Funded Research

The following are some examples of the funded research projects that mentors and cancer control researchers are working on and are available for research participation and manuscripts. The projects are divided into the following research areas: (1) Quality of Life; (2) Lifestyle; (3) Symptom Management; (4) Tobacco Control; (5) Clinical Care; and (6) Other Opportunities.

Quality of Life

• “Menstrual Cycle Maintenance and Quality of Life Following Treatment for Breast Cancer: A Prospective Study” (DOD; PI: Michelle Naughton). This study began in 1996 to study menstrual cycle patterns following treatment for breast cancer.  It is perhaps the largest prospective study (N=836) in the world to determine the impact of breast cancer treatment on menstrual bleeding/amenorrhea and subsequent fertility. The goals of this multi-center study are to: (1) 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) track any subsequent pregnancies and their outcomes, and (3) study the impact of a breast cancer diagnosis and treatment on QOL. This dataset provides a wealth of data on premenopausal women who develop breast cancer.
• “Investigating Mechanisms to Explain Age Associated Differences in Quality of Life among Breast Cancer Patients” (DOD; PI: Nancy Avis).  The primary purpose of this study is 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.  Extensive treatment, quality of life, and psychosocial data are available for secondary analyses.
• “Prevalence and Health Status of Cancer Survivors in the Rural US” (1R03CA156641-01 PI: Kathryn Weaver).  The purpose of this study is to provide population-based information about the characteristics and health status of adult cancer survivors who reside in rural areas of the United States using data from the National Health Interview Survey. The characteristics and health status of rural and non-rural adults with cancer will be compared and known risk factors for poor health, including physical activity, body mass index, smoking history, socioeconomic status, and access to medical care,  will be examined.  This dataset provides an excellent opportunity to conduct analyses using a large national database.
• “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 parathyroid hormone (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 are treating 30 men for 16 weeks to suppress serum PTH levels to =50% of its baseline values to 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. This project also tests 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.

Lifestyle 

• “Research on Optimal Recovery Practices in Breast Cancer (RESTORE)” (DOD: PI: Shannon Mihalko).  This study was a randomized trial of an exercise intervention to improve the QOL and reduce lymphedema among breast cancer survivors.  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.
• “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 objective of this study is to test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy. A secondary objective is 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.

 Symptom Management 

• “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. This project evaluates the effectiveness of yoga as an intervention for treating hot flashes.  Hot flashes are particularly problematic for breast cancer survivors since the most effective treatment, hormone therapy, is contraindicated for survivors of hormone-dependent cancers.  This study randomly assigned 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.
• “Non-Specific Effects of Acupuncture in the Treatment of Hot Flashes” (1R01AT005854 PI: Nancy Avis)  The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the “real world” setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.

Tobacco Control

• “Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study” (NCI CCOP Clinical Trial PI: Kathryn Weaver).   The goal of this pilot study is to demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients (n=30) in the outpatient oncology setting. We will also examine preliminary biologically confirmed smoking abstinence rates and patient-reported outcomes (quality of life, symptoms, perceived stress, and depression) in patients assigned to the intervention vs. usual care condition.
• “Tobacco Use Trajectories and Surgical Outcomes in Newly Diagnosed Head and Neck Cancer Patients in North and South Carolina” (CCCWFU/ MUSC Joint Pilot Grant Co-PIs: Weaver, Sullivan, Sterba, & Day).  This pilot study will 1) provide preliminary data to understand the trajectory of tobacco use in head and neck cancer patients and the influence of tobacco use on surgical outcomes and 2) build collaborations for future interdisciplinary research among clinicians and researchers at the Comprehensive Cancer Center of Wake Forest University and the Hollings Cancer Center at the Medical University of South Carolina.
• “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 project developed and implemented a web-based survey of college administrators from 152 colleges and universities in the Southeastern United States and conducted in-person interviews that provided 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. 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: 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. The specific aims are: (1) to measure trajectories of SLT use among undergraduate college students over the course of their college careers; (2) to identify environmental and individual-level correlates of trajectories of SLT use; and (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: Kristie Foley, Davidson College; Consortium 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. The study aims to (1) increase free clinics’ organizational readiness to adopt the United States Public Health Service’s Guidelines on Treating Tobacco Use and Dependence; (2) evaluate the efficacy of the evidence-based strategies in promoting tobacco cessation behaviors among the clinics’ health care volunteers and uninsured patients; and (3)test 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.
• “Implementing Evidence-Based Tobacco Cessation Strategies in Campus Health Clinics” (R21CA161664, PI: Erin Sutfin). This study seeks to provide formative data testing the implementation of evidence-based tobacco cessation strategies in student health clinics on college campuses in North Carolina. Specific aims are to: (1) Increase student health centers’ organizational adoption and implementation of the PHS Guidelines through system-level changes; and (2) Increase college student health care providers’ adoption and implementation of the PHS Guidelines to promote tobacco cessation behaviors among college student tobacco users. A Secondary Aim is to preliminarily assess the efficacy of implementing the PHS Guidelines in student health centers on students’ quit attempts. Using a clinic-level randomized design, the intervention targets both organizations providing healthcare and clinicians within those organizations through system-level changes and increased provider training. This study responds to an unmet need for the successful implementation of evidence-based tobacco cessation strategies for college students. The overall intent of this research is to ultimately close the gap between research discovery and program delivery in the area of tobacco control.

