Post-Doctoral Training Grant In Cancer Survivorship

Funded Research

Currently 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: Symptom Management & Quality of Life, Rural Cancer Survivors/Health Disparities,  Lifestyle Interventions,  Tobacco Control,  Cognition, and eHealth.

       Symptoms Management & Quality of Life

  • Reducing Lung Cancer Survivor Anxiety (RELAX) with Brief Device-Guided Breathing. (PI: Danhauer, PhD; Kathryn Weaver, PhD) 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 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 NCI Community Oncology Research Program Research Base (WF NCORP RB). Participants are randomly assigned to one of three groups: low-dose (15 minutes, once per day) RESPeRATE device-guided breathing (n=25), high-dose (15 minutes, twice per day) RESPeRATE (n=25), and a control device (15 minutes, once per day) (n=25). 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 NCORP RB that can better elucidate the impact of the proposed simple intervention for anxious, post-treatment ESLC survivors, that can be easily disseminated. A pilot grant funded through the Wake Forest Center (PIs: Timothy Howard, PhD, Danhauer) for Integrative Medicine is funding a supplement to this study that examine whether changes in anxiety attributed to device-guided breathing are correlated with epigenetic (DNA methylation) and/or gene expression changes.

  • Acupuncture for the Treatment of Hot Flashes. (1 R01 AT005854;PI: Avis, PhD) 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 study is currently funded to study the short and long-term effectiveness of acupuncture for hot flashes (R01 AT005854 “Acupuncture for Hot Flashes” PI: Avis). This randomized trial recruited 200 women who were randomized to acupuncture or waitlist control.  Women in the acupuncture group were allowed to receive up to 20 treatments over 6 months.  They were then followed for an additional 6 months. Primary outcomes are frequency and severity of hot flashes.  Secondary outcomes include sleep, quality of life, hot flash interference, and other symptoms.   Data collection has been completed and data are available for multiple manuscripts.

  • Investigating Mechanisms to Explain Age Associated Differences in Quality of Life among Breast Cancer Patients  (PI: Nancy Avis, PhD). The purpose of this study was 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 longitudinal study enrolled over 650 women recently diagnosed with breast cancer and followed them for 2 years post diagnosis.  Data collected included measures of quality of life, depression, psychosocial factors (e.g., social support, coping, posttraumatic growth, spirituality, and optimism), sexual function, illness intrusiveness, symptoms, and detailed treatment data.  This project has already led to 9 publications to date with another 6 in progress.  This dataset provides a rich resource for manuscripts related to cancer survivorship.   
  • A Prospective Study of the Impact of Breast Cancer on Symptoms and Functioning. (1 R01 CA 199137; PI: Nancy Avis, PhD). This recently funded study takes advantage of the longitudinal  Study of Women’s Health Across the Nation (SWAN) (3U01 AG12546; Wake Forest PI: Nancy Avis) cohort to determine the impact of breast cancer diagnosis and treatment on symptoms, functioning, and quality of life in a multiethnic/racial cohort of women who developed incident breast cancer during the 20 years of the SWAN study. SWAN is unique in having:  a) a large cohort comparison group, allowing comparison of outcomes in breast cancer survivors to those in cohort members who did not develop cancer;  b) pre-diagnostic data; and c) a wide-ranging set of outcomes measured multiple times. We will examine relevant outcomes, measured pre- and post-diagnosis, and assess change over time among BCS compared to SWAN cohort women without cancer.  We will use SWAN’s high sensitivity C-reactive protein (hs-CRP) data to explore relations between inflammation and each outcome.  We also plan to recontact breast cancer survivors to obtain additional data specific to cancer survivors.  We will analyze the extensive SWAN data using varied statistical techniques, e.g., latent growth and hidden Markov analyses, to provide a comprehensive view of the impact of breast cancer and to consider multiple outcomes jointly.         
  • Meta-Analysis of Positive Psychology Interventions for Cancer (MAPPIC) (R03 CA184560 PI: Salsman).  The objective of this study is to provide a comprehensive summary and meta-analysis of interventions that enhance positive affect, self-efficacy, and meaning and purpose as primary or secondary outcomes and to identify those that have been optimally beneficial for patients with cancer.

