Post-Doctoral Training Grant In Cancer Survivorship

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) Symptom Management & Quality of Life; (2) Rural Cancer Survivors/Health Disparities (3) Lifestyle Interventions; (4) Late Effects; (5) Tobacco Control; (6) Cognition and (7) Other Opportunities.

Symptom Management & Quality of Life 

  • Acupuncture for the Treatment of Hot Flashes.(1 R01 AT005854; PI:Avis, PhD, Kathryn Weaver, PhD, Suzanne Danhauer, PhD, Julia Lawrence, MD)We have studied two alternative treatments for hot flashes in women: acupuncture and yoga. A recently completed trial, “Acupuncture Treatment for Menopausal Hot Flashes” (R21 CA104427; PI: Avis) randomized women to one of three groups: true acupuncture, sham acupuncture, or usual care.  We found a significant decrease in mean frequency of hot flashes, but no difference between the two acupuncture groups, but both showing a significantly greater decrease in hot flashes compared to the usual care group (Avis et al. Menopause, 2008).  These results suggest either a strong placebo effect or that both traditional and sham acupuncture significantly reduce hot flash frequency.  A subsequent is currently underway to provide greater insight into the effectiveness of acupuncture for hot flashes (R01 AT005854-01 “Acupuncture for Hot Flashes” PI: Avis). This study is randomizing 200 women to examine real world effectiveness of acupuncture for hot flashes among cancer survivors and menopausal women.

  • Symptom Management for Leukemia Inpatients: Exercise and Yoga (SMILE). (PI:Suzanne Danhauer, PhD, Shannon Mihalko, PhD, Barbara Nicklas, PhD, Janet Tooze, PhD, Stephanie Sohl, PhD). This R01 grant will be resubmitted in July 2013. Acute leukemia (AL) patients are an important group given substantial emotional and physical symptom burden in the midst of intensive induction chemotherapy regimens requiring lengthy inpatient stays. This study is a randomized, controlled trial that will compare the efficacy of two 4-week cancer-adapted individualized interventions [gentle yoga or physical activity (PA)] versus usual care in newly diagnosed adults with AL on the following outcomes: depressive symptoms, fatigue, sleep quality, physical function, and range of motion. The study will also examine several potential biological (inflammatory cytokines) and psychosocial (perceived stress, spirituality) mechanisms of action for the interventions. We will recruit a sample of 246 adult (≥21 years) patients with acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) undergoing induction chemotherapy who report clinically meaningful levels of depressive symptoms or emotional distress and randomly assign them to one of three groups: gentle yoga, physical activity or usual care. If validated, this study will yield 2 well-developed interventions for use with AL inpatients and elucidate potential mechanisms of action for future studies. These interventions could improve cancer-related symptoms for the nearly 20,000 AL patients who are treated each year, and may be extended to inpatients with other cancers and other diseases.

  • Reducing Lung Cancer Survivor Anxiety (RELAX) with Brief Device-Guided Breathing. (PI: Danhauer, PhD; Kathryn Weaver, PhD) This R21 grant was submitted in February 2013. Lung cancer is the second-most common cancer diagnosed in the US, yet little “survivorship” research has focused on this population. As the number of early stage lung cancer (ESLC) survivors increases because of uptake in low dose computerized tomography lung cancer screening, it will be increasingly important to develop interventions to improve their well-being. The goal of study is to determine feasibility of a device-guided breathing intervention versus a music control group and to obtain preliminary data on effects on anxiety, dyspnea, pulmonary function, and functional fitness in ESLC survivors. This study will enroll 60 post-treatment ESLC survivors with clinically meaningful anxiety symptoms through two sites of the Wake Forest Community Clinical Oncology Program Research Base (WF CCOP RB). Participants will be randomly assigned to one of three groups: low-dose (15 minutes, once per day) RESPeRATE device-guided breathing (n=20), high-dose (15 minutes, twice per day) RESPeRATE (n=20), and music control (15 minutes, once per day) (n=20). The results of this study will provide outstanding preliminary data for our planned R01 application for a larger randomized controlled trial that will be run through the WF CCOP RB that can better elucidate the impact of the proposed simple intervention for anxious, post-treatment ESLC survivors, that can be easily disseminated. 

