Currently Funded Research Projects
Here are some of the currently funded research projects that mentors are working on, divided into the following research areas: (1) Improving Quality of Life (QOL) and Increasing Survival; (2) Tobacco Control; and (3) Early Detection.
Improving Quality of Life (QOL) and Increasing Survival
- “Menstrual Cycle Maintenance and Quality of Life Following Treatment for Breast Cancer: A Prospective Study” (DOD; PI: Michelle Naughton). This is a continuation and expansion of a previous DOD grant begun in 1996 to study menstrual cycle patterns following treatment for breast cancer. To our knowledge, this is the largest prospective study (N=836) in the world to determine the impact of breast cancer treatment on menstrual bleeding/amenorrhea and subsequent fertility, as well as a wide variety of QOL issues. The goals of this multi-center study are: (1) to track the menstrual bleeding of premenopausal women who received adjuvant chemotherapy for breast cancer to determine factors associated with the continuation of menses or amenorrhea, (2) to track any subsequent pregnancies and their outcomes, and (3) to study the impact of a breast cancer diagnosis and treatment on QOL.
- “Investigating Mechanisms to Explain Age Associated Differences in Quality of Life among Breast Cancer Patients” (DOD; PI: Nancy Avis) was designed to better understand why younger women have greater psychological morbidity following a breast cancer diagnosis than older women. Considerable research has shown that younger women have a more difficult time adjusting to a breast cancer diagnosis. The unanswered research question has been whether this is due to more aggressive treatment received by younger women or the greater impact on their lives. This prospective observational cohort study examines detailed treatment and tumor characteristics, personal resources (e.g., social support, coping strategies, resiliency), and the impact of cancer on life roles and responsibilities on QOL (illness intrusiveness). A total of 658 women were recruited and followed up to 24 months post diagnosis.
- “Research on Optimal Recovery Practices in Breast Cancer (RESTORE)” (DOD: PIs: Shannon Mihalko, Roger Anderson). The objective of this study is to improve the QOL and reduce lymphedema among breast cancer survivors with and exercise intervention. The study randomized 104 patients to one of two study arms (exercise vs. patient education); 82 participants completed the 18 month follow-up period. Women in the treatment group began a center-based exercise and lymphedema education program 2-3 days per week gradually shifting to the home. Controls received patient education.
- “Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes” (R21 AT004234; PI: Nancy Avis, Co-PI: Suzanne Danhauer). A developing area of survivorship research is the use of complementary/integrative therapies for symptom management, which could significantly improve QOL among cancer survivors. Hot flashes are particularly problematic, because the most effective treatment, hormone therapy, is contraindicated for survivors of hormone-dependent cancers. This project evaluates the effectiveness of yoga as an intervention for treating hot flashes. This study is randomly assigning women to yoga or health and wellness classes to examine the impact on both objective and subjective hot flashes. Additional funding was received as part of ARRA funds to add salivary cortisol and heart rate variability measures.
- “Yoga during breast cancer treatment: Establishing Community-Based partnerships” (TSI scholar award; PI: Suzanne Danhauer). This project involves translating yoga research from an academic cancer center to community partners in the CCOP Research Base. Newly diagnosed breast cancer patients are being randomized to a yoga or health and wellness group with the intervention being delivered at community cancer centers. Primary outcomes include fatigue, mood, and health-related quality of life.
- “The Nutrition, Exercise and Weight Management Lifestyle” project (R25 CA117887 PI: John Spangler). This project is developing, implementing and evaluating a medical school curriculum spanning all four undergraduate medical education years to teach students skills in culturally competent weight management counseling. Students will be instructed in basic and clinical sciences related to nutrition, exercise and weight management; will interact with standardized patient instructors to counsel on weight management; and will be evaluated. Two educational web modules have been designed and are now being pilot-tested for the class of 2012. These modules, Epidemiology of Obesity and Obesity and Cancer: The Evidence, will be implemented as educational materials for M1 students during their first year epidemiology course. The focus of all materials will be not only on weight management, but also on weight, nutrition and exercise as these relate to cancer prevention.
- “Long-term Survivorship in Older Women with Early Stage Breast Cancer” (BOW-2; PI: Ann Geiger). The specific aims of this follow-up grant are: (1) To determine whether surveillance mammography beyond 5 years following diagnosis reduces breast cancer-specific mortality, and explore whether surveillance mammography is cost-effective. (2) To determine the cost-effectiveness of standard primary tumor therapy (breast conserving surgery [BCS] followed by radiation therapy or mastectomy) and adjuvant (tamoxifen) therapy, compared with less-than-standard therapy, for older women with breast cancer. (3) To identify late effects of breast cancer and its treatment by comparing incident comorbidity in 5-year breast cancer survivors to a matched comparison cohort without breast cancer.