Clinical Care 

•   “Clinical validity and utility of genomic targeted chemoprevention of PCa” (R01CA140262; PI: Jianfeng Xu) This NCI Grand Opportunity (GO) grant is evaluating and comparing 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. 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.  
• “Long-term Survivorship in Older Women with Early Stage Breast Cancer (5R01CA093772; PI: Rebecca Silliman, Boston University; PI on subcontract: Ann Geiger) This is a follow-up grant to continue following a cohort of 1859 women 65+ years of age with early state breast cancer and to enroll a comparison cohort of women without breast cancer. 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.
• “Cancer-related Follow-up Care Experiences of Rural Cancer Survivors”  (1R03CA157211-01A1 PI: Kathryn Weaver)  The goal of this pilot grant is to gather preliminary data on the cancer-related follow-up care experiences, perceived barriers to care, and information needs of cancer survivors residing in rural areas. We will survey approximately 230 two to five year breast, prostate, and colorectal cancer survivors recruited from an academic medical center that serves a large rural population.
• “Modification of tamoxifen effectiveness by gene-drug and drug-drug interactions” (NCI, Danish Cancer Society, and Danish Medical Research Foundation; PI: Tim Lash).  Tamoxifen is an anti-estrogenic treatment that reduces the risk of breast cancer recurrence by almost half in women whose tumors express the estrogen receptor. Using the clinical registry maintained by the Danish Breast Cancer Cooperative Group, this study identified approximately 900 cases of breast cancer recurrence and their 900 matched controls free of recurrence. The registry provided data on tumor and treatment characteristics, and the study team collected paraffin-embedded tumor tissues archived following breast cancer surgery. From these tissues, the team collected genomic DNA, mRNA, and microRNA and then created tissue microarrays to facilitate assays of protein expression. The study has used these biospecimens to investigate a wide range of molecular biomarkers of Tamoxifen resistance.

Other Opportunities for Trainees 

• “CCOP Research Base” (U10 CA081851; PI: Dr. Shaw)  The CCCWFU Community Clinical Oncology Program (CCOP) Research Base provides a unique opportunity for trainees to conduct research outside of an academic cancer center.  The CCOP Research Base is a mechanism for conducting Cancer Center investigator-initiated trials within a large number of community cancer centers(about 160), thus providing opportunities for moving research from our academic cancer center to the community and for recruiting large numbers of patients.  Our Research Base is one of only four such Cancer Center Research Bases in the United States.

Research Base funding provides the infrastructure to conduct investigator initiated trials within the CCOP system. The focus of the Wake Forest Research Base has been on symptom management interventions and more recently has expanded its focus to include observational research and behavioral interventions.  Several of our program mentors are actively involved in Research Base studies.

• “Women’s Health Initiative Southeast Regional Center” (NHLBI-WH-11-10 “Women’s Health Initiative Extension 2010-2015:  The Southeast Regional Center; PI: Shumaker)  The highly regarded Women’s Health Initiative has been organized around four regional centers (RCs) and the Central Coordinating Center (CCC).  We at Wake Forest serve as the Southeast Regional Center.  This contract provides excellent opportunities for members of our Program to propose and participate in these ancillary studies.  With the Regional Center based at WFUHS, we have immediate access to the study infrastructure, training opportunities, and the knowledge base of the local investigators.  To date, the WHI consists of detailed information on approximately 160,000 postmenopausal women, making it one of the largest and richest datasets to examine both risks for cancer and cancer survivorship.

The WHI is anticipating that over 100,000 women will continue to actively participate in this landmark study for the next extension period. This is an especially valuable dataset for studying less prevalent cancers such as ovarian, endometrial, and pancreatic cancer where numbers are often too small at single or even multiple sites.  The WHI Southeast-RC contract allows opportunities for investigators to submit proposals for extramural funding.  Access to this data provides excellent opportunities for our R25T postdoctoral fellows.