The following grant projects at University of Michigan have received funding from the MCC:

• Enhancement of Colorectal Cancer Screening in a Random Population Sample of Michigan Residents
  Purpose: To conduct telephone interviews and determine the nature of attitudes and practices associated with access to medical care and utilization of cancer screening and diagnostic testing in general, and also colorectal cancer screening among white and African American men and women, ages 50 to 79, in Genesee County with specific medical histories.
  Principle Investigators: David Schottenfeld, MD (e-mail: daschott@umich.edu) and Nancy Janz, PhD (e-mail: nkjanz@umich.edu)
  Publication: Janz NK, Wren PA, Schottenfeld D, Guire KE. Colorectal cancer screening attitudes and behavior: A population-based study. Preventive Medicine 37: 627-634, 2003.

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• Support for Cancer Center Network Activities (Infrastructure for Clinical Trials)
  Purpose: To develop, maintain and evaluate a Cancer Control Network to increase participation, including underserved minority populations, in clinical trials for cancer prevention, control, and treatment, and to promote the practice of guidelines-based clinical care for the treatment of breast cancer.
  Principle Investigators: Samuel M. Silver, MD, PhD (e-mail: msilver@umich.edu); Dean Brenner, MD; and Philip Stella MD (e-mail: stellap@trinity-health.org)

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• Support for Cancer Center Network with Emphasis on Underserved Populations
  Purpose: To continue the expansion of the statewide University of Michigan Cancer Center Network and, by expansion outside of the present partners, focus on recruiting underserved minority populations into cancer prevention, treatment and control trials.
  Principle Investigators: Samuel Silver, MD (e-mail: msilver@umich.edu); Phillip Stella, MD (e-mail: stellap@trinity-health.org); and Dean Brenner, MD

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• Cancer Genetics Education Project
  Purpose: To develop and evaluate a demonstration project to deliver cancer genetic education to both practitioners and clients. These activities will ultimately enhance the quality of genetic service to high-risk individuals and increase access to these services through community physicians.
  Principle Investigator: Sofia D. Merajver, MD, PhD (e-mail: smerajve@umich.edu)

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• Developing Electronic Communication-Based Interventions Between Patients and Providers to Improve Cancer Control
  Purpose: To develop and begin evaluation of tailored Web-based information programs that would allow patients to receive individually tailored information about two cancer screening initiatives, one focusing on breast cancer and one on colorectal cancer.
  Principle Investigators: Steven Katz, MD, MPH (e-mail: skatz@umich.edu) and David Stern, MD, PhD (e-mail: dstern@umich.edu)

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• Evaluating a Web-Based Tailored Information and Feedback Program to Improve Colon Cancer Screening Rates in the Primary Care Setting: A Randomized Control Trial
  Purpose: To evaluate the impact of a Web-based tailored colorectal cancer intervention, which was developed in FY 2001, on the knowledge, attitudes, intent, and behavior toward colorectal cancer screening options in a large primary care patient population through the deployment and evaluation of a randomized control trial in three large clinic sites at the University of Michigan.
  Principle Investigators: Steven Katz, MD, PhD (e-mail: skatz@umich.edu); David Stern, MD, PhD (e-mail: dstern@umich.edu); and Victor Strecher, PhD, MPH (e-mail: strecher@umich.edu)

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• Multimedia Smoking Prevention and Cessation Program for Teens
  Purpose: To 1) develop a computer-based intervention to prevent and reduce smoking among middle school students; 2) evaluate the usability and satisfaction of this new program with 7th and 9th grade students; and 3) determine the feasibility and cost of implementing such an intervention in Michigan schools.
  Principle Investigator: Unto E. Pallonen, PhD (e-mail: unto@umich.edu)