- “Paricalcitol for Palliation in Advanced Prostate Cancer: A Phase II Trial” (PI: Gary Schwartz) This is a Phase II clinical trial in men with androgen-insensitive prostate cancer who have bony metastases and who have significantly elevated serum PTH. A 19-nor-1,25-Dihydroxyvitamin D2 (paricalcitol capsule), an oral vitamin D analogue that is FDA-approved is being used to suppress serum PTH. We have previously shown that this drug inhibits the progression of prostate cancer cells in vitro. This research represents a translation of our laboratory work to an investigator-initiated extramurally-funded, clinical trial. We will treat 30 men for 16 weeks and suppress serum PTH levels to =50% of its baseline values. The Specific Aims are to: 1) Test the hypothesis that medical suppression of serum PTH in men with metastatic prostate cancer will result in a decrease in bone pain, a reduction in use of analgesic medications, and improved quality of life. 2.) Test the hypothesis that subjective changes in bone pain and improved quality of life will be associated with objective changes in bony remodeling, as assessed by biochemical markers of bone resorption and bone formation. 3) Use these data to plan a blinded, placebo-controlled Phase III trial of paricalcitol in pain reduction and quality of life in metastatic prostate cancer.
- “Colon Cancer Treatment, Surveillance, and Survival among the Poor” (PI: Ann Geiger). This project evaluated the patient, health services, and community characteristics that affect colorectal cancer treatment and surveillance. The study included Medicaid and Medicare claims, NC Central Cancer Registry, US Census, and Death Index databases from Medicaid enrollees from 1998 to 2002 (n=2233). Treatment guidelines from the NCCN were used to define guideline-consistent treatment and post-treatment surveillance. All cause and cancer-specific mortality covered 10 years (1998 to 2007). Results show that for chemotherapy and surveillance, findings are very consistent in that age overwhelmingly appears to explain variation in treatment, with older patients being undertreated and undersurveilled, even if they have no comorbid conditions. The study is meant to generate hypotheses for future interventions at the patient, system, and community levels to reduce colon cancer treatment, surveillance, and survival among the poor.
- “Breast Cancer Treatment Effectiveness in Older Women” (PI: Rebecca A. Silliman, Boston Medical Center). The focus of this project is to analyze the effectiveness of primary and adjuvant therapies in preventing recurrence and death in women diagnosed with breast cancer at age 65 years and older, a group understudied in the clinical trials setting and in whom therapy options are complicated by comorbidities. This study is based in the NCI-funded HMO Cancer Research Network, in which automated data on large and diverse populations provide a unique opportunity for treatment effectiveness studies. By continuing to follow the existing cohort of women through 15 years after diagnosis and incorporating a comparison cohort, they aim to determine: (1) whether surveillance mammography beyond five years after diagnosis reduces breast cancer-specific mortality, and explore whether surveillance mammography is cost-effective; (2) determine the cost-effectiveness and standard primary tumor therapy; and (3) identify late effects of breast cancer and its treatment.
- “Quality of care in older breast cancer survivors” (CA093772; PI on subcontract Ann Geiger)
- “A Feasibility Study of a Physical Activity Intervention in Older Adults with Acute Leukemia.” (PIs: Shannon Mihalko, Suzanne Danhauer, Heidi Klepin) This multidisciplinary project extends the findings from the RESTORE project on exercise for breast cancer survivors to a population of acute leukemia patients. The primary and secondary objectives of this study are as follows: To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy. Secondarily, to obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.
- “Measuring Student Exposure to ETS and College Receptivity to Environment Change” (5R21CA131749-02; PIs: Mark Wolfson and Erin Sutfin). The goal of this research is to inform the development of a randomized campus/community trial to reduce college student smoking and exposure to secondhand smoke. The first specific aim of this project is to collect and analyze data that will inform the design of the intervention approach for the trial. To achieve this aim, the investigators developed and implemented a web-based survey of college administrators from 152 colleges and universities in the Southeastern United States. Data from this survey are currently being analyzed and dissemination efforts have begun. Study team members have also conducted in-person interviews with a smaller sample of campus administrators. This resulted in 42 interviews, all of which are currently being analyzed using NVivo qualitative data analysis software. Results from the survey and interviews will provide insight as to how to frame the problem to college administrators, identify criteria on which to select schools to be included in the trial, and identify policies and practices that college administrators may be willing to implement on their campus. The second specific aim is to develop methods for the systematic assessment of exposure to secondhand smoke among college students. Two methods are to be used to measure air quality. The first is personal air monitoring, which involved continuous measurement of air quality over a four-day period by a sample of 42 college students. Data analyses are currently underway. The second approach, microenvironment indoor air quality monitoring, involves measuring air quality in specific venues in and around the college campus that are likely to be populated by college students.