  • Assessment, Development, and Application of Positive Psychology Theory and Science for Cancer (K07CA158008-01A1 PI: Salsman).
    The purpose of the proposed research is to develop innovative measures of positive functioning for use in patient care research using modern measure development strategies. We will examine the relationship of these positive variables to important outcomes such as physical symptoms, quality of life, and health behaviors in a group of cancer patients and survivors. These results will help us understand the role of positive psychological functioning in the cancer experience, including insight into future interventions to help improve coping and quality of life in people with cancer.

       Rural Cancer Survivors/Health Disparities 

  • Prevalence and Health Status of Cancer Survivors in the Rural. (R03CA156641-02; PI: Kathryn Weaver, PhD, Co-I. 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: Kathryn Weaver, PhD, Co-Is:  Julia Lawrence, DO, L. Douglas Case, PhD)The purpose of this study was 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.

  • A Primary Care Multilevel mHealth Colorectal Cancer Screeing (MCRC) Intervention. (R01CA178941; PI: David Miller). Colorectal cancer (CRC) screening saves lives yet remains underutilized in the United States, with approximately 1 in 3 eligible Americans remaining unscreened. Prior research has documented numerous barriers to CRC screening, including patient factors (i.e., lack of awareness of screening options, negative attitudes and beliefs, low health literacy) and provider/system factors (i.e., lack of physician time, scheduling barriers, absence of after-visit patient support). Prior attempts to increase CRC screening have generally targeted either patient or provider/system barriers, with only modest results. To achieve the highest screening rates possible, a multilevel intervention that is time-efficient, easily implemented, and appropriate for varying literacy levels is urgently needed. The increasing popularity of user-friendly mobile devices makes mHealth, or the use of mobile technology to enhance patient care, an attractive option. We have designed an innovative low cost intervention to increase the receipt of CRC screening by leveraging mobile technology to inform, activate, and support patients before, during, and after their primary care visits. Our intervention can be easily disseminated and implemented in primary care practices and is appropriate for patients of all literacy levels. This project will evaluate the efficacy of our innovative multilevel mHealth CRC screening intervention (mCRC). The conceptual framework for the mCRC system is based on the social cognitive model emphasizing reciprocal determinism, or the dynamic interaction of the person, the behavior, and the environment. The mCRC system includes: 1) a tablet CRC screening decision aid that will collect patient information, deliver a screening message, and allow patients to make a screening decision; 2) "self-service" protocols that empower staff to order patient-requested screening tests; and 3) post-decision follow-up support for patients via automated and interactive text messaging. We will test the mCRC system in a randomized controlled trial conducted in community-based primary care practices serving a racially and socioeconomically diverse population. Patients will be randomized to either the mCRC system or a tablet educational program about healthy lifestyle habits. The trial will evaluate: 1) the ability of the mCRC system to increase receipt of CRC screening within 24 weeks as confirmed by medical chart reviews; 2) the potential mechanisms of change by which the mCRC system facilitates screening (i.e., patient ability to form a screening decision, patient attitudes and beliefs, patient self-efficacy, patient intention, and the occurrence of patient-provider CRC screening discussions); and 3) the additional cost of the mCRC system per patient screened, focusing on the system costs of staff time and technology. At the completion of our study, we will make the mCRC system freely available to help increase CRC screening and improve public health.

    • FoRtitude: Targeted eHealth intervention to reduce fear of recurrence among breast cancer survivors (1R21CA173193-01A1; PI: Lynne Wagner, Ph.D.) is a study to develop and evaluate an eHealth intervention to teach breast cancer survivors (N = 196) coping skills to manage fear of cancer recurrence. Participants completed a 4-week web-based program and outcomes will assess fear of recurrence, anxiety and secondary endpoints at 4- and 8-weeks post-program completion.
      • COMPASS: Capturing and Analyzing Sensor and Self-Report Data for Clinicians and Researchers (HHSN261201300055C; Wake Forest PI: Lynne Wagner, Ph.D.; PI: F. Albinali, EveryFit, Inc.) is a Small Business Innovative Research (SBIR) grant awarded to EveryFit, Inc. and is being conducted in partnership with Northwestern University and Wake Forest University. The purpose of this project is to develop a device agnostic platform that measures and delivers customizable, evidence-informed supportive care and rehabilitation services to cancer survivors using mobile phones, tablets, and objective sensors with the integration of patient-reported outcomes data. 

        Lifestyle Interventions
      • 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.