  • Work Ability in Young Adult Survivors (WAYS): A Mixed-Methods Study. (PI: Danhauer; Sharon Castellino, MD, Janet Tooze, PhD). This R01 grant was submitted in February 2013. Despite the growing number of young adult cancer survivors, a group early in their career trajectory, little is known about how cancer-related impairments in physical, cognitive and psychosocial functioning limit work ability and labor force participation among young adult survivors of adolescent and young adult onset cancers. The goals of this study are to: (1) document levels of work ability, labor force participation, occupational status, and educational attainment following cancer treatment in young adult survivors; (2) determine associations of self-reported physical, cognitive, and psychosocial issues related to cancer and its treatments with work ability in young adult survivors; and (3) delineate common themes in: (a) experiences of young adult survivors in how physical, cognitive, and psychosocial issues following cancer diagnosis/treatment have affected their work ability, labor force participation, occupational status, and educational attainment; (b) how these experiences change over two years; and (c) adjustments that survivors make in response to effects of cancer diagnosis/treatment on their occupational and educational attainment. This study will take advantage of the Wake Forest Community Clinical Oncology Program Research Base to recruit a representative, ethnically diverse sample of young adult cancer survivors (N=300) aged 25-34 years who will complete cognitive testing and a detailed questionnaire. A subset of 90 participants will complete an additional semi-structured, in-depth interview regarding perceptions of their cancer/treatment, physical, cognitive, and psychosocial difficulties related to cancer/treatment, and employment/educational experiences and a 2-year follow-up of the questionnaire, cognitive testing, and in-depth interview. This study will provide detailed information essential for designing policy and supportive interventions to aid young adult cancer survivors in achieving occupational and educational success.

  • Investigating Mechanisms to Explain Age Associated Differences in Quality of Life among Breast Cancer Patients. (PI:Nancy Avis, PhD, Co-I: Michelle Naughton, PhD). The purpose of this study is to better understand why younger women have greater psychological morbidity following a breast cancer diagnosis than older women and to examine age-related differences in treatment.  This prospective observational cohort study has enrolled over 650 women and followed them for 2 years post diagnosis. Although funding has ended for this project, it provides a rich resource for manuscripts related to cancer survivorship for the WFSM CECDT postdoctoral fellows with 7 manuscripts published, in press, or well underway.  

    Rural Cancer Survivors/Health Disparities 

    • Prevalence and Health Status of Cancer Survivors in the Rural US (5R03CA156641-02; PI: Kathryn Weaver, PhD, Co-Is: Ann Geiger,PhD, L. Doug Case, PhD) is a study using data from the National Health Interview Survey to generate the first population-based estimate of the number of US cancer survivors who reside in rural areas and to describe their socio-demographic and cancer characteristics, health behaviors, health care utilization, and health status (self-reported health, psychological distress, non-cancer comorbidities, and unemployment due to health). 

    • Cancer-related Follow-up Care Experiences of Rural Cancer Survivors.  (5R03CA157211-02; PI: Kathryn Weaver, PhD; Co-Is: Nancy Avis, PhD, Janet Tooze, PhD) This study surveyed breast, prostate, and colorectal cancer survivors (n=174) who were two to five years post-diagnosis and resided in rural areas. Key topics of interest included characteristics of post-treatment follow-up care received, barriers to follow-up care, health-related information needs, and adherence to screening and surveillance guidelines.

    • Survivorship Care Planning and Communication for Rural Breast Cancer Survivors (5R21CA155932-02; PI: Ann Geiger, PhD, Co-Is: Kathryn Weaver, PhD, Julia Lawrence, DO, L. Douglas Case, PhD). The purpose of this study is to gather information about rural-, suburban- and urban-residing breast cancer survivors' (n=207) needs and preferences for their survivorship care, in order to support design and evaluation of a survivorship care planning and communication intervention with particular accommodation for the needs and preferences of rural-residing survivors.  As a study co-investigator, I played a key role in the development of the survey and the recruitment protocols. I will continue to collaborate on data interpretation and manuscript development and will lead a manuscript describing follow-up care experiences and preferences.

