generic mailed intervention that encourages CRC screening. E-TNI Group participants will receive a mailed intervention that is culturally-targeted to African Americans, telephone contacts, and electronic communications intended to encourage CRC screening. Specific aims of the study, in order of priority, are to determine (1) E-TNI impact on CRC screening utilization, (2) E-TNI impact on CRC screening preference, and (3) E-TNI impact on perceptions about CRC screening. We hypothesize that the E-TNI Group will have significantly higher CRC screening use, increased preference for CRC screening, and more favorable perceptions about CRC screening than the SI Group. Data obtained from an endpoint survey and an endpoint chart audit will be used to assess study group differences. PUBLIC HEALTH RELEVANCE: The proposed competitive revision represents an exciting opportunity to engage older urban African Americans in a comparative effectiveness study of methods to increase CRC screening. Determining how to increase CRC screening among African Americans will help to reduce disparities in disease incidence and mortality.