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• Testing the Effectiveness of an Internet-Based Tailored Smoking Intervention in Adolescents
  Purpose: To improve the existing expert system smoking intervention and to conduct evaluation of the Enhanced Expert system intervention by testing it in 24 schools to approximately 4,800 studentsin grades 6 and 7. This project is described as a logical continuation of the on-going research to build an effective and easily diffused Internet-based anti-smoking intervention for Michigan adolescents.
  Principle Investigator: Unto Pallonen, PhD (e-mail: unto@umich.edu)

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• Testing the Efficacy of a Web-Based Tailored Smoking Intervention in Adolescents: A Comprehensive Research and Evaluation Plan
  Purpose: To evaluate the short- and long-term effects of smoking prevention/cessation interactive self-help expert system Web-based intervention that was developed in FY 2001.
  Principle Investigators: Unto Pallonen, PhD (e-mail: unto@umich.edu) and Victor Strecher, PhD, MPH (e-mail: strecher@umich.edu)

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• Addressing the Informational Needs of Men Newly Diagnosed with Prostate Cancer in Michigan: Development of Novel Prostate Cancer Educational Interventions
  Purpose: To develop novel, patient-centered educational interventions that comprehensively educate patients about prostate cancer and its available treatments, and ultimately aid in decision-making.
  Principle Investigator: John Wei, MD, MS (e-mail: jtwei@umich.edu)

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• Testing Colorectal Cancer Screening Decision Aids
  Purpose: To 1) describe the ranges of methods or messages that people who have not been screened for colorectal cancer would find useful in changing their behavior related to such screening; 2) develop print media and Web-based messages related to promoting colorectal cancer screening; and 3) describe the range of responses to these messages and media received from the target audience with respect to ease of use, understanding, change in knowledge, change in behavior, and perceived impact on the population.
  Principle Investigator: Mack Ruffin, MD, MPH (e-mail: mruffin@umich.edu)

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• Family Assessment of Risk Evaluation (FARE) Trial
  Purpose: FARE Trial has two phases, a preparatory Phase 1 and a cluster-randomized trial Phase 2.

  Trial Phase 1 Aims:

  Aim 1: Establish a collaborative relationship with other participating centers.
  
  Aim 2: Finalize data collection instruments, family history tailored messages (FHMs) for each disease and risk group, and standard health messages (SHMs).
  
  Aim 3: Evaluate the possible participating community-based primary care practices and select the final study sites.
  
  Aim 4: Hire and train research staff.
  
  Aim 5: Select and train the final participating study site physicians.
  
  Aim 6: Finalize the recruitment process for study subjects.
  
  Aim 7: Obtain human subject approval for all participating sites.

  Trial Phase 2 Aims:

  Aim 1: To determine whether tailored FHMs increase screening for the five target diseases (primary outcome), as compared to SHMs.
  
  Aim 2: To examine the effects of FHM on: preventive health visits to clinicians; adoption of physical activity, healthy eating, and tobacco cessation; and communication about family health history.

  The target diseases are heart disease, diabetes, colorectal cancer, ovarian cancer, breast cancer, and stroke. The study is actively recruiting participants in six clinics in Michigan. Two other centers are participating in this study at Case Western Reserve Medical Center and Norwestern Medical Center in Evanston.
  
  Principle Investigator: Mack Ruffin, MD (e-mail: mruffin@umich.edu)

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• Cervical Cancer Early Detection Research Network
  Purpose: This 5-year program is funded through Interagency Agreement IA-Y1-CN-5005-01 from the National Cancer Institute to the Centers for Disease Control and Prevention to establish a Cervical Cancer Clinical Epidemiologic and Validation Center (CC-CEVC) as part of the Early Detection Research Network (EDRN). The overall goal of the network is to identify and validate molecular signatures of incipient neoplasias that can be used to improve cancer survival by specific detection of lesions at a preinvasive or early stage amenable to chemoprevention, chemotherapeutics, and curative therapy. The network will facilitate the transfer of basic science discoveries into clinical evaluation and eventual implementation. The goal of the CC-CEVC is to create a biorepository for the discovery and validation of biomarkers for early detection and risk assessment of cervical cancer. The CC-CEVC will also participate in biomarker discovery and validation using these samples.
  