    • End of Treatment Transition to Follow-Up Care among Early Stage Lung Cancer Survivors

      (NCI, PI: Weaver, PhD, Co-Is: Janet Tooze, PhD, James Urbanic, MD, William J. Petty, MD, Jimmy Ruiz, MD)  (Pending R01) The proposed mixed-methods study will focus on an understudied, but growing population, early stage lung cancer survivors, and gather novel data on their follow-up care transition experiences and needs. This study will recruit patients diagnosed with localized lung cancer who have completed primary treatment within the past 3-24 months to explore lung cancer survivors’ experiences in the two years after initial treatment, focusing on their health needs, communication with treatment team, and psychosocial concerns using both semi-structured interview and survey research strategies.

    • Maximizing the Impact of ePHIM in Low Income, Multiethnic Populations (PI: David Miller, MD).The ability to access, manage, and understand personal health information enables individuals to become better consumers and participate more fully in making health care decisions.  The development of electronic health records and the availability of patient portals for accessing personal health records, coupled with myriad health information via the internet (eHealth), have provided the potential for electronic personal health information management (ePHIM).  However, great variability exists in access to eHealth information for components of the US population. Despite continuing efforts, this “digital divide” remains for rural, minority and low-income communities.  Limited access for ePHIM contributes to the health disparities experienced by these populations.  The goal of this project is to improve the ability of low-income African American, American Indian, Latino, and white older adults living in rural and urban communities to use information technology applications for ePHIM.  The project’s conceptual framework combines the Technology Acceptance Model and the person-environmental interaction model.  It uses a community-based participatory partnership of Wake Forest School of Medicine and its Outpatient Department Medicine Clinic, with Community Partners HealthNet, a network of 18 clinics serving 25 rural North Carolina counties, to achieve 3 specific aims:  (1) document the ePHIM experience, knowledge, perceived needs, and perceived risks of low-income African American, American Indian, Latino, and white older adults living in rural and urban communities; (2) delineate the actual use of ePHIM by low-income African American, American Indian, Latino, and white older adults living in rural and urban communities; and (3) delineate differences in perception, belief and experience in using ePHIM between patients and caregivers who use versus those who do not use ePHIM.  This project is significant because it will delineate disparities in ePHIM by working with two networks of clinics (Community Partners HealthNet; Outpatient Department Medicine Clinic/Wake Forest Baptist Health) that provides care to rural and urban, low-income, and minority patients.  Working with these networks, this project will implement in-depth and longitudinal research that will delineate the factors affecting ePHIM use among vulnerable elders.  This project is innovative.  (1)  It will use qualitative data collection techniques within a community-based participatory research framework to assess the motives and barriers to patients’ and caregivers’ ePHIM among rural as well as urban, low-income, older adult, and minority communities.  (2) It emphasizes the importance of including caregivers, particularly for older adults, in understanding the use of ePHIM.   (3) It will use these qualitative methods to assess the perceptions of health care providers and IT providers about the potential use of ePHIM.  (4) It will use these qualitative methods to determine the factors that facilitated and limited the use of ePHIM by comparing high / expert, medium, and low users.  (5) It will document the actual pattern of ePHIM use among older adults and their caregivers over a one-year period.  (6) It will explore the association of ePHIM use and chronic disease management among older adults.

    Lifestyle Interventions

    • Prosocial Behavior and Volunteerism to Promote Physical Activity in Older Adults (5R01 HL109429; PI:Capri Foy, PhD,Mara Vitolins, PhD, Janet Tooze, PhD) is a 5-year randomized controlled trial that compares the effect of a “healthy aging” control intervention (n=150) vs. that of a physical activity intervention (N=150) which embeds prosocial behavior and volunteerism upon physical activity at 12 months. Three hundred men and women aged 55 to 80 years are being randomized into the two interventions. This study involves administration of questionnaires, direct measures of blood pressure, body weight and size, and direct measures of physical performance. In addition, survivors of cancer are eligible for this study, which may provide opportunities for qualitative interviews and assessments which address cancer survivorship.