- “Smokeless Tobacco Use in College Students” (1R01CA141643-01; Co-PIs: Drs. Mark Wolfson and John Spangler). Smokeless tobacco products contain nicotine, are highly addictive, and contain many cancer causing chemicals. The tobacco industry targets college aged students to use these products. The goal of this project is to more fully understand patterns of smokeless tobacco use among college students by repeated surveys of students at 10 colleges over their four years of college and assessments of campus and community policies related to smokeless tobacco use, point-of-purchase advertising and sales, and promotional events in local bars. There are 3 specific aims: Aim 1: To measure trajectories of SLT use among undergraduate college students over the course of their college careers. Aim 2: To identify environmental and individual-level correlates of trajectories of SLT use and Aim 3: To examine patterns of use of different SLT products, including chewing tobacco, dry and moist snuff (including snus and other flavored products), and alternative products (including lozenges, strips, orbs, and sticks).
- “Implementation and Dissemination of Evidence-Based Tobacco Cessation Strategies in Free Clinics for the Uninsured: A Pilot Study” (1R21DA024631-01; PI: Erin Sutfin) The goal of this study is to implement and disseminate evidence-based tobacco cessation strategies in free clinics that serve the uninsured, to reduce tobacco use among this at-risk population. Individuals without health insurance are 1½ times more likely to smoke than those insured through private providers and are less likely to receive smoking cessation advice from a health professional. The goal of this research is to provide formative data on the implementation and dissemination of evidence-based tobacco cessation strategies in free clinics by achieving the following aims: (1) increasing free clinics’ organizational readiness to adopt the United States Public Health Service’s Guidelines on Treating Tobacco Use and Dependence; (2) evaluating the efficacy of the evidence-based strategies in promoting tobacco cessation behaviors among the clinics’ health care volunteers and uninsured patients; and (3)testing whether the North Carolina Association of Free Clinics has the capacity to disseminate the evidence-based tobacco prevention and cessation strategies in absence of the university research team. These aims will be accomplished through a randomized, controlled trial design to test the adoption, efficacy, and dissemination of clinic-based tobacco cessation strategies in six free clinics. These aims will be evaluated using three data collection protocols including key informant interviews, environmental scans, and patient exit interviews.
- “Building Capacity for Tobacco Research in Hungary” (Fogarty/NCI R01 TW007927; PI: Kristie Foley; Co-Is: Easterling, Spangler, Wolfson) (Subcontract to Wake Forest University Health Sciences; Consortium PI: Doug Easterling). This research and capacity building project aims to: (1) create institutional capacity that will support scientists in carrying out tobacco research and in translating research findings into programs and policies to reduce tobacco use; (2) conduct mentored research that has the potential to significantly reduce tobacco use at the local and national level; and (3) build individual capacity among Hungarian and U.S. research partners. The project has engaged 15 Hungarian scientists who are carrying out 11 tobacco-related research projects throughout the country. The projects are broad-reaching, covering different populations (e.g., adolescents, adults, young mothers, the Roma population) and a variety of research questions (e.g., psychological and sociological correlates of addiction, analysis of local laws to curb tobacco use, the effect of taxation on smuggling). The projects are generally in the stages of data collection and analysis. The U.S.-based team supports the research teams by making tailored recommendations on each team’s research design and instruments, by convening annual networking meetings, and by providing access to training opportunities. This capacity-building model is being evaluated by tracking each project’s outcomes (both scientific and translational) as well as changes in individual knowledge and skills, networks, and research funding. Ultimately, this project will lead to the advancement of scientific study of tobacco use and to the dissemination of research findings that will result in innovative tobacco control interventions in Hungary. Scientists from Semmelweis University (Budapest), Davidson College, and WFSM are collaborating on this project. The Fogarty International Center (primary), the National Cancer Institute, and the National Institute of Drug Abuse funded this project.
- “Development of a Web-based Tobacco Cessation Curriculum” (R25 CA096562, PI: John Spangler). This cancer education training grant developed, implemented, and evaluated a comprehensive web-based and culturally relevant tobacco cessation curriculum for medical students. The modular tobacco cessation training materials highlight the differences and similarities in epidemiology, health risks, and cessation strategies for smoked versus smokeless tobacco, and incorporate culturally-relevant training on tobacco use and cessation counseling. These modules are highly portable as they will be in web and CD-ROM formats. This training program is in the process of being disseminated nationally. Through this project, the researchers have found that their Web-based, tobacco intervention curriculum for medical students increases knowledge, attitudes and behaviors regarding specific aspects of tobacco use and intervention. Implementation of this curriculum is described in an article.