  In brief, participants will be recruited from women presenting to colposcopic clinics at the University of Michigan (including sites at Wayne State University and Henry Ford Hospital System and the University of Texas Medical Branch, Galveston. The goal is for a total enrollment of 2,160 women (1,080 per site; 90 per quarter). After informed consent, women will be interviewed to collect epidemiologic data and medical history. A venepuncture will be performed. At the time of the pelvic examination exfoliated endo- and ecto-cervical cells will be collected, as well as absorbent wicks of endocervical secretions (cervical mucous). The results of the clinically indicated colposcopic examination will be recorded. The exfoliated cervical cells will be divided to yield intact methanol-fixed cells for morphologic studies, as well as total nucleic acid extracts (TNA, includes DNA and RNA) for molecular studies. A portion of the TNA will be tested for HPV using L1 consensus PCR and type-specific detection. The blood will be processed to yield serum, plasma and peripheral blood mononuclear cells (PBMC) stored for viability. The cervical secretions will be stored as frozen wicks. A chart review will be conducted to determine indication for colposcopy. Diagnostic cervical biopsies, Pap test or therapeutic cervical excisions (i.e., LEEP), will be performed as directed by the attending physician following clinical indications. Study pathologists will review all specimens related to cervical treatment or evaluation. The cervical disease status at enrollment will be determined based on the colposcopic findings, as well as the diagnostic specimens.
  
  All women will be followed every six months, or as clinically indicated, for a two year period to evaluate changes in clinical disease. Epidemiologic data collected during follow-up visits will include cervical cancer risk factor data related to the interim period. Exfoliated cells and cervical mucous samples will be collected at each visit and blood specimens at year 1 and 2 visits. Colposcopy will be performed as clinically indicated, cervical diagnosis will be determined, and therapy will be directed by the attending physician. If performed, the results of colposcopy will be recorded. All specimens (tissue and cytology) submitted to the diagnostic pathology laboratories will be reviewed by study pathologists. The cervical disease status at each visit will be determined based on clinical and pathologic findings.
  
  Principle Investigator: Mack Ruffin, MD (e-mail: mruffin@umich.edu)

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• Community Awareness, Resources and Education (CARE) - Project 3
  Purpose: CARE-Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities. Investigators from The Ohio State University Comprehensive Cancer Center and the University of Michigan have collaborated to establish a Center for Population Health and Health Disparities (CPHHD) to focus on cancer as an important health issue in underserved populations. The CPHHD has initially targeted Appalachian Ohio, a mainly rural area in southern and eastern Ohio typically associated with low income levels, high unemployment rates, and less population and economic growth than the rest of the United States. It is one of the poorest and most underserved regions in the nation.
  
  The CARE-Project 3 is one of three interrelated projects in the CPHHD funded under a grant entitled "Reducing Cervical Cancer in Appalachia (IRB # 2003C0053)" that will investigate why high rates of cervical cancer incidence and mortality are observed in Appalachian Ohio. The CPHHD currently supports the three interrelated projects and four cores established to initiate community-based participatory research within the framework of the Social Determinants of Health model.
  
  CARE-Project 3 will be conducted in 16 clinics located in four regions, which represent the general population of women aged 18 and older in Appalachian Ohio. CARE-Project 3 will utilize the CPHHD's four cores: A) Administration — fiscal and Center oversight; B) Biostatistics and Data Resources — sample selection, data management, data analysis, and population data resources; C) Clinical Correlative Sciences — collect, obtain and process biomarker specimens; and D) Behavioral Assessment and Intervention — train interviewers and lay health educators, conduct interviews, design intervention material, and facilitate communication amongst sites.
  
  This project has possible implications for rural areas of Michigan that also have high rates of invasive cervical cancer.
  
  Principle Investigator: Mack Ruffin, MD, MPH (e-mail: mruffin@umich.edu)

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last updated: 08/14/06

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