    • Prosocial Behavior to Promote Physical Activity among Colorectal Cancer Survivors (PI: Capri Foy, Suzanne Danhauer, Mara Vitolins), is a pending study designed to determine whether a 9-month, cognitive-behavioral physical activity intervention using prosocial behavior (n=30) is feasible and acceptable to colorectal cancer survivors, compared to a physical exercise attention control intervention (n = 30). Participants will be ambulatory, physically underactive, community-dwelling adults aged > 21 years who are 3 to 60 months post-treatment for CRC. The primary aims of the study are (1) to develop and refine the protocols for the two interventions; (2) to determine the feasibility and participants’ acceptability, in terms of successful recruitment, adherence and retention of conducting a fully powered trial; and (3) to obtain preliminary data to determine effect sizes and sample calculations for physical activity (assessed via self-report and accelerometry), physical function, and quality of life.

    • Taking Health Realization into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors during Chemotherapy. (PI:Shannon Mihalko, PhD, Suzanne Danhauer, PhD). The goal of the THRIVE pilot study is to demonstrate the feasibility of conducting a randomized clinical trial to test the effectiveness of an intervention to prevent weight gain for breast cancer survivors during chemotherapy. This study tests the efficacy of the intervention as a springboard to a short-term healthy lifestyle program.

    • Loss of fat tissue and functional responses to exercise in older, obese adults (R01 AG020583; PI:  Barbara Nicklas, PhD) The primary goal of this randomized, clinical trial is to determine whether addition of caloric restriction to a standardized, progressive resistance training (RT) program enhances improvements in skeletal muscle and overall physical function in 120 older (65-79 yrs), overweight/obese adults.  We will also examine the effects of the two interventions on in vitro characteristics of skeletal muscle and on systemic inflammation. 

    • Effect of fat loss on functional and cardiovascular benefits of aerobic exercise (R01 HL093713; PI:  Barbara Nicklas, PhD). This randomized, clinical trial will determine whether older, obese men and women who lose more fat during an exercise training program will experience greater improvements in aerobic function as a result of the exercise training.  The study is designed to assess the effects of adding moderate (-250 kcal/d deficit) or intensive (-600 kcal/d deficit) caloric restriction to a standardized aerobic exercise training intervention on maximal aerobic capacity (VO2max), functional endurance (400-m walk time), CVD risk factors (inflammatory markers, blood lipids, blood pressure, glucose tolerance and endothelial function), and inter-muscular, abdominal visceral and pericardial fat volumes.

    • Effects of Dietary Omega-3 Fatty Acids on AKT signaling in prostate cancer (5R01CA107668-09; PI:Yong Chen, PhD). The goal of this research is to determine the effects of n-3 fatty acids on the phosphoinositide signaling pathway and Akt Signaling. There are two major dietary sources of ?3 polyunsaturated fatty acid (PUFA): the botanic ?3 PUFA [1-linolenic acid (1LNA, 18:3n-3)] and the marine I3 PUFA [eicosapentaenoic acid (EPA, 20:5n-3) and docosahexaenoic acid (DHA, 22:6n-3)]. We have previously demonstrated that prostate cancer risk can be favorably modified by marine I3 PUFA in a genetically predisposed mouse population and that modulation of prostate cancer development by PUFA is mediated in part through Bad-dependent apoptosis. Our recent evidence shows that active Akt protein localizes on the plasma membrane in prostate tumor tissues from mice on I6 diet, whereas it is primarily localized in the cytoplasm in tumor tissues from mice on ?3 diet enriched with DHA. It is unclear how ?3 fatty acids alter Akt localization, and how this in turn affects the function of Akt substrates such as the proapoptotic Bad protein. In mammals, the first carbon (sn-1 position) of the glycerol backbone in phosphatidylinositols (PIP) is usually linked to a saturated fatty acid, the second carbon (sn-2 position) to an ? 6 PUFA, and the last carbon to inositol. We found that DHA can replace the ?6 fatty acid at the sn-2 position of PIPs in cell culture, thereby generating different species of PIPs. We hypothesize that ?6- and ? 3-containing PIPs will localize to different cellular membranes due to their differences in number and/or position of double bonds, resulting in Akt recruitment and activation at different cellular locations, and consequently differential Bad phosphorylation, apoptosis and tumor suppression. To test our hypothesis, we propose to (1) Determine if different I3 fatty acids are similarly incorporated on the sn-2 position of PIPs and if this incorporation affects their subcellular localization in vitro, (2) Determine if ?3 fatty acid incorporation affects the localization and activity of Akt and Bad in vitro, and (3) Confirm the ability of different I3 fatty acids to alter PIP and Akt localization as well as Bad phosphorylation and to suppress prostate cancer in vivo.