- “Structural Integrated Pest Management in North Carolina's Spanish-Speaking Households: Using a Lay Health Advisor Approach to Community Education” (PI: Thomas Arcury) is designed to reduce unnecessary residential pesticide use in North Carolina Spanish-speaking households through the adoption of structural integrated pest management (IPM). This project will initiate a public education demonstration program with four objectives: (1) develop a lay health advisor or promotora program to teach residents of Spanish-speaking households in North Carolina about IPM and residential pesticide safety; (2) pilot-test this promotora program; (3) evaluate this promotora program; and (4) disseminate the promotora program for use by organizations and agencies.This project involves three collaborating organizations, North Carolina Farmworker Health Program (NCFHP), WFSM, and Hogar Latino (HOLA). Each organization has substantial experience in providing services to and conducting research with Latino families.
- “A CBPR Approach to Biomedical & Behavioral Health Communication with Farmworkers” (1R03 ES017364, PI: Arcury) seeks to involve farmworkers in the conduct of research that addresses their health hazards and illnesses, and to communicate research results to farmworkers in forms that they can understand and use. Through this project a partnership has been formed between an existing framework of the community-based organizations and agencies that comprise the Farmworker Advocacy Network (FAN) and health scientists at WFSM based on two principles: 1) farmworkers and their community-based organizations should collaborate with health scientists in selecting and conducting research that addresses farmworker health. 2) farmworkers should understand the results of biomedical and behavioral science so that they can better use this knowledge to improve their health and quality of life. The results of this research will provide a framework for the Farmworker Advocacy Network / WFSM partnership to collaborate effectively in the conduct of research addressing farmworker health and to communicate the results of this research to farmworkers in ways they can use.
- “African American Men Prostate and Colorectal Cancer Beliefs” (PI: Thomas Arcury) Partnering with Clinical Program colleagues (Drs. Peter Clark and John Stewart IV), this study examines the beliefs and knowledge of African-Americans needed to improve prostate and colorectal cancer screening rates and early cancer detection. Results showed that regardless of race, men viewed digital rectal exams more negatively than colonoscopies because penetration with a finger was associated with a gay sexual act This study also reported that education and not race was related to knowledge about prostate cancer and screening Results from this project have led to a proposed intervention study by providing insight into the most appropriate target for intervention, the modality of intervention, and for assuring the intervention uses culturally informed and appropriate materials.
- “Cancer Prevention for Latinas: C-CAPRELA.” (PI: Scott Rhodes) This is a follow-up to a grant that found very low Pap smear screening rates (less than 60% in the past year) and poor satisfaction with screening among uninsured Latina women. The current grant is using a novel, culturally-relevant, and empowerment-driven intervention to increase satisfaction with the Pap smear experience by changing free clinic practices in its care of non-English speaking clients. This study uses a lay health advisor model to educate and empower women so that they have the skills to negotiate the Pap smear encounter and an organizational intervention to promote a Latina-friendly climate at the local free clinic. Baseline data were collected from 172 Latinas. The 2-session intervention was successfully implemented and 12-month follow-up data are currently being collected. Dr. Rhodes has submitted an R21 grant to conduct a follow-up intervention study.
- “Clinical validity and utility of genomic targeted chemoprevention of PCa“ (R01CA140262; PI: Jianfeng Xu). This recently funded NCI GO grant, proposes to evaluate and compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches in two existing large randomized clinical trials (REDUCE and PCPT), two new study populations of men at risk for PCa, and in a survey of physicians. The unique study design of REDUCE and PCPT, with end-of-study prostate biopsies, allows this study to address two critical questions: PSA detection-bias of prostate cancer risk-associated SNPs and efficacy of genomic-targeted chemoprevention of prostate cancer using 5ARIs. Specific aims are the following: 1) to assess the clinical validity of PCa risk prediction models using a panel of non PSA detection biased PCa risk-associated SNPs. 2) to identify and assess the clinical validity of novel polymorphisms that interact with 5ARIs in reducing PCa diagnosis using both genome-wide and candidate gene approaches, 3) to assess the clinical utility of a genomic-targeted approach by comparing its reduction in rates of PCa with non-targeted chemoprevention, 4) to compare perception and decision making of physicians and patients for genomic and non-genomic-targeted chemoprevention of PCa, and 5) to compare the cost-effectiveness of genomic and non-genomic-targeted chemoprevention of PCa. Results from this study will provide comprehensive data for evidence-based evaluation by the Center for Disease Control’s EGAPP working group, provide a proof of principle study of comparative effectiveness research (CER), and will help build a road map for future genomic and personalized medicine (GPM) in the 21st century.