             Tobacco Control 

      • End of Treatment Transition to Follow-Up Care among Early Stage Lung Cancer Survivors. (R03CA179019, PI: Weaver, PhD, Co-Is: Janet Tooze, PhD, James Urbanic, MD, William J. Petty, MD, Jimmy Ruiz, MD).  This mixed-methods study focuses on an understudied, but growing population, early stage lung cancer survivors to gather novel data on their follow-up care transition experiences and needs. This study recruited 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.

      • Smokeless Tobacco Use in College Students. (5R01CA141643; 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 are measuring trajectories of SLT use among undergraduate college students over the course of their college careers; identifying environmental and individual-level correlates of trajectories of SLT use; and examining 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, DrPH). 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.

      • Effective Communication on Tobacco Product Risk and FDA Authority. (NCI/FDA, PI: Kurt Ribisl, UNC; PD: Erin Sutfin, PhD; Co-Is: Reboussin, PhD, Mark Wolfson, PhD).  The goal of the center 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. Researchers in the center  are conducting three integrated research projects among vulnerable populations and across the lifespan to inform regulatory science. The project led by Dr. Sutfin aims to develop and test messages for novel tobacco products to effectively communicate product risk to adolescents and young adults.  


      • Women’s Health Initiative Memory Study (PI: Sally Shumaker, Co-I: 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.
      • Phase III Study of Donepezil in the Irradiated Brain (R01 NR009675-01A2;PI: Steve Rapp)  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.

              Other Opportunities for Trainees 

      • Wake Forest NCORP Institutional Research Base. (5UG1CA18982402; PI: Glenn Lesser; Co-PI; Kathryn Weave). The Wake Forest NCORP Cancer Center Research Base continues to utilize the unique resources and expertise of the established and productive Wake Forest Cancer Center CCOP Research Base and builds on established collaborations with our NCORP community partners, consultants and other Research Bases to address cancer and treatment-related symptoms and toxicities, cancer care delivery issues, and cancer related health disparities in community cancer centers. NCORP emphasizes studies that complement our established thematic areas of expertise in cardiovascular complications and survivorship and addresses key issues in clinical management of oncology patients (e.g., transitions in care, strategies for addressing cardiovascular and cancer recurrence risk factors) and behavioral self-management for patient (e.g., smoking, adherence, and physical activity.

      • The ECOG-ACRIN Community Oncology Research Program (NCORP) Research Base (1UM1CA189828-01; M-PI: Lynne Wagner, Ph.D.) provides access to a diverse multi-disciplinary national scientific community that is dedicated to developing and conducting clinical trials and correlative research studies across the continuum of care from prevention, early detection and diagnosis, to cancer control and survivorship with dedicated expertise in cost effectiveness, patient-reported outcomes, healthy equity and disparities, and cancer care delivery research. There are ample opportunities to participate in the analysis and dissemination of completed trials, including the analysis of patient-reported outcomes data from cancer treatment trials, and to contribute to cancer control trials in development.

      • The Atherosclerosis Risk in Communities (ARIC) Cancer Epidemiology Cohort (CEC). (U01 CA164975-Platz) (PIs –Forsyth County Site-Vitolins, Tooze)  In 1987, 15,792 participants aged 45-64 years were recruited by 4 Field Centers: Forsyth Co., NC; Jackson, MS; Minneapolis, MN; and Washington Co., MD. 55% female and 27% African-American to participate in ARIC. The ARIC study is a prospective cohort study investigating the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors,medical care and disease by race, gender, location, and date. Despite the wealth of measured anthropometric, lifestyle, and medical data,including 4 clinical visits; repeated biospecimens and biomarkers pertinent to cancer; the annual and now semi-annual phone interviews to obtain updated medical data; the completed GWAS on all participants and planned whole genome sequencing; approved linkage to Medicare; 25-year follow-up with >90% response rate; high African-American representation; established links with hospitals in ARIC areas; and existing operations and data use protocols, ARIC has never been viewed or used as a CEC. This grant provides the infrastructure and funding to collect cancer information needed for studies on incidence, mortality, recurrence, progression, and case-fatality such as stage, grade, histology, location (colon), laterality (breast), receptors (breast), initial treatment, and subsequent treatment.  The overall goal of ARIC Cancer is to have fully annotated cancer cases in ARIC.
      • 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: 11-01-2015
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