    • Omega-3 PUFA-Gene Interaction in Prostate Cancer (5R01CA163273-02; PI-Yong Chen). The goal of this research is to study the interaction between dietary PUFA and their metabolic enzymes in prostate cancer.  We have previously shown that I3 PUFA reduced prostate cancer (PCa) growth, slowed histopathological progression and increased survival, whereas I6 PUFA had the opposite effects. We hypothesize that I3 PUFA is primarily metabolized by Cox1 in vivo and that the anti-proliferative effect of I3 PUFA is, in part, mediated by Cox1 metabolite(s). Furthermore, I6 PUFA is metabolized by Cox1, Cox2 and Lox5, and the corresponding metabolites play important roles in stimulating PCa growth. To test our hypothesis, three specific aims are proposed: (1) Study the cellular mechanism(s) of PUFA-gene interaction on PCa growth, (2) Identify metabolite(s) of I3 and I6 PUFA important in PCa and (3) Examine metabolite signaling in PCa cell proliferation and apoptosis.

     Tobacco Control 

    • Smokeless Tobacco Use in College Students (5R01CA141643-04; Co-PIs: Mark Wolfson, PhD; John Spangler, MD;  Co-Is: Beth Reboussin, PhD, Erin Sutfin, PhD). The goal of this study is to better understand trajectories and correlates of SLT use among college students. To do this we will measure trajectories of SLT use among undergraduate college students over the course of their college careers; identify environmental and individual-level correlates of trajectories of SLT use; and 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).

    • Dissolvable Tobacco Perceptions and Use among Young Adults in Test Markets (3R01CA141643-04S2, Co-PIs: Mark Wolfson, PhD, John Spangler, MD,  Co-Is: Beth Reboussin, PhD, Erin Sutfin, PhD, Kim Wagoner, EdD) A new generation of dissolvable tobacco products has been introduced into test markets in the U.S.  This study assesses perceptions and use of these products in three test markets where they are currently available (Denver, CO, Charlotte, NC and various cities in Kansas).  This information will better enable the Food and Drug Administration to fulfill its responsibilities regarding regulation of these products under the Family Smoking Prevention and Tobacco Control Act of 2009.

    • Tobacco Use Trajectories and Surgical Outcomes in Newly Diagnosed Head and Neck Cancer Patients in North and South Carolina (Comprehensive Cancer Center of Wake Forest University / Hollins Cancer Center, Medical University of South Carolina Joint Pilot Grant; Co-PIs: Kathryn Weaver, PhD, Katherine Sterba,PhD,  Christopher Sullivan, MD, Terry Day,MD;  Co-Is: Janet Tooze) The goal of this observational pilot study was to understand the influence of smoking status on surgical outcomes in head and neck cancer patients (n=109) and to gather preliminary data that can be used to translate study findings into future clinic-based interventions for head and neck cancer patients.

    • End of Treatment Transition to Follow-Up Care among Early Stage Lung Cancer Survivors (NCI, PI: Weaver, Co-Is: Janet Tooze, James Urbanic, William J. Petty, Jimmy Ruiz; pending)  The proposed mixed-methods study will focus on an understudied, but growing population, early stage lung cancer survivors, and gather novel data on their follow-up care transition experiences and needs. This study will recruit patients diagnosed with localized lung cancer who have completed primary treatment within the past 3-24 months to explore lung cancer survivors’ experiences in the two years after initial treatment, focusing on their health needs, communication with treatment team, and psychosocial concerns using both semi-structured interview and survey research strategies.

    • Effective Communication on Tobacco Product Risk and FDA Authority (NIDA, PI: Kurt Ribisl, PD: Erin Sutfin, Co-Is: Reboussin, Mark Wolfson, Wagoner) (pending) The goal of the proposed center grant is to advance regulatory science by using communication science to improve messages about cigarette smoke constituents, emerging tobacco products, and FDA’s regulatory authority over tobacco. The proposed center aims to conduct three integrated research projects among vulnerable populations and across the lifespan to inform regulatory science. 

    • Trajectories and Perceptions of Hookah Tobacco Use Among Youth and Young Adults (NCI/FDA, PI: Garvin, PD: Erin Sutfin, Co-Is: Reboussin, Mark Wolfson, John Spangler) (pending) Hookah tobacco smoking is growing in popularity around the world, including in the U.S., especially among adolescents and young adults. The proposed study will (1) examine associations between product characteristics, including flavoring, labeling, and marketing and adolescents’ and young adults’ risk perceptions and product use; and (2) assess trajectories of hookah tobacco smoking among a large cohort of young adults to measure the potential public health risks associated with hookah use. This research would inform regulatory strategies that the FDA can use to establish rules about hookah tobacco to protect the public health.

    Cognition

    • Women’s Health Initiative Memory Study (PI: Sally Shumaker, Co-Is: Michelle Naughton, Steve Rapp). A long standing ancillary to WHI is the Women’s Health Initiative Memory (WHIMS) suite of studies.  These studies were developed by Dr. Shumaker and colleagues and the WHIMS coordinating center is also located at WFSM.  Beginning in 1996, the WHI included a unique and detailed assessment of global cognitive functioning, mild cognitive impairment,  and dementia  on a subset of women (aged 65 and older) who were enrolled in the WHI hormone trials  (N=7,450).  Follow-up of about 3,700 of these women still continues.  The Women’s Health Initiative Study of Cognitive Aging (WHISCA) and the Women’s Health Initiative Magnetic Resonance Imaging (WHIMS-MRI) study were conducted on subsets of WHIMS participants.  In addition, the Women’s Health Initiative Memory Study of Younger Women (WHIMS-Y) began in 2008.  This study is designed to assess the long-term impact of random assignment to postmenopausal hormone therapy among women who were 50-54 years of age at the time they were initially enrolled into the WHI hormone trials.  Hormone therapy continues to be widely prescribed for the treatment of menopausal symptoms.  There remains a strong belief among basic and clinical scientists that hormone therapy begun during the peri- or immediate post-menopausal periods may bestow cognitive benefits and that the cognitive harm associated with hormone therapy in the post-menopausal woman occurs only when there is some pre-existing, sub-clinical disease and/or the aging brain is more vulnerable to the possible negative effects of hormones.  This specific issue was not addressed within the original WHIMS cohort, and WHIMS-Y takes advantage of the rich WHI cohort by adding critical information on the clinical treatment of peri-menopausal and early post-menopausal women and on potential mechanisms of action for how HT may affect cognition. 

    • Both WHI and WHIMS provide a wealth of opportunities to study factors related to cancer prevention and control, as well as survivorship, due to rich data on dietary habits, exercise, social support, comorbidities, quality of life and health disparities.  Both Drs. Shumaker and Naughton have been involved in WHI since its inception, and will assist the post-docs in working with WHI and WHIMS data.

    • Phase III Study of Donepezil in the Irradiated Brain (R01 NR009675-01A2; PI: Steve Rapp; Co-I: Michelle Naughton)  This recently completed Phase III randomized, placebo-controlled, double blind clinical trial tested the efficacy of donepezil (5mg x 6 wks, 10 mg x 18 weeks) to improve cognitive functioning in brain tumor survivors > 6 months following brain radiation treatment.  Data analyses are currently underway and post-docs will be encouraged to use them for papers and ancillary study proposals. 

    • PPARs and Radiation-Induced Brain Injury (5R01CA112593-10; Co-PIs Linda Metheny-Barlow and William Blackstock).  This study examines the mechanisms by which radiation of the brain leads to brain injury, including cognitive impairment, and evaluates the ability of PPAR agonists to ameliorate the damage and protect cognition in rodent models. Dr. Metheny-Barlow is also working on the development and characterization of models to study breast cancer brain metastasis development and treatment.  As part of a recently completed DoD pilot grant, she has developed a unique brain metastasis-bearing rat model to study effects of therapeutic fractionated whole brain irradiation on tumor response and cognition; this model better represents the human condition where damage results from a combination of tumor and therapy.

    Other Opportunities for Trainees 

    • Gene-Hormone Interaction and Risk of Breast Cancer(5R01CA149135-03; Co-PI: Mara Vitolins;). The overall hypothesis of this study is that common genetic variants can be used to classify women into low or neutral risk groups for developing breast cancer due to HT use (gene-hormone interaction). We specially hypothesize that 1) a subset of genetic variants account for individual differences in risk of developing breast cancer upon HT use (E+P or E only) on breast cancer risk, 2) those SNPs may or may not alter the risk of developing CVD upon HT use. We will identify the genetic variants using data and samples from the Hormone Therapy Trial (HT) of the Women's Health Initiative (WHI) study, a large randomized, double-blind, placebo-controlled clinical trial, and perform a replication study in the WHI Observational Study (OS). To test these hypotheses, we have four specific aims. Aim 1 is to identify SNPs that account for individual differences in risk of developing breast cancer upon HT use (SNP-HT interactions). Aim 2 is to confirm the top significant SNPs identified in Aim 1 among women in the OS arm. Aim 3 is to evaluate the SNP-HT interaction with other phenotypes (primarily CVD) among women in the OS arm. Aim 4 is to estimate the individual absolute risk of developing breast cancer upon HT use among women in the OS arm. The identified genetic variants will be used to create a risk-benefit profile for HT treatment and may potentially improve clinical decision making for HT use. 

    • The Study of Women’s Health Across the Nation (SWAN) (3U01 AG12546; , Wake Forest PI: Nancy Avis) is a large multi-site, multi-ethnic 15-year study of mid-aged women as they transition through menopause.  The dataset includes psychosocial factors, health risks and health behaviors, physiological measures, and disease outcomes.  The data provide the opportunity to prospectively examine cancer survivorship among those women who develop cancer over the course of the study and to compare health status to healthy controls. An ancillary study focused on cancer survivors is planned for the Fall.

    • A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients with Acute Leukemia (Intramural grant; PI: Shannon Mihalko; Co-Is:  Suzanne Danhauer, Heidi Klepin).   Acute myelogenous leukemia (AML) is a disease of older adults characterized by disproportionately worse survival associated with increasing age. Adults undergoing intensive treatment for AML frequently experience substantial physical deconditioning, treatment-related symptoms and emotional distress.  Development of evidence based treatment guidelines for older adults will depend upon targeted interventions designed to minimize the impact of therapy in this population on physical function and quality of life.  The goal of this pilot study is to demonstrate the feasibility of conducting a randomized clinical trial to test the effectiveness of a physical activity intervention for older adult patients with acute leukemia who are undergoing induction or reinduction chemotherapy on physical and psychological health.

    • Paricalcitol for Palliation in Advanced Prostate Cancer: A Phase II Trial; PI: Schwartz) This ongoing Phase II clinical trial is being conducted in men with androgen-insensitive prostate cancer who have bony metastases and who have significantly elevated serum parathyroid hormone (PTH). 19-nor-1,25-Dihydroxyvitamin D2 (Zemplar, a paricalcitol capsule), is an FDA-approved oral vitamin D analogue, being used to suppress serum PTH.  We have previously shown that this drug in intravenous form inhibits the proliferation of prostate cancer cells in vitro.  , this research represents a translation of our laboratory and clinical trial work to an investigator-initiated extramurally-funded, clinical trial. The current trial is in the process of enrolling 30 men with advanced prostate cancer for 16 weeks to suppress serum PTH levels to ≥50% of their 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 QOL;  2) test the hypothesis that subjective changes in bone pain and improved QOL will be associated with objective changes in bony remodeling, as assessed by biochemical markers of bone resorption and bone formation; and 3) use these data to plan a blinded, placebo-controlled Phase III trial of paricalcitol in pain reduction and QOL in metastatic prostate cancer. 

    • Access to large studies and datasets.  In addition to funded research projects, mentors can provide access to a number of datasets that provide opportunities for immediate analyses and manuscripts.  Public Health Sciences faculty serve as PIs on numerous cohort studies and clinical trials either as a coordinating center or clinical site for some of the largest NIH-sponsored studies and trials, e.g., Women’s Health Initiative (WHI), Multi-ethnic Study of Atherosclerosis (MESA), The Insulin Resistance and Atherosclerosis Study (IRAS), Action to Control Cardiovascular Risk in Diabetes (ACCORD), Cardiovascular Health Study (CHS), Atherosclerotic Risk in Communities (ARIC), and Action for Health in Diabetes (Look AHEAD).  These studies offer trainees opportunities to address important scientific questions by taking advantage of existing data or cohorts with accompanying clinical and biological data. The Cancer Control Program has compiled a database of these studies to encourage faculty to make use of existing data for ancillary studies or secondary analyses.  An excellent example of this is the recent contract awarded to Drs. Jianfeng Xu and Mara Vitolins (“Evaluation of Interaction Effects of Genes in the Inflammation Pathway with Diets, Supplements, and Medicine Exposures on General Cancer Risk”) which is based on data from the WHI.  Drs. Vitolins and Shumaker are active participants in the WHI and their familiarity with this study helped in securing this funding.  These existing studies provide excellent opportunities for trainees to obtain small R03 grants. 

    • Social Host Policy Development & Enforcement - a CBPR Approach (R01 AA 020629; PI: Mark Wolfson, Co-Is: Beth Reboussin, Scott Rhodes, Erin Sutfin, Kim Wagoner) The major goals of this project are to use a community-based participatory approach to assess the impact of local social host ordinance development, passage, and enforcement. Specifically, we will partner with coalitions in 12 Intervention communities and 12 Delayed Intervention communities to build community capacity and mobilize communities to pass and enforce local social host ordinances. We will assess the impact of this intervention on passage of social host ordinances, law enforcement focus on underage drinking parties, community norms regarding these parties, and awareness of potential hosts of enforcement and sanctions. We will also examine the impact of the intervention on changes in hosting behavior, youth behavior, and more distal behavioral and community outcomes. The research team at Wake Forest School of Medicine will partner with Community Anti- Drug Coalitions of America, a Coalition Advisory Board, and coalitions in 24 local communities to carry out this project.

    • Using CBPR to Reduce HIV Risk Among Immigrant Latino Men (5R01MH087339-04 ; PI: Scott Rhodes). Our community-university partnership is jointly conducting a 5-year quasi-experimental study to refine, fully implement, and rigorously evaluate a lay health advisor (LHA) intervention designed to increase condom use and HIV testing among recently arrived, Spanish-speaking, less-acculturated Latino MSM who are settling in the rural Southeast. The intervention is based on social cognitive theory and theory of empowerment education and was developed using community-based participatory research (CBPR). Quantitative assessment data will be collected from each LHA (n=20) and the 12 members of his social network (n=240) longitudinally at: (1) baseline, (2) immediate post- intervention, and (3) 12-month follow-up. This is an "intent-to-treat" study, in which participant data are analyzed based on their randomization group. We hypothesize that participants in the HIV prevention intervention, relative to those in the delayed- intervention comparison group, will demonstrate (1) increased self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV testing.
    Last Updated: 06-18-